Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability, and Reporting Certain Changes to an Approved Application; Availability, 75483-75484 [2010-30388]

Download as PDF Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices Drug Products; Questions and Answers.’’ This document answers questions regarding CVM’s implementation of USP <467> Residual Solvents. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Significance of Guidance [Docket No. FDA–2009–D–0533] This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on this topic.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. Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability, and Reporting Certain Changes to an Approved Application; Availability III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.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 in this guidance have been approved under OMB control nos. 0910–0032 and 0910–0669. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access mstockstill on DSKH9S0YB1PROD with NOTICES Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: November 12, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–30387 Filed 12–2–10; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:09 Dec 02, 2010 Jkt 223001 Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application’’ dated November 2010. The guidance document provides recommendations to blood establishments for training of back-up personnel, assessment of blood donor suitability, and how to report certain changes to an approved license application to FDA. The guidance announced in this document finalizes the draft guidance entitled ‘‘Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus’’ dated November 2009. The guidance announced in this document also is superseding certain recommendations in two previous guidances, the guidance document entitled ‘‘Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture’’ dated July 2001 and the guidance document entitled ‘‘Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires’’ dated July 2003. DATES: Submit either electronic or written comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfSUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 75483 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 electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, 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 Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application’’ dated November 2010. The guidance document provides recommendations to blood establishments for training of back-up personnel, assessment of blood donor suitability, and reporting certain changes to an approved license application to FDA. In the Federal Register of November 19, 2009 (74 FR 59982), FDA announced the availability of the draft guidance entitled ‘‘Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus’’ (November 2009). At that time, we anticipated that the rapid spread of pandemic (H1N1) 2009 virus had the potential to cause disruptions in the blood supply and that the usual practices for ensuring blood availability in response to local disasters (i.e., hurricanes) would not be applicable or sufficient under a severe pandemic scenario. Since we issued the draft guidance, the H1N1 influenza pandemic has waned in the United States and disruptions in the blood supply have not been observed. Therefore, we are not finalizing those recommendations set forth in the draft guidance that referred to blood donor deferral and blood product management specific to the pandemic (H1N1) 2009 virus. Instead, we are finalizing those recommendations contained in the draft guidance that are of general E:\FR\FM\03DEN1.SGM 03DEN1 75484 Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices applicability (i.e., regardless of the existence of a pandemic or other emergency situation) as to training of back-up personnel, assessing blood donor suitability, and reporting certain changes to an approved application for licensed blood establishments. FDA received a few comments on the draft guidance in connection with these recommendations and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity. The guidance announced in this document finalizes the draft guidance dated November 2009. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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 requirements of the applicable statutes and regulations. Dated: November 24, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. II. Paperwork Reduction Act of 1995 Dated: November 29, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. 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 in 21 CFR part 606 have been approved under OMB control number 0910–0116. The collections of information for 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Comments mstockstill on DSKH9S0YB1PROD with NOTICES Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen 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/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. VerDate Mar<15>2010 16:09 Dec 02, 2010 Jkt 223001 [FR Doc. 2010–30388 Filed 12–2–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 13, 2010, 8 a.m. to December 13, 2010, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on November 17, 2010, 75 FR 70272–70273. The meeting will be held December 17, 2010. The meeting time and location remain the same. The meeting is closed to the public. [FR Doc. 2010–30343 Filed 12–2–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Musculoskeletal and Skin Sciences. Date: December 13–14, 2010. Time: 9 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting) Contact Person: Rajiv Kumar, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4122, MSC 7802, Bethesda, MD 20892. 301–435– 1212. kumarra@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Urology Small Business Applications. Date: December 14, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting) Contact Person: Ryan G. Morris, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 20892. 301–435– 1501. morrisr@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: HIV Pathogenesis, Therapy and NeuroAIDS. Date: December 15–16, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting) Contact Person: Shiv A Prasad, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892. 301–443– 5779. prasads@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 29, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–30342 Filed 12–2–10; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75483-75484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30388]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0533]


Guidance for Industry: Recommendations for Blood Establishments: 
Training of Back-Up Personnel, Assessment of Blood Donor Suitability, 
and Reporting Certain Changes to an Approved Application; 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: 
Recommendations for Blood Establishments: Training of Back-Up 
Personnel, Assessment of Blood Donor Suitability and Reporting Certain 
Changes to an Approved Application'' dated November 2010. The guidance 
document provides recommendations to blood establishments for training 
of back-up personnel, assessment of blood donor suitability, and how to 
report certain changes to an approved license application to FDA. The 
guidance announced in this document finalizes the draft guidance 
entitled ``Draft Guidance for Industry: Recommendations for the 
Assessment of Blood Donor Suitability, Blood Product Safety, and 
Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 
Virus'' dated November 2009. The guidance announced in this document 
also is superseding certain recommendations in two previous guidances, 
the guidance document entitled ``Guidance for Industry: Changes to an 
Approved Application: Biological Products: Human Blood and Blood 
Components Intended for Transfusion or for Further Manufacture'' dated 
July 2001 and the guidance document entitled ``Guidance for Industry: 
Streamlining the Donor Interview Process: Recommendations for Self-
Administered Questionnaires'' dated July 2003.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, 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 electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, 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 Blood Establishments: 
Training of Back-Up Personnel, Assessment of Blood Donor Suitability 
and Reporting Certain Changes to an Approved Application'' dated 
November 2010. The guidance document provides recommendations to blood 
establishments for training of back-up personnel, assessment of blood 
donor suitability, and reporting certain changes to an approved license 
application to FDA.
    In the Federal Register of November 19, 2009 (74 FR 59982), FDA 
announced the availability of the draft guidance entitled ``Draft 
Guidance for Industry: Recommendations for the Assessment of Blood 
Donor Suitability, Blood Product Safety, and Preservation of the Blood 
Supply in Response to Pandemic (H1N1) 2009 Virus'' (November 2009). At 
that time, we anticipated that the rapid spread of pandemic (H1N1) 2009 
virus had the potential to cause disruptions in the blood supply and 
that the usual practices for ensuring blood availability in response to 
local disasters (i.e., hurricanes) would not be applicable or 
sufficient under a severe pandemic scenario. Since we issued the draft 
guidance, the H1N1 influenza pandemic has waned in the United States 
and disruptions in the blood supply have not been observed. Therefore, 
we are not finalizing those recommendations set forth in the draft 
guidance that referred to blood donor deferral and blood product 
management specific to the pandemic (H1N1) 2009 virus. Instead, we are 
finalizing those recommendations contained in the draft guidance that 
are of general

[[Page 75484]]

applicability (i.e., regardless of the existence of a pandemic or other 
emergency situation) as to training of back-up personnel, assessing 
blood donor suitability, and reporting certain changes to an approved 
application for licensed blood establishments. FDA received a few 
comments on the draft guidance in connection with these recommendations 
and those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this document finalizes the draft guidance dated November 
2009.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements 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 in 21 CFR part 606 have been approved under 
OMB control number 0910-0116. The collections of information for 21 CFR 
part 601 have been approved under OMB control number 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30388 Filed 12-2-10; 8:45 am]
BILLING CODE 4160-01-P
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