MOU 225-24-004
MEMORANDUM OF UNDERSTANDING
BETWEEN THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION,
U.S. DEPARTMENT OF LABOR
AND THE FOOD AND DRUG ADMINISTRATION,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
I. PURPOSE
This Memorandum of Understanding (MOU) is entered into by the United States Department of Labor, Occupational Safety and Health Administration (OSHA), and the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) (collectively "the agencies" or “the parties,” individually "party" or "agency"). The agencies share the goal of protecting the safety and health of workers in facilities where FDA regulated products are produced, processed, or held. The purpose of this MOU is to facilitate information sharing between the agencies with respect to matters affecting the occupational safety and health of workers and the safety and security of our nation's medical products, cosmetics and food supply in facilities where FDA regulated products are produced, processed or held. In addition, this MOU addresses information sharing between the agencies related to the Food Safety Modernization Act’s (FSMA) whistleblower protection provision and FDA’s agreement to inform workers of their right to file a complaint with OSHA under that provision.
II. BACKGROUND AND AUTHORITY
FDA and OSHA recognize the importance of close cooperation and collaboration. On September 16, 2010, the agencies signed a Joint Statement affirming their mutual commitment to sharing relevant health and safety-related information and exploring options to establish formal communication procedures. The agencies formalized their collaboration on June 6, 2011, when they signed a memorandum of understanding (MOU). This MOU supersedes the June 6, 2011 MOU.
FDA is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act (FFDCA), and other laws. In fulfilling its responsibilities under these laws, FDA's activities are directed toward protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. This is accomplished, in part, by inspecting the production, processing, and distribution of products and examining samples thereof to ensure compliance with applicable requirements.
OSHA is charged with the enforcement of the Occupational Safety and Health Act of 1970 (OSH Act), under which employers are responsible for providing safe and healthful workplaces for their employees. OSHA's role is to assure these conditions for America's working men and women by setting and enforcing standards, and providing training, education and assistance related to employee safety. OSHA is also charged with the enforcement of the Food Safety Modernization Act (FSMA) whistleblower protection provision, section 1013 of the FFDCA, 21
U.S.C. 399d, which protects employees from discharge or other retaliation by their employers for making complaints about food safety concerns or other violations of the FFDCA or engaging in other protected activities.
When inspecting FDA regulated medical, cosmetic and food product facilities for safety, quality, and health hazards or investigating whistleblower complaints under FSMA in furtherance of their responsibilities, FDA investigators, OSHA compliance officers and OSHA whistleblower investigators may observe conditions or obtain information from employees and other parties relevant to the other agency's safety or health mission. FDA and OSHA are committed to sharing information on current good manufacturing practices (cGMP), health or safety-related problems or retaliation issues that may be relevant to the regulatory and enforcement responsibilities of the other agency to the extent that is feasible.
III. AREAS OF COOPERATION
The FDA and OSHA will share relevant information with each other, while ensuring that the exchange of such information complies with applicable law.
A. Referrals of Information
In accordance with the Information Sharing provisions under Section IV, the parties agree to the following:
If FDA, in its inspections of facilities, has reason to believe that a potential violation of an employer’s obligations under the OSH Act or an OSHA standard or regulation has occurred, FDA will provide this information to OSHA to the extent that is feasible. This may include observations made directly by FDA personnel, as well as information received from other parties, including workers. OSHA may provide information that FDA designates as public information with States that operate OSHA-approved State Plans (OSHA State Plans); non- public information that FDA has provided to OSHA will only be shared with OSHA State Plans as approved by FDA in accordance with FDA’s disclosure regulations.
If, in FDA’s inspections of facilities where food is manufactured, processed, packed, transported, distributed, received, held, or imported, an individual notifies FDA that the individual has been subject to retaliation from their employer for raising concerns about food safety or other violations of the FFDCA, FDA shall promptly inform the individual that a remedy for retaliation is available through OSHA, rather than FDA, and that the individual should personally contact OSHA. FDA will provide the individual with appropriate contact information for OSHA and will advise the individual that the law requires that retaliation complaints be filed with OSHA within 180 days of the alleged retaliation.
If OSHA, in its investigations of facilities where FDA regulated products are produced, processed, manufactured or held has reason to believe that factors are present which may indicate a possible violation of FDA standards, OSHA will provide this information to FDA, to the extent feasible. This may include observations made directly by OSHA personnel, information provided to OSHA by an OSHA State Plan, and information received from other parties, including workers. FDA will not further share OSHA provided information with state partners as a routine practice. FDA may choose to further share in accordance with FDA disclosure regulations when essential to support the FDA mission.
B. Communication Procedures
The FDA and OSHA agree to maintain a practicable process including procedures and criteria for information sharing and a plan for implementation.
OSHA agrees to send to the FDA copies of the whistleblower complaints it receives under Section 1013 of the FFDCA, 21 U.S.C. 399d, as well as any findings and preliminary orders that OSHA issues, including findings and orders dismissing complaints on the basis of a settlement or because of withdrawal of the complaint. The FDA will review all copies of whistleblower complaints FDA receives from OSHA.
C. Training
The FDA and OSHA agree to develop and implement a plan for training appropriate employees based on the priorities and needs of each organization to meet the intention of this MOU.
IV. INFORMATION SHARING
1. The Parties recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure: (1) confidential commercial or financial information, such as information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA) (5 U.S.C. § 552(b)(4)); (2) personal privacy information, such as the information that would be protected or exempt from public disclosure pursuant to FOIA Exemptions 6 or 7(C) (5 U.S.C. § 552(b)(6) or 7(C); (3) information compiled for law enforcement purposes, such as information that would be protected or exempt from public disclosure pursuant to FOIA Exemption 7(E) (5 U.S.C. § 552(b)(7)(E)); or (4) information that is otherwise protected from public disclosure by federal statutes and their implementing regulations, e.g., the Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), other FOIA exemptions not mentioned above (5 U.S.C. § 552(b)), the FD&C Act (21 U.S.C. §§ 301 et seq.), the Health Insurance Portability and Accountability Act (HIPAA), (Pub. L. 104-191), Section 319L(e) of the Public Health Service Act (42 U.S.C. § 247d-7e(e)), and disclosure restrictions subject to the Procurement Integrity Act (41 U.S.C. §§ 2101-2107) and Federal Acquisition Regulation (48 CFR § 3.104). Additionally, all federal agencies and contractors supporting them are under the Federal Information Security Management Act (FISMA), E-government Act of 2002 (Pub. L. 107-347). Pursuant to sections 301(j) and 520(c) of the FD&C Act (21 U.S.C. § 331(j) and 360j(c)), FDA will not reveal to any participant who is not a representative of an agency within the Department of Health and Human Services any information entitled to protection as a trade secret or confidential commercial or financial information relating to FDA regulated products obtained by FDA under sections 513, 514, 515, 516, 518, 519, 520(f), 520(g), or 704 of the FD&C Act (21 U.S.C. 360c, 360d, 360e, 360f, 360h, 360i, 360j(f), 360j(g), 374), unless there is in place a written authorization, from the owner of that information, or in accordance with all requirements of 21 C.F.R. § 20.85, that permits FDA to reveal such information to representatives of non-HHS agencies. Such authorization may be obtained in the form attached as Exhibit A of this MOU. Similarly, pursuant to section 15 of the OSH Act, 29 U.S.C. 664, OSHA will not reveal any information reported to or otherwise obtained in connection with any inspection or proceeding under this Act which contains or which might reveal a trade secret.
2. The Parties will each establish proper safeguards to ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable laws, regulations, and this MOU. Access to such information shared under this MOU shall be restricted to authorized employees, agents, and officials of the Parties who require access to perform their official duties in accordance with the uses of information as authorized by this MOU. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards required to protect the information; and (3) the administrative, civil, and criminal penalties for noncompliance. Such personnel shall be advised the information may contain protected, privileged, or confidential non-public information, and cannot be disseminated, distributed, or copied to persons who are not performing work under the same FDA contract and single-signature non-disclosure agreement. Except as otherwise permitted under this MOU, each Party agrees that information shared pursuant to this MOU will not be further disclosed without the written permission of the sharing Party or as required by law with advance notice to the sharing Party. In the event disclosure is required by law, the disclosing party shall consult with the sharing party prior to such disclosure (i.e., consultation between the information-sharing liaisons or designees for the Parties). The procedures established under Section III must include proper safeguards against unauthorized use and disclosure of the non-public information exchanged under this MOU. OSHA and the FDA will protect the data in accordance with the Privacy Act of 1974, Federal regulations at 20 CFR Part 603, and all other requirements related to confidentiality and disclosure avoidance described in this MOU. The agencies commit to ensuring that all data received is held in confidence and to use the data only for approved purposes. Upon receipt, all data acquired as a result of this MOU will be treated as if it has, at a minimum, protection at the appropriate risk level in accordance with the National Institute of Standards and Technology (NIST) Federal Information Processing Standards (FIPS) 200 and Special Publication 800-60. The parties agree to work together to ensure the joint security of data transmitted between their systems. Each party certifies that its respective system is designed, managed, and operated, and that data is transferred, managed and used in compliance with all relevant Federal laws, regulations, and policies. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be shared and used consistent with the Trade Secrets Act, 18 U.S.C. 1905, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Freedom of Information Act, 5 U.S.C. 552, and any other applicable Federal law and regulations. Pursuant to FFDCA section 301(j), 21 U.S.C. 33J(j), FDA will not reveal to OSHA any method or process which is entitled to protection as a trade secret. Similarly, pursuant to section 15 of the OSH Act, 29 U.S.C. 664, OSHA will not reveal any information reported to or otherwise obtained in connection with any inspection or proceeding under this Act which contains or which might reveal a trade secret.
3. Contractors, their subcontractors, and/or agents of the Parties participating in discussions covered by this MOU will be permitted to participate in discussions and to receive information under this MOU only if they require access to perform their official duties in accordance with the uses of the information and have signed an agreement (e.g., contractor or business associate non- disclosure agreement) by which they will commit to keep the information confidential (form attached as Exhibit B).
4. The Parties agree that requests for information, subject to this MOU, and responses to such requests, will be submitted in writing (or conveyed orally in an emergency) with the appropriate disclosure statements for information requests, responses, and documents provided, using the model request and response letters (or a reasonable, mutually agreed upon variation) as described in Exhibit C.
5. The Parties agree to promptly notify an affected Party of any actual or suspected unauthorized disclosure of information shared under this MOU. The Parties are similarly under an affirmative obligation to report breaches of Personally Identifiable Information (PII), which might include Protected Health Information (PHI), or Individually Identifiable Health Information (IIHI), under appropriate authorities and timeframes, such as FISMA, HIPAA, the Privacy Act, and the Health Information Technology for Economic and Clinical Health (HITECH) Act (Pub. L. No. 111-5, 123 Stat. 226 (Feb. 17, 2009); 42 U.S.C. §§300jj et seq.; §§17901 et seq.).
6. If a Party receives a FOIA request for records or information shared by another of the Parties pursuant to this MOU that are responsive to the request, the Party receiving the request will follow its FOIA regulations regarding referral, consultation, or coordination, working with the sharing party to ensure the sharing party’s FOIA regulations are followed for disclosure. The receiving Party will ensure final disclosure decisions are made by the sharing Party (originating agency of the records or information) including decisions on whether the records are responsive or able to be disclosed.
7. The Parties agree that each Party may decide not to share information or expertise in response to a particular request made for information, or to limit the scope of information and expertise shared in response to a particular request. A decision not to share information in response to a specific request may be based on several factors, including, for example, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding Party’s priorities, or legal restrictions. The Parties further agree that a Party may on its own initiative elect to share information pursuant to the procedures established, above, to further the purposes of this MOU. In the event the relevant Parties cannot reach consensus on a decision to share or not share information, the issue will be referred to an official designated by the Parties, specified in procedures to implement this MOU.
8. The Parties further agree that nothing in this MOU shall be construed to prevent a disclosure required by law or legal process. Notwithstanding this provision, the requesting Party will promptly notify a liaison or designee of the sharing Party before complying with any judicial order that compels the release of non-public information shared pursuant to this MOU, or any other attempt by a third party to obtain shared non-public information by compulsory process, including but not limited to a subpoena, discovery request, or litigation complaint or motion, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action (e.g., to provide an opportunity to seek to intervene and block the disclosure). This MOU does not prohibit disclosure of information that is available publicly or when authorized in writing by the sharing Party.
Nothing in this MOU shall be construed to prevent a Party from complying with an official request of the United States Congress, the Office of Inspector General, or the Government Accountability Office. The requesting Party will promptly notify the liaison or designee of the sharing Party of any attempt by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information so that the Parties may determine the appropriate response and measures to take to protect the information from disclosure. The Parties shall consult before complying with any request to obtain shared nonpublic information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.
9. The Parties agree that termination of the MOU does not relieve them of their confidentiality obligations established under this MOU, including their obligations to safeguard and limit access to all information provided pursuant to this MOU. 10. This MOU does not address, and has no effect on, the application of, or compliance with, any requirement or restriction on disclosure for national security purposes. Any national security clearance requirements or restrictions applicable to classified information (e.g., “confidential,” “secret,” “top secret”) that may be shared by or among the Parties must be satisfied independent of this MOU.
V. EFFECT OF THIS AGREEMENT
This MOU supersedes the OSHA/FDA MOU signed on June 6, 2011. This MOU is an internal government agreement. It does not create binding, enforceable obligations against either agency. It is not intended to, and does not, confer upon any private person or employer, or other entity any rights against the United States or any of its agencies or officers.
Nothing in this MOU shall be interpreted as limiting, superseding or otherwise affecting either agency’s normal operations or decisions in carrying out its statutory or regulatory duties. This MOU and all associated agreements shall be subject to the applicable policies, rules, regulations, and statutes under which FDA and OSHA operate. This MOU does not limit or restrict the agencies from participating in similar activities or arrangements with other entities.
This MOU does not itself authorize the expenditure or reimbursement of any funds. Nothing in this agreement obligates the parties to expend appropriations or enter into any contract or other obligation.
VI. LIAISON OFFICERS
To facilitate the activities carried out under this MOU, each agency will establish appropriate agency liaisons.
For OSHA enforcement-related matters: Directorate of Enforcement Programs, OSHA- DOL, 200 Constitution Avenue NW, Washington, D.C. 20210; Telephone: 202-693-2100.
For OSHA FSMA whistleblower matters: Directorate of Whistleblower Protection Programs, OSHA-DOL, 200 Constitution Ave NW, Washington, D.C. 20210; Telephone: 202-693-2199.
For FDA enforcement-related matters: Division Director, Office of Regulatory Affairs, Office of Partnerships and Operational Policy, Division of Compliance and Enforcement.
Each agency may designate a new liaison at any time by notifying the other in writing. If at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the agency will name a new liaison and notify the other agency through the designated liaison.
VII. EFFECTIVE DATE
This MOU will take effect immediately once signed by both parties and shall continue in force for five years, unless both agencies agree in writing to extend the length of the MOU. The MOU will be reviewed annually. The MOU may be terminated by either party upon 90 days written notice to the other agency. Except as expressly provided in this agreement, this MOU constitutes the entire agreement between OSHA and FDA with respect to the matters set forth herein.
Approved and Accepted
for the U.S. Department of Labor
Signed by: Douglas L. Parker
Assistant Secretary for Occupational Safety and Health
/s/
Date: 01/08/2024
Approved and Accepted
for the Food and Drug Administration
Signed by: Michael C. Rogers, MS
Associate Commissioner for Regulatory Affairs
/s/
Date: January 26, 2024
APPENDIX A – INFORMATION SHARING PROCEDURES EXHIBIT A - MODEL AUTHORIZATION FOR FDA TO SHARE NON-PUBLIC
INFORMATION WITH OSHA PARTNERS
[To be completed on sponsor/information-owner letterhead]
To: FDA AGENCY EMPLOYEE, ACRONYM OF OFFICE (MAILING CODE)
From: Director, Office of Policy, Compliance and Enforcement
Date: DATE
Subject: Authorization to Share Food and Drug Administration Information with [AGENCY] re: [FIRM]
In accordance with Title 21, Code of Federal Regulations, section 20.85 (21 CFR § 20.85), you, or any other employee(s) of [CENTER] who may have custody of responsive records and/or information are authorized to disclose non-public records and/or information to [PERSON AND AGENCY TO WHOM INFORMATION RELEASED]. The [REQUESTOR’S] requests access
to the following nonpublic information: [INFO.]
The purpose for which the information is requested is to assist in the [REQUESTOR’S AGENCY] investigation of whether FIRM NAME or a related entity or subsidiary failed to [REASON]. The records will only be used for the following authorized law enforcement activity: [LAW] [ENFORCEMENT ACTIVITY]
You may share the information with the [AGENCY NAME] official who signed the non- disclosure agreement or his or her designee. If you share non-public information, please advise the requestor that they may not further disclose such information except with my written permission with anyone outside of those listed in the DATE request and non-disclosure agreement.
Please note that this authorization does not include information that the FDA is prohibited from disclosing by law. See 18 U.S.C. § 1905; §§ 301(j) and 331(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331 et seq., and 21 C.F.R. § 20.85. Therefore, you cannot release any information prohibited from disclosure by these statutes to the requestor without the sponsor’s/owner’s authorization (e.g., trade secrets, certain confidential commercial information, etc.). If you are unsure if certain responsive information is prohibited from disclosure, please contact the Freedom of Information (FOI) Officer in your Center or FDA’s Division of FOI (HFI-35) to request an opinion.
If you are requested to provide a statement (deposition), you should contact Jaime Espinosa since a deposition is testimony and, as such, it is not covered by 21 C.F.R. § 20.85. Rather, testimony requires approval pursuant to 21 CFR § 20.1, and the AGENCY must submit a written request conforming to that regulation.
You may directly transmit to the [AGENCY] any information as authorized above. Please send the Office Strategic Planning and Operational Policy a copy of the outgoing transmittal letter and a summary of the agency information released.
If you have any questions about these procedures or this policy, please contact [TS’ Information].
Director, Office of Policy, Compliance and Enforcement
EXHIBIT B - DOL/OSHA,
FDA Partnership Confidentiality Commitment
OSHA and FDA frequently coordinate interagency efforts and are responsible for, inter alia, researching, setting and enforcing standards and regulations to ensure the occupational safety and health of workers and the safety and security of our nation's food supply in facilities where FDA regulated products are produced. As part of participation in meetings, discussions, or other communications, I understand that I may be exposed to information that is trade secret, confidential commercial or financial information, personal privacy information, or pre-decisional or deliberative information that has been provided to, or belongs to, an agency or department that is a member of the collaborative group.
I, on this _ day of _, 20_, hereby agree that I shall not release, publish, or disclose such information, including disclosure in publications and public meetings, and I shall protect such information in accordance with all applicable laws relating to my receipt of non-public information in connection with my participation in OSHA/FDA partnership activities, and that I may be subject to disciplinary action and, in some cases, administrative, civil and/or criminal penalties as prescribed by law for unlawful disclosure of such information. I shall use such information in accordance with my official duties and shall share such information only with individuals who either (1) are employed by, or a contractor of, the originating government agency that provided the information to me or to my agency and are
authorized to have access to the information by virtue of their duties, or (2) are employed by, or a contactor of, a collaborating agency and have themselves signed a Confidentiality Commitment.
Signature:_
Date: _
Type or Print Name:
Agency:
Supervisor Signature (if applicable):
Date:
Type or Print Supervisor Name: _
EXHIBIT C
Requests for information subject to the MOU that involve DOL/OSHA and/or FDA/ORA, including meeting requests, which may include email or calendar invitation, will be transmitted in writing and follow the format below:
YOUR AGENCY’S LETTERHEAD
Please copy and paste onto your agency’s letterhead
Attn: Information Sharing Specialist Division of Information Disclosure Programs Office of Partnerships
Office of Regulatory Affairs Food and Drug Administration 12420 Parklawn Drive Element Building, 4th Floor Rockville, Maryland 20857 ORAInfoShare@fda.hhs.gov
Dear Information Sharing Specialist,
The YOUR AGENCY’s NAME AND OFFICE requests access to the following non-public information (list the type of records/information requested, including the firm and/or product name and the relevant timeframe) __________ pursuant to 21 C.F.R. § 20.85: LIST THE INFORMATION YOU ARE REQUSTING IN DETAIL (Requests for all documents, or all communications relating to a product/firm, if usually overly broad and can result in processing delays).
The purpose for which the information is requested is to assist in the STATE THE NATURE OF YOUR INTEREST. The records will only be used for the following authorized activity: STATE THE ACTIVITY. (In addition, indicate whether the request for information is the result of an ongoing investigation, and if so, give the details.)
I certify that the ACTIVITY is authorized by law, that the records or information will be used only for the stated purpose and will not be disclosed outside YOUR AGENCY AND OFFICE without the prior written permission of the Food and Drug Administration. I also certify that disclosure within YOUR AGENCY will be limited to the specific purpose stated above, and that I will provide a copy of this letter to any person(s) with whom I share the non-public information.
I understand that 21 U.S.C. § 331 of the Federal Food, Drug, and Cosmetic Act prohibits disclosure of trade secret information outside the Department of Health and Human Services. If you have any questions, please contact PROVIDE NAME AND CONTACT INFORMATION.
Sincerely,
YOUR SIGNATURE LINE
cc: RECOMMEND INSERTING NAME OF YOUR FDA CONTACT, IF ANY.
Responses by the sharing Party will be transmitted by letter, along with any non-public information shared, indicating the type of information (e.g., confidential commercial or financial information, personal privacy, pre-decisional, etc.), and should include the following statement: "Pursuant to the FDA Memorandum of Understanding ###-##-###, this letter accompanies agency records [Sharing Party] is sharing with [Requesting Party] in response to [Requesting Party’s] request, dated [insert date]. These agency records contain one or more of the following categories of non-public information:
_ Confidential commercial or financial information
Personal Privacy Information
_ Information subject to the Privacy Act
Intra-agency records
_ Records or information compiled for law enforcement purposes
Information protected for national security reasons; or
_ Other [insert description]
This response includes non-public information that is being shared under the terms of the MOU referenced above, which obligates [Requesting Party] to prevent onward disclosure or sharing of the information in any manner without the written permission of [Sharing Party] or as required by law with advance notice to the sharing agency, as described under the terms of the MOU. Recipients of such information must have a signed DOL/OSHA, FDA/ORA Confidentiality Commitment on file with your agency.
[Name and Title of Official authorized to respond on behalf of agency/office]"
The shared documents containing non-public information should be marked “Do not disclose without permission of [Insert Name of Sharing Party].”
In an emergency, if submitting written request or response is not feasible, this information may be conveyed orally consistent with all other terms of the MOU.
In cases where a Party to this MOU needs to obtain certain information as soon as possible due to emergency circumstances, such as an outbreak of an illness, or if required by law, the Requesting Agency shall so indicate orally or through informal written communication, e.g., email, to the other Party. The Requesting agency shall agree to protect any such information from unauthorized disclosure. In the case of emergency circumstances or if required by law, as soon as is practicable, the Parties to this MOU shall document their sharing of any non-public information.
Model Transmittal Letter FOR FDA TO SHARE NON-PUBLIC INFORMATION WITH OSHA PARTNERS
RECIPIENT NAME
ADDRESS
Dear Mr./Ms. :
This letter is in response to your letter of (Insert Date), requesting and agreeing to maintain the confidentiality of this information.
After a review of Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) records, we have the following information to provide pursuant to 21 CFR 20.85:
- This nonpublic information is provided for official use only and is to be used only for the stated purpose in your request. It may contain protected, privileged, or confidential non-public information and cannot be disseminated, distributed, or copied to persons who are not covered under the associated 20.85 information sharing agreement (ISA) this information was originally shared under. You may share this material only with members of your staff who are also covered by the same 20.85 ISA, specifying they can receive and review the type of official FDA information being shared. You are not permitted to divulge this material outside of your agency or with anyone not covered under the 20.85 ISA. Because this information is being shared under a 20.85 ISA, you must not further release this information unless FDA provides you written permission allowing further disclosure. Moreover, unauthorized disclosure of confidential commercial or personal privacy information obtained from FDA could be a civil or criminal violation and may carry legal consequences for the disclosing official. If you wish to share this information with individuals other than those just described, please contact the FDA’s Division of Information Disclosure Policy (DIDP) at ORAInfoShare@fda.hhs.gov.
If you have any questions with regard to this matter, please feel free to contact me at (put your name or ORA contact)
Your name Title
Division of Information Disclosure Policy Office of Strategic Planning and Operational Policy
Office of Regulatory Affairs U.S. Food and Drug Administration
APPENDIX B LIAISON LIST APPENDIX
Points of Contact for Implementation of MOU at the National Office Level
OSHA-Directorate of Whistleblower Protection Programs:
Director, Directorate of Whistleblower Protection Programs
200 Constitution Ave, NW, Rm. N-3647
Washington, DC 20210
(202) 693-2199
OSHA.DWPP@dol.gov
OSHA-Directorate of Enforcement Programs:
Director, Directorate of Enforcement Programs (DEP)
U.S. Department of Labor/OSHA 200 Constitution Avenue, NW Room N-3119
Washington, DC 20210
(202) 693-2100 Phone
(202) 693-1681 FAX
FDA
Martha Myrick, PE/DDHAFO
Division of Domestic Human and Animal Foods Phone: 240-402-5840
616-304-6283
Email: martha.myrick@fda.hhs.gov
Nicole Williams
Office of Medical Products and Tobacco Operations
Phone: 312-596-4167
312-340-8111
Email: Nicole.Williams@fda.hhs.gov
Points of Contact for Implementation of MOU at the Regional/ Divisional Office Level
OSHA Regional Contacts (Whistleblower and Safety and Health):
OSHA Regional Office |
Contact Information |
STATES COVERED |
| Region 1 |
U.S. Department of Labor/OSHA |
Connecticut Maine Massachusetts New Hampshire Rhode Island Vermont |
| Region 2 | Department of Labor/OSHA 201 Varick Street, Room 670 New York, NY 10014 Phone: (212) 337-2378 Fax: (212) 337-2371 |
New Jersey New York Puerto Rico Virgin Islands |
| Region 3 | U.S. Department of Labor/OSHA 1835 Market Street Mailstop OSHA-RO/19 Philadelphia, PA 19106 Phone: (215) 861-4900 Fax: (215) 861-4904 |
Delaware District of Columbia Maryland Pennsylvania Virginia West Virginia |
| Region 4 | U.S. Department of Labor/OSHA Sam Nunn Atlanta Federal Center 61 Forsyth Street, SW, Room 6T50 Atlanta, GA 30303 Phone: (678) 237-0400 Fax: (678) 237-0447 |
Alabama Florida Georgia Kentucky Mississippi North Carolina South Carolina Tennessee |
| Region 5 | U.S. Department of Labor/OSHA John C. Kluczynski Federal Building 230 South Dearborn St, Rm 3244 Chicago, IL 60604 Phone: (312) 353-2220 Fax: (312) 353-7774 |
Illinois Indiana Michigan Minnesota Ohio Wisconsin |
| Region 6 | U.S. Department of Labor/OSHA A. Maceo Smith Federal Building 525 Griffin Street, Suite 602 Dallas, TX 75202 Phone: (972) 850-4145 Fax: (972) 850-4149 |
Arkansas Louisiana New Mexico Texas Oklahoma |
| Region 7 | U.S. Department of Labor/OSHA Two Pershing Square 2300 Main Street, Suite 1010 Kansas City, MO 64108 Phone: (816) 283-8745 Fax: (816) 283-0547 |
Iowa Kansas Missouri Nebraska |
| Region 8 | U.S. Department of Labor/OSHA Cesar Chavez Memorial Building 1244 Speer Blvd., Suite 551 Denver, CO 80204 Phone: (720) 264-6550 Fax: (720) 264-6585 |
Colorado Montana North Dakota South Dakota Utah Wyoming |
| Region 9 | U.S. Department of Labor/OSHA San Francisco Federal Building 90 7th Street, Suite 2650 San Francisco, CA 94103 Phone: (415) 625-2547 Fax: (415) 625-2534 |
American Samoa Arizona California Guam Hawaii Nevada Northern Mariana Islands |
| Region 10 | U.S. Department of Labor/OSHA 300 Fifth Ave., Suite 1280 Seattle, WA 98104-3212 Phone: (206) 757-6700 Fax: (206) 757-6705 |
Alaska Idaho Oregon Washington |