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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Exemptions and Alternative Procedures

On November 24, 2004, the Food and Drug Administration published a final rule that includes requirements in 21 CFR Part 1271.155 for requesting an exemption from or alternative to any requirement in subpart C ( Donor Eligibility) or D ( Current Good Tissue Practices) of 21 CFR Part 1271. This rule was effective on May 25, 2005 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) procured on or after the effective date.

Requests for exemptions or alternative should be submitted to the Director of the appropriate Center.  CBER has redelegated the authority to issue a response to the Director and Deputy Director, Office of Cellular, Tissue and Gene Therapies.

If the HCT/P is regulated solely under 21 CFR Part 1271.10, as a biological product or as a medical device regulated by CBER, requests should be sent to:

Celia M. Witten, Ph.D., M.D.
Director, Office of Cellular, Tissue, and Gene Therapy
1401 Rockville Pike, HFM-775
Rockville, MD 20892

If you have questions concerning these requests or need to orally request an exemption or alternative, please contact Samuel Barone, M.D., Division of Human Tissues, Office of Cellular, Tissue, and Gene Therapies at 301-827-6040, or by FAX at 301-827-2844 or by email at Samuel.Barone@fda.hhs.gov.

If the HCT/P is regulated as a medical device by CDRH, the request should be sent to:

Director, Center for Devices and Radiological Health
c/o Director, Program Operations Staff
9200 Corporate Boulevard, HFZ-402
Rockville, MD 20850

If you have questions concerning these requests or need to orally request an exemption or alternative, please contact Mark N. Melkerson, Division of General Restorative, and Neurological Devices, Office of Device Evaluation at 301-594-1184, or by FAX at 301-594-2358 or by email at mark.melkerson@fda.hhs.gov.

Under 1271.155, the request must be accompanied by supporting documentation, including all relevant valid scientific data, and must contain either:

  1. Information justifying the requested exemption from the requirement, or
  2. A description of a proposed alternative method of meeting the requirement

Criteria for granting an exemption or alternative: The Director may grant an exemption or alternative if he or she finds that such action is consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases and that:

  1. The information submitted justifies and exemption; or
  2. The proposed alternative satisfies the purpose of the requirement

Form of Request: You must ordinarily make your request for an exemption or alternative in writing (hard copy or electronically). However, if circumstances make it difficult (e.g., there is inadequate time) to submit your request in writing, you may make the request orally, and the Director may orally grant an exemption or alternative. You must follow your oral request with an immediate written request, to which the Director will respond in writing.

Please also include the establishment Field Establishment Identifier (FEI) number if your establishment is registered with FDA and/or any other FDA regulatory submission number relevant to the HCT/P such as for an IND, IDE, BLA, PMA or 510(k).

Operation under exemption or alternative: You must not begin operating under the terms of a requested exemption or alternative until the exemption or alternative has been granted. You may apply for an extension of an exemption or alternative beyond its expiration date, if any.

Documentation: If you operate under the terms of an exemption or alternative, you must maintain documentation of:

  1. FDA's grant of the exemption or alternative, and
  2. The date on which you began operating under the terms of the exemption or alternative.

Issuance of an exemption or alternative by the Director: In a public health emergency, the Director may issue an exemption from, or alternative to, any requirement in part 1271. The Director may issue an exemption or alternative under this section if the exemption or alternative is necessary to assure that certain HCT/Ps will be available in a specified location to respond to an unanticipated immediate need for those HCT/Ps.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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