Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments; Availability, 61780-61781 [E6-17378]

Download as PDF 61780 Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices further rounding upwards to the nearest 50 hours). 3. Estimated Cost Burden The cost per participant should be negligible. Participation is voluntary, and will not require any start-up, capital, or labor expenditures by study participants. As with the initial study, participants will not pay for their credit reports or credit scores. William Blumenthal, General Counsel. [FR Doc. E6–17507 Filed 10–18–06; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS–0990–0304; 30 day notice] Agency Information Collection Activities: Proposed Collection; Comment Request Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Type of Information Collection Request: Regular Clearance, Extension of a currently approved collection. Title of Information Collection: National Outcomes Performance Assessment of the Collaborative Initiative to Help End Chronic Homelessness. Form/OMB No.: OS–0990–0304. Use: The goals of this 3-year program for persons experiencing chronic homelessness include: (1) Increase the effectiveness of integrated systems of care for chronically homeless persons by providing comprehensive services and treatment and linking them to cprice-sewell on PROD1PC66 with NOTICES AGENCY: VerDate Aug<31>2005 14:50 Oct 18, 2006 Jkt 211001 housing; (2) create additional permanent housing for chronically homeless persons; (3) increase the use of underused mainstream resources that pay for services and treatment for chronically homeless persons (e.g., Medicaid, TANF, Food Stamps, block grants, state-funded children’s health insurance programs); (4) replicate service, treatment, and housing models known to be effective based on sound evidence; and, (5) support the development of infrastructures that sustain the housing, services, treatments, and inter-organizational partnerships beyond the 3-year Initiative. Frequency: Reporting, on occasion, quarterly, annually. Affected Public: Individuals or Households. Annual Number of Respondents: 723. Total Annual Responses: 1857. Average Burden per Response: .9. Total Annual Hours: 1857. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access the HHS Web site address at https://www.hhs.gov/ocio/ infocollect/pending/ or e-mail your request, including your address, phone number, OMB number, and OS document identifier, to Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on (202) 690–6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990–0304), New Executive Office Building, Room 10235, Washington DC 20503. Dated: October 11, 2006. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E6–17424 Filed 10–18–06; 8:45 am] BILLING CODE 4150–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2001D–0220 (Formally Docket No. 01D–0220)] Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments; Availability AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments,’’ dated October 2006. The guidance provides blood and plasma establishments, including licensed blood establishments, unlicensed registered blood establishments, and transfusion services, with the FDA’s current thinking related to the biological product deviation reporting requirements. The guidance document will assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The guidance finalizes the draft guidance document under the same title dated August 2001. DATES: Submit written or electronic comments on agency guidances at any time. 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, suite 200N, 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 CBER 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. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., 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: Biological Product Deviation Reporting for Blood and Plasma Establishments’’ dated October 2006. The guidance is intended to provide E:\FR\FM\19OCN1.SGM 19OCN1 Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices cprice-sewell on PROD1PC66 with NOTICES assistance to blood and plasma establishments in the reporting of any event associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of blood or blood components that may effect the safety, purity, or potency of a distributed product as required under §§ 600.14 and 606.171 (21 CFR 600.14 and 606.171). The guidance provides additional information regarding the regulations in § 606.171 by describing who must report, what must be included in the report, when the establishment must report, and how to report either electronically or by mail using Form FDA–3486, a standardized reporting format. Examples of reportable and non-reportable events concerning donor suitability, product collection, component preparation, testing, labeling, quality control and distribution are discussed. The guidance also contains a Biological Product Deviation Reporting Flow Chart to aid the blood or plasma establishment in determining if an event is reportable. In the Federal Register of August 13, 2001 (66 FR 42546) FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated August 2001. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the FDA’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 requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information under § 606.171 and 21 CFR 606.100 were approved under OMB control number 0910–0116. The collection of information under § 600.14 was approved under OMB control number 0910–0139. The collections of information under 21 CFR 820.90 and 820.100 were approved under OMB control number 0910–0458. The VerDate Aug<31>2005 14:50 Oct 18, 2006 Jkt 211001 collections of information under 21 CFR 211.192 and 211.198 were approved under OMB control number 0910–0139. III. 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 that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. Dated: October 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–17378 Filed 10–18–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2001D–0221 (Formally Docket No. 01D–0221)] Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components,’’ dated October 2006. The guidance document provides licensed manufacturers of biological products other than blood and blood components with the FDA’s current thinking related to the biological product deviation reporting requirements. The guidance document will assist the licensed manufacturers of biological products other than blood and blood components PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 61781 in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. This guidance finalizes the draft guidance document of the same title dated August 2001. DATES: Submit written or electronic comments on agency guidances at any time. 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, suite 200N, 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 CBER 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. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., 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: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components,’’ dated October 2006. The guidance is intended to provide assistance to licensed manufacturers of biological products other than blood and blood components in the reporting of any event associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution of a licensed biological product which may affect the safety, purity, or potency of a distributed licensed product as required under § 600.14 (21 CFR 600.14). The guidance provides additional information regarding the regulations in § 600.14, which describe who must report, what must be included in the report, when the licensed manufacturer must report, and provides that the licensed E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61780-61781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17378]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0220 (Formally Docket No. 01D-0220)]


Guidance for Industry: Biological Product Deviation Reporting for 
Blood and Plasma Establishments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Biological 
Product Deviation Reporting for Blood and Plasma Establishments,'' 
dated October 2006. The guidance provides blood and plasma 
establishments, including licensed blood establishments, unlicensed 
registered blood establishments, and transfusion services, with the 
FDA's current thinking related to the biological product deviation 
reporting requirements. The guidance document will assist blood and 
plasma establishments in determining when a report is required, who 
submits the report, what information to submit in the report, the 
timeframe for reporting, and how to submit the report. The guidance 
finalizes the draft guidance document under the same title dated August 
2001.

DATES: Submit written or electronic comments on agency guidances at any 
time.

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, suite 200N, 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 CBER 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. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., 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: Biological Product Deviation Reporting for 
Blood and Plasma Establishments'' dated October 2006. The guidance is 
intended to provide

[[Page 61781]]

assistance to blood and plasma establishments in the reporting of any 
event associated with the manufacturing, to include testing, 
processing, packing, labeling, or storage, or with the holding or 
distribution, of blood or blood components that may effect the safety, 
purity, or potency of a distributed product as required under 
Sec. Sec.  600.14 and 606.171 (21 CFR 600.14 and 606.171). The guidance 
provides additional information regarding the regulations in Sec.  
606.171 by describing who must report, what must be included in the 
report, when the establishment must report, and how to report either 
electronically or by mail using Form FDA-3486, a standardized reporting 
format. Examples of reportable and non-reportable events concerning 
donor suitability, product collection, component preparation, testing, 
labeling, quality control and distribution are discussed. The guidance 
also contains a Biological Product Deviation Reporting Flow Chart to 
aid the blood or plasma establishment in determining if an event is 
reportable.
    In the Federal Register of August 13, 2001 (66 FR 42546) FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. Editorial changes were made 
to improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated August 2001.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the FDA'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 
requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information under Sec.  606.171 and 21 CFR 606.100 were 
approved under OMB control number 0910-0116. The collection of 
information under Sec.  600.14 was approved under OMB control number 
0910-0139. The collections of information under 21 CFR 820.90 and 
820.100 were approved under OMB control number 0910-0458. The 
collections of information under 21 CFR 211.192 and 211.198 were 
approved under OMB control number 0910-0139.

III. 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 that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in the brackets in the heading of this document. A copy of 
the guidance and received comments are available for public examination 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: October 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-17378 Filed 10-18-06; 8:45 am]
BILLING CODE 4160-01-S

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