Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma, 24720-24721 [2012-9894]

Download as PDF 24720 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices of competitive applications following initial review of applications received in response to ‘‘FOA CE12–001, Grants for Injury Control Research Centers (R49).’’ Contact Person for More Information: Christine Morrison, Ph.D., Director, Extramural Research Program Office, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway, NE., Mailstop F63, Atlanta, Georgia 30341–3724, Telephone (770) 488–4233. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: April 18, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–9935 Filed 4–24–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ ATSDR) pmangrum on DSK3VPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee: Times and Dates: 8:30 a.m.–4:30 p.m., May 17, 2012. 8:30 a.m.–12:15 p.m., May 18, 2012. Place: CDC, 4770 Buford Highway, Atlanta, Georgia 30341. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. Purpose: The Secretary, Department of Health and Human Services (HHS) and by delegation, the Director, CDC and Administrator, NCEH/ATSDR, are authorized under Section 301 (42 U.S.C. 241) and Section 311 (42 U.S.C. 243) of the Public Health Service Act, as amended, to: (1) Conduct, encourage, cooperate with, and assist other appropriate public authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments; (2) assist states and their political subdivisions in the prevention of infectious diseases and other preventable conditions and in the promotion of health and well being; and (3) train state and local personnel in health VerDate Mar<15>2010 15:14 Apr 24, 2012 Jkt 226001 work. The BSC, NCEH/ATSDR provides advice and guidance to the Secretary, HHS; the Director, CDC and Administrator, ATSDR; and the Director, NCEH/ATSDR, regarding program goals, objectives, strategies, and priorities in fulfillment of the agency’s mission to protect and promote people’s health. The board provides advice and guidance that will assist NCEH/ATSDR in ensuring scientific quality, timeliness, utility, and dissemination of results. The board also provides guidance to help NCEH/ ATSDR work more efficiently and effectively with its various constituents and to fulfill its mission in protecting America’s health. Matters to be Discussed: The agenda items for the BSC Meeting on May 17–18, 2012 will include NCEH/ATSDR Office of the Director updates: ATSDR and NCEH Reorganization; update on the Nutritional Biomarker Report: Transfat analysis; ATSDR Science Symposium recommendations; presentation on Environmental Health Exposure Investigations; update on the Advisory Committee on Childhood Lead Poisoning Prevention; and updates by the BSC Federal Experts. Agenda items are subject to change as priorities dictate. Supplementary Information: The public comment period is scheduled on Thursday, May 17, 2012 from 3 p.m. until 3:15 p.m., and Friday, May 18, 2012 from 10:45 a.m. until 11 a.m. Contact Person for More Information: Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, 4770 Buford Highway, Mail Stop F–61, Chamblee, Georgia 30345; telephone (770) 488–0575, Fax: (770) 488–3377; email: smalcom@cdc.gov. The deadline for notification of attendance is May 11, 2012. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: April 18, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–9925 Filed 4–24–12; 8:45 am] Funding Opportunity Announcement (FOA) GH12–007, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: DATES: Time and Date: 1 p.m.–4 p.m., June 20, 2012 (Closed). PLACE: Teleconference. STATUS: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92– 463. MATTERS TO BE DISCUSSED: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Conducting Operational Research to Measure or Mitigate Morbidity and Mortality of Populations Affected by Humanitarian Emergencies, FOA GH12– 007.’’ CONTACT PERSON FOR MORE INFORMATION: Diana Bartlett, Scientific Review Officer, Office of the Associate Director for Science, Office of Science Quality, CDC, 1600 Clifton Road NE., Mailstop D–72, Atlanta, Georgia 30033, Telephone (404) 639–4938. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: April 25, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–9924 Filed 4–24–12; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The meeting announced below concerns Conducting Operational Research to Measure or Mitigate Morbidity and Mortality of Populations Affected by Humanitarian Emergencies, PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0827] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma AGENCY: Food and Drug Administration, HHS. E:\FR\FM\25APN1.SGM 25APN1 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by May 25, 2012. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–New and title ‘‘Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: ≤Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. pmangrum on DSK3VPTVN1PROD with NOTICES SUMMARY: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma—(OMB Control Number 0910–NEW) FDA is finalizing the labeling requirements for blood or blood components intended for use in transfusion or for further manufacture under the provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262–264), and the drugs, devices, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 351– 353, 355, 360, 360j, 371, and 374). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, potent, and properly labeled, and to prevent the introduction, transmission, and spread of communicable disease. Under this rulemaking, FDA is consolidating the regulations related to labeling blood and blood components. Regulations for labeling of blood and blood components will be consolidated VerDate Mar<15>2010 15:14 Apr 24, 2012 Jkt 226001 into § 606.121 (Container label) (21 CFR 606.121) and § 606.122 (Circular of information) (21 CFR 606.122). This notice solicits comments on the information collection associated with § 606.121(c)(11), which requires that if the product is intended for further manufacturing use, a statement listing the results of all the tests for communicable disease agents required under § 610.40 (21 CFR 610.40) for which the donation has been tested and found negative must be on the container label; except that the label for Source Plasma is not required to list the negative results of serological syphilis testing under § 610.40(i) and 21 CFR 640.65(b). In addition, this notice also solicits comments on the information collection associated with § 606.121(e)(2)(i), which requires that the product labels of certain red blood cells must include the type of additive solution with which the product was prepared. The Agency believes the rule amendments and the information collection provisions under § 606.121(c)(11) and (e)(2)(i) in the final rule are part of usual and customary business practice and do not create any new burden for respondent. The collection of information requirements under §§ 606.121 and 606.122 are approved under OMB control number 0910–0116 and those in 21 CFR 640.70 have been approved under OMB control number 0910–0338. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. In the Federal Register of December 30, 2011 (76 FR 82300), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. Dated: April 19, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–9894 Filed 4–24–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 24721 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] The 15th Annual Food and Drug Administration—Orange County Regulatory Affairs Educational Conference in Irvine, CA; ‘‘Sustainable Regulatory Practices’’ AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing the following conference: The 15th Annual Educational Conference cosponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive Q & A, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues. Date and Time: The conference will be held on June 6 and 7, 2012, from 7:30 a.m. to 5 p.m. Location: The conference will be held at the Irvine Marriott, 18000 Von Karman Ave., Irvine, CA 92612. Contact: Linda Hartley, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949–608–4413, Fax: 949–608–4417, or OCRA, Attention to Detail, 5319 University Dr., suite 641, Irvine, CA 92612, 949–387–9046, Fax: 949–266–8461, Web site: www.ocradg.org. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register). Registration and Meeting Information: See OCRA Web site, www.ocra-dg.org. Contact Attention to Detail, 949–387– 9046. Before May 8, 2012, registration fees are as follows: $675 for members, $725 for non-members and $475 for FDA/ Government/Students.1 After May 8, 2012, fees will be $725 for members, $775 for non-members, and $475 for 1 OCRA Student Rate applies to those individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. Proof of enrollment is required. Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24720-24721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9894]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0827]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Revisions to Labeling 
Requirements for Blood and Blood Components, Including Source Plasma

AGENCY: Food and Drug Administration, HHS.

[[Page 24721]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 25, 
2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Revisions to Labeling Requirements for Blood and Blood 
Components, Including Source Plasma.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: >Ila S. Mizrachi, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Revisions to Labeling Requirements for Blood and Blood Components, 
Including Source Plasma--(OMB Control Number 0910-NEW)

    FDA is finalizing the labeling requirements for blood or blood 
components intended for use in transfusion or for further manufacture 
under the provisions of the Public Health Service Act (PHS Act) (42 
U.S.C. 262-264), and the drugs, devices, and general administrative 
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374). Under these 
provisions of the PHS Act and the FD&C Act, we have the authority to 
issue and enforce regulations designed to ensure that biological 
products are safe, pure, potent, and properly labeled, and to prevent 
the introduction, transmission, and spread of communicable disease.
    Under this rulemaking, FDA is consolidating the regulations related 
to labeling blood and blood components. Regulations for labeling of 
blood and blood components will be consolidated into Sec.  606.121 
(Container label) (21 CFR 606.121) and Sec.  606.122 (Circular of 
information) (21 CFR 606.122). This notice solicits comments on the 
information collection associated with Sec.  606.121(c)(11), which 
requires that if the product is intended for further manufacturing use, 
a statement listing the results of all the tests for communicable 
disease agents required under Sec.  610.40 (21 CFR 610.40) for which 
the donation has been tested and found negative must be on the 
container label; except that the label for Source Plasma is not 
required to list the negative results of serological syphilis testing 
under Sec.  610.40(i) and 21 CFR 640.65(b). In addition, this notice 
also solicits comments on the information collection associated with 
Sec.  606.121(e)(2)(i), which requires that the product labels of 
certain red blood cells must include the type of additive solution with 
which the product was prepared.
    The Agency believes the rule amendments and the information 
collection provisions under Sec.  606.121(c)(11) and (e)(2)(i) in the 
final rule are part of usual and customary business practice and do not 
create any new burden for respondent.
    The collection of information requirements under Sec. Sec.  606.121 
and 606.122 are approved under OMB control number 0910-0116 and those 
in 21 CFR 640.70 have been approved under OMB control number 0910-0338. 
Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources 
necessary to comply with a collection of information are excluded from 
the burden estimate if the reporting, recordkeeping, or disclosure 
activities needed to comply are usual and customary because they would 
occur in the normal course of activities.
    In the Federal Register of December 30, 2011 (76 FR 82300), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

    Dated: April 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9894 Filed 4-24-12; 8:45 am]
BILLING CODE 4160-01-P

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