Memorandum of Understanding
The Department of Health and Human Services
Office for Civil Rights
The Food and Drug Administration
This Memorandum of Understanding (MOU) between the Department of Health and Human Services (DHHS)/Office for Civil Rights (OCR) and the Food and Drug Administration (FDA) is designed to implement the nondiscrimination provisions applicable to programs and activities receiving Federal financial assistance from FDA. The MOU also is intended to implement the Secretary's policy to make civil rights an essential and integral part of every program in the Department
The FDA is a regulatory agency charged with enforcing the Federal Food, Drug, and Cosmetic Act and several other related public health laws. FDA's mandate is to protect the nation's consumers. FDA recognizes its responsibility to adopt program policies, procedures and practices that will assist in achieving the objectives of the civil rights statutes (including Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, Title II of the Americans with Disabilities Act of 1990, the Age Discrimination Act of 1975, Title IX of the Education Amendments of 1972, Titles VII and VIII of the Public Health Service Act and any other applicable program specific legislation) which prohibit discrimination in Federally-funded or operated (e.g., Section 504, 45 CFR Part 85) programs and activities.
In carrying out this responsibility, FDA will ensure that there are no barriers that tend to exclude people from the benefits of its programs because of race, color, national origin, disability, age and sex under limited circumstances. Thus, FDA will attempt to prevent discrimination before it occurs and to assist recipients of its Federal financial assistance in complying with the civil rights authorities prior to the initiation of formal reviews or complaint investigations by OCR.
The DHHS/OCR is responsible for issuing policies, and planning, coordinating, reviewing, and appraising the Department-wide initiative, to incorporate civil rights activities into the program operations of the Department's Operating Division (OPDIVs). This responsibility includes providing technical assistance and support services to FDA for its overall civil rights program implementation. In order to carry out an effective program, DHHS/OCR and FDA will undertake some reciprocal responsibilities. Specifically,
1. assist FDA in preparing internal civil rights policy guidance materials to be used throughout the agency;
2. assist FDA in developing internal civil rights standards and procedures for the conduct of periodic program reviews/audits;
3. assist FDA in developing systems for the collection and review of program information that can be used to identify problems relating to civil rights
4. develop and conduct orientation and training programs for FDA staff on their civil rights responsibilities;
5. assist FDA in the design of training programs to explain civil rights compliance responsibilities to FDA's recipients of Federal financial assistance;
6. work with FDA to identify broad issues that may hinder civil rights compliance and assist FDA in developing appropriate strategies to remedy problems identified;
7. conduct civil rights compliance reviews and complaint investigations involving FDA's programs and activities in accordance with applicable statutes and regulations;
8. develop and establish guidelines for review of FDA's programs regulations, policies, directives, instructions and other issuances to ensure compliance with the Department's civil rights responsibilities;
9. qssist FDA in the development of a Civil Rights Operating Plan to include the selection of programs with civil rights responsibilities and the identification of long range strategies to meet civil rights program requirements; and
10. participate, with FDA, in periodic site visits to FDA financial assistance recipients.
FDA, with OCR assistance, will:
1. develop and issue internal policy guidance on the implementation of nondiscrimination statutes in any of its programs and/or activities receiving Federal financial assistance;
2. review program regulations, directives, and instructions in support of the Department's civil rights authorities;
3. provide briefings to senior officials and program staff to ensure they understand the civil rights responsibilities; initiate orientation and training programs on civil rights requirements;
4. place and maintain a link on the FDA/OEO homepage to the DHHS/OCR homepage;
5. incorporate civil rights concerns into regular review and audit activities of programs receiving financial assistance to assure that benefits and services are delivered equitably to all eligible persons;
6. design a system for the collection of appropriate data on the participation of minorities, women, persons with disabilities, and persons of all ages in FDA-funded programs and activities;
7. furnish technical expertise and assistance to FDA grant recipients about policies, practices and procedures of civil rights compliance;
8. conduct preliminary inquiries to discern whether there is a civil rights problem, resolve failures to comply by informal means whenever possible, and refer unresolved or complex civil rights issues to DHHS/OCR for resolution;
9. participate with OCR in periodic site visits to FDA recipients of Federal financial assistance; and
10. use, to the extent possible, resources to support and promote civil rights in FDA programs.
This MOU sets forth the goals of the joint efforts of FDA and DHHS/OCR to achieve civil rights compliance in FDA programs and activities Federal financial assistance. OCR's Voluntary Compliance and Outreach Division and FDA's Office of Equal Employment, Office of the Commissioner will serve as the lead offices for carrying out the terms of the MOU.
To promote effective and efficient FDA/DHHS-OCR coordination of civil rights activities, FDA/OEO, Office of the Commissioner will serve as the central point of contact with OCR. DHHS/OCR will provide guidance and direction and FDA/OEO, Office of the Commissioner will, in turn, disseminate such information to FDA components. DHHS/OCR will inform FDA/OEO, Office of the Commissioner of planned OCR compliance review and complaint investigations pertaining to FDA recipients. FDA/OEO, Office of the Commissioner will notify its Offices, Centers and field components, as appropriate. Also, OCR will furnish FDA/OEO, Office of the Commissioner copies of Letter of Findings (i.e., letters issues to recipients/complainants regarding the outcome of an OCR investigation) related to cases and/or compliance reviews involving FDA-funded recipients, as appropriate; and FDA/OEO, Office of the Commissioner will provide OCR with copies of any program site visit schedules for FDA recipients and copies of site visit reports, as appropriate.
Either FDA/OEO, Office of the Commissioner or DHHS/OCR may request amendments to this MOU and such amendments will be effective when FDA/OEO, Office of the Commissioner and DHHS/OCR concur in the proposed changes. After one year, FDA/OEO, Office of the Commissioner and DHHS/OCR will evaluate the terms contained in this MOU to determine if amendments are necessary.
Approved and Accepted
Signed by: Thomas E. Perez
Date: June 20, 2000
Approved and Accepted
Signed by: Jane E. Henney, M.D.
Date: June 27, 2000