Agency Emergency Processing Under the Office of Management and Budget Review; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Withdrawal, 9083 [05-3596]

Download as PDF Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. 2005D–0056] [Docket No. 2003D–0386] Agency Emergency Processing Under the Office of Management and Budget Review; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is withdrawing a notice that published in the Federal Register on January 26, 2005 (70 FR 3712). SUMMARY: This notice is withdrawn on February 24, 2005. DATES: FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1482. In the Federal Register of January 26, 2005, FDA published a notice informing interested parties that the proposed collection of information entitled ‘‘Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice’’ had been submitted to the Office of Management and Budget (OMB) for processing in compliance with (44 U.S.C. 3507(j), of the Paperwork Reduction Act of 1995 and 5 CFR 1320.13). The notice contains a number of errors. Therefore, we are withdrawing both the notice itself and the request for OMB approval of the proposed collection of information. SUPPLEMENTARY INFORMATION: Dated: February 17, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–3596 Filed 2–23–05; 8:45 am] VerDate jul<14>2003 18:49 Feb 23, 2005 Jkt 205001 AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. BILLING CODE 4160–01–S Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),’’ dated November 2004. The guidance document provides medical device manufacturers with information about performing studies to support modifying the indication for use of communicable disease tests to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance document recommends a suggested protocol to modify the indication for use to include testing of cadaveric blood specimens. DATES: Submit written or electronic comments on agency guidances at any time. In accordance with 21 CFR 10.115(g)(4)(i), FDA is immediately implementing this guidance. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling the CBER Voice Information System at 1–800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 9083 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Kathleen E. Swisher, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),’’ dated November 2004. The guidance document provides information to medical device manufacturers of communicable disease tests used to screen donors of HCT/Ps for communicable diseases who plan to perform studies to validate the use of cadaveric blood specimens with their tests. The guidance supercedes the May 2, 1995, letter issued by FDA to manufacturers of communicable disease tests suggesting a minimum protocol for validation of use of cadaveric blood specimens with their donor screening tests. The guidance recommends a minimum suggested protocol to validate an indication for use of cadaveric blood specimens with communicable disease tests used to screen donors of HCT/Ps. The guidance makes recommendations about: (1) Sensitivity and specificity studies, (2) reproducibility studies, (3) number of test kit lots to include in studies, (4) plasma dilution issues, and (5) information about specimen collection times to be included. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Notices]
[Page 9083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3596]



[[Page 9083]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0386]


Agency Emergency Processing Under the Office of Management and 
Budget Review; Draft Guidance for Industry on Formal Dispute 
Resolution: Scientific and Technical Issues Related to Pharmaceutical 
Current Good Manufacturing Practice; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a notice 
that published in the Federal Register on January 26, 2005 (70 FR 
3712).

DATES: This notice is withdrawn on February 24, 2005.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 26, 2005, 
FDA published a notice informing interested parties that the proposed 
collection of information entitled ``Draft Guidance for Industry on 
Formal Dispute Resolution: Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice'' had been submitted 
to the Office of Management and Budget (OMB) for processing in 
compliance with (44 U.S.C. 3507(j), of the Paperwork Reduction Act of 
1995 and 5 CFR 1320.13). The notice contains a number of errors. 
Therefore, we are withdrawing both the notice itself and the request 
for OMB approval of the proposed collection of information.

    Dated: February 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3596 Filed 2-23-05; 8:45 am]
BILLING CODE 4160-01-S