23732 Federal Register / Vol. 77, No. 77 / Friday, April 20, 2012 / Notices 

Dated: April 16, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9533 Filed 4–19–12; 8:45 am] 

BILLING CODE 4160–01–P 

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 http://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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0369] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations Under 

the Federal Import Milk Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 http:// 

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 

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 


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