Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”, 23732 [2012-9531]

Download as PDF 23732 Federal Register / Vol. 77, No. 77 / Friday, April 20, 2012 / Notices Dated: April 16, 2012. Leslie Kux, Assistant Commissioner for Policy. Dated: April 16, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–9533 Filed 4–19–12; 8:45 am] [FR Doc. 2012–9531 Filed 4–19–12; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2012–N–0369] [Docket No. FDA–2011–N–0511] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ‘‘Lookback’’ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ‘ Lookback’ ’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: 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. FOR FURTHER INFORMATION CONTACT: On January 3, 2012, the Agency submitted a proposed collection of information entitled ‘‘Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ‘Lookback’ ’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0116. The approval expires on April 30, 2015. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. tkelley on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:17 Apr 19, 2012 Jkt 226001 Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements of FDA’s regulations implementing the Federal Import Milk Act (FIMA). DATES: Submit either electronic or written comments on the collection of information by June 19, 2012. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400T, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Regulations Under the Federal Import Milk Act—21 CFR Part 1210 (OMB Control Number 0910–0212)—Extension Under FIMA (21 U.S.C. 141–149), milk or cream may be imported into the United States only by the holder of a valid import milk permit (21 U.S.C. 141). Before such permit is issued: (1) All cows from which import milk or cream is produced must be physically examined and found healthy; (2) if the milk or cream is imported raw, all such cows must pass a tuberculin test; (3) the dairy farm and each plant in which the milk or cream is processed or handled must be inspected and found to meet certain sanitary requirements; (4) bacterial counts of the milk at the time of importation must not exceed specified limits; and (5) the temperature of the milk or cream at time of importation must not exceed 50° F (21 U.S.C. 142). FDA’s regulations in part 1210 (21 CFR part 1210) implement the provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the sanitary conditions of, respectively, dairy farms and plants producing milk and/or cream to be shipped to the United States. Section 1210.12 requires E:\FR\FM\20APN1.SGM 20APN1

Agencies

[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Page 23732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9531]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0511]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Current Good Manufacturing Practices 
and Related Regulations for Blood and Blood Components; and 
Requirements for Donor Testing, Donor Notification, and ``Lookback''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Current Good Manufacturing 
Practices and Related Regulations for Blood and Blood Components; and 
Requirements for Donor Testing, Donor Notification, and ` Lookback' '' 
has been approved by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995.

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: On January 3, 2012, the Agency submitted a 
proposed collection of information entitled ``Current Good 
Manufacturing Practices and Related Regulations for Blood and Blood 
Components; and Requirements for Donor Testing, Donor Notification, and 
`Lookback' '' to OMB for review and clearance under 44 U.S.C. 3507. An 
Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has now approved the information 
collection and has assigned OMB control number 0910-0116. The approval 
expires on April 30, 2015. A copy of the supporting statement for this 
information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: April 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9531 Filed 4-19-12; 8:45 am]
BILLING CODE 4160-01-P
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