51370 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Assisted Household Report—Long Form ........................................................ 52 1 25 1,300 

Assisted Household Report—Short Form ....................................................... 164 1 1 164 

Applicant Household Report ............................................................................ 52 1 13 676 

Estimated Total Annual Burden 

Estimates: 2,140. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–6974, Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–21107 Filed 8–17–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0424] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Temporary 

Marketing Permit Applications 

AGENCY: Food and Drug Administration, 

HHS. 

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 September 

19, 2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0133. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Temporary Marketing Permit 

Applications—21 CFR 130.17(c) and 

(i)—(OMB Control Number 0910– 

0133)—Extension 

Section 401 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 341) directs FDA to issue 

regulations establishing definitions and 

standards of identity for food 

‘‘[w]henever * * * such action will 

promote honesty and fair dealing in the 

interest of consumers * * *.’’ Under 

section 403(g) of the FD&C Act (21 

U.S.C. 343(g)), a food that is subject to 

a definition and standard of identity 

prescribed by regulation is misbranded 

if it does not conform to such definition 

and standard of identity. Section 130.17 

(§ 130.17) provides for the issuance by 

FDA of temporary marketing permits 

that enable the food industry to test 

consumer acceptance and measure the 

technological and commercial feasibility 

in interstate commerce of experimental 

packs of food that deviate from 

applicable definitions and standards of 

identity. Section 130.17(c) enables the 

Agency to monitor the manufacture, 

labeling, and distribution of 

experimental packs of food that deviate 

from applicable definitions and 

standards of identity. The information 

so obtained can be used in support of 

a petition to establish or amend the 

applicable definition or standard of 

identity to provide for the variations. 

Section 130.17(i) specifies the 

information that a firm must submit to 

FDA to obtain an extension of a 

temporary marketing permit. 

In the Federal Register of June 10, 

2011 (76 FR 34080), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of respondents 

No. of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

130.17(c) .............................................................................. 13 2 26 25 650 

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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51371 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section No. of respondents 

No. of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

130.17(i) ............................................................................... 1 2 2 2 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 654 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The estimated number of temporary 

marketing permit applications and 

hours per response is an average based 

on the Agency’s experience with 

applications received for the past 3 

years, and information from firms that 

have submitted recent requests for 

temporary marketing permits. Based on 

this information, we estimate that there 

will be, on average, approximately 13 

firms submitting requests for two 

temporary marketing permits per year 

over the next 3 years. 

Thus, FDA estimates that 13 

respondents will submit 2 requests for 

temporary marketing permits annually 

under § 130.17(c). The estimated 

number of respondents for § 130.17(i) is 

minimal because this section is seldom 

used by the respondents; therefore, the 

Agency estimates that there will be one 

or fewer respondents annually with two 

or fewer requests for extension of the 

marketing permit under § 130.17(i). The 

estimated number of hours per response 

is an average based on the Agency’s 

experience and information from firms 

that have submitted recent requests for 

temporary marketing permits. We 

estimate that 13 respondents each will 

submit 2 requests for temporary 

marketing permits under § 130.17(c) and 

that it will take a respondent 25 hours 

per request to comply with the 

requirements of that section, for a total 

of 650 hours. We estimate that one 

respondent will submit two requests for 

extension of its temporary marketing 

permits under § 130.17(i) and that it will 

take a respondent 2 hours per request to 

comply with the requirements of that 

section, for a total of 4 hours. 

Dated: August 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21039 Filed 8–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0425] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Infant Formula 

Recall Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

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 September 

19, 2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0188. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Infant Formula Recall Regulations—21 

CFR 107.230, 107.240, 107.250, 107.260, 

and 107.280—(OMB Control Number 

0910–0188)—Extension 

Section 412(e) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 350a(e)) provides that if the 

manufacturer of an infant formula has 

knowledge that reasonably supports the 

conclusion that an infant formula 

processed by that manufacturer has left 

its control and may not provide the 

nutrients required in section 412(i) of 

the FD&C Act or is otherwise 

adulterated or misbranded, the 

manufacturer must promptly notify the 

Secretary of Health and Human Services 

(the Secretary). If the Secretary 

determines that the infant formula 

presents a risk to human health, the 

manufacturer must immediately take all 

actions necessary to recall shipments of 

such infant formula from all wholesale 

and retail establishments, consistent 

with recall regulations and guidelines 

issued by the Secretary. Section 

412(f)(2) of the FD&C Act states that the 

Secretary shall by regulation prescribe 

the scope and extent of recalls of infant 

formula necessary and appropriate for 

the degree of risk to human health 

presented by the formula subject to 

recall. FDA’s infant formula recall 

regulations in part 107 (21 CFR part 

107) implement these statutory 

provisions. 

Section 107.230 requires each 

recalling firm to conduct an infant 

formula recall with the following 

elements: (1) Evaluate the hazard to 

human health, (2) devise a written recall 

strategy, (3) promptly notify each 

affected direct-account (customer) about 

the recall, and (4) furnish the 

appropriate FDA district office with 

copies of these documents. If the 

recalled formula presents a risk to 

human health, the recalling firm must 

also request that each establishment that 

sells the recalled formula post (at point 

of purchase) a notice of the recall and 

provide FDA with a copy of the notice. 

Section 107.240 requires the recalling 

firm to conduct an infant formula recall 

with the following elements: (1) Notify 

the appropriate FDA district office of 

the recall by telephone within 24 hours, 

(2) submit a written report to that office 

within 14 days, and (3) submit a written 

status report at least every 14 days until 

the recall is terminated. Before 

terminating a recall, the recalling firm is 

required to submit a recommendation 

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