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 

mstockstill on DSK4VPTVN1PROD with NOTICES

51372 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

for termination of the recall to the 

appropriate FDA district office and wait 

for written FDA concurrence 

(§ 107.250). Where the recall strategy or 

implementation is determined to be 

deficient, FDA may require the firm to 

change the extent of the recall, carry out 

additional effectiveness checks, and 

issue additional notifications 

(§ 107.260). In addition, to facilitate 

location of the product being recalled, 

the recalling firm is required to 

maintain distribution records for at least 

1 year after the expiration of the shelf 

life of the infant formula (§ 107.280). 

The reporting and recordkeeping 

requirements described previously are 

designed to enable FDA to monitor the 

effectiveness of infant formula recalls in 

order to protect babies from infant 

formula that may be unsafe because of 

contamination or nutritional inadequacy 

or otherwise adulterated or misbranded. 

FDA uses the information collected 

under these regulations to help ensure 

that such products are quickly and 

efficiently removed from the market. 

In the Federal Register of June 7, 2011 

(76 FR 32976), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

No comments were received. 

FDA has added a new table 2 to this 

document to comply with the new 

requirement to report third-party 

disclosure burden hours in a separate 

table. The third-party disclosure burden 

hours were previously reported in the 

60-day notice under the reporting 

burden table (table 1). In compliance 

with the new requirement, we have 

broken out the third-party disclosure 

burden hours in a new third-party 

disclosure burden table (table 2). FDA 

has moved 50 hours per recall from line 

1 of table 1 to line 1 of table 2, and 25 

hours per recall from line 4 of table 1 

to line 2 of table 2. This is being done 

to show the third-party disclosure 

burden previously disclosed in table 1. 

The total estimated burden of this 

collection remains unchanged at 12,864 

hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of respondents 

Number of responses per respondent 

Total annual responses 

Average burden 

per response (in 

hours) 

Total hours 

107.230 ............................................................ 2 1 2 4,450 8,900 

107.240 ............................................................ 2 1 2 1,482 2,964 

107.250 ............................................................ 2 1 2 120 240 

107.260 2 .......................................................... 1 1 1 625 625 

Total .......................................................... ............................ ............................ ............................ ............................ 12,729 

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

2 No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine 

business practice. 

The reporting and third-party 

disclosure burden estimates are based 

on Agency records, which show that 

there are five manufacturers of infant 

formula and that there have been, on 

average, two infant formula recalls per 

year for the past 3 years. Based on this 

information, we estimate that there will 

be, on average, approximately two 

infant formula recalls per year over the 

next 3 years. 

Thus, FDA estimates that two 

respondents will conduct recalls 

annually under §§ 107.230, 107.240, and 

107.250. The estimated number of 

respondents for § 107.260 is minimal 

because this section is seldom used by 

FDA; therefore, the Agency estimates 

that there will be one or fewer 

respondents annually for § 107.260. 

The estimated number of reporting 

burden hours per response is an average 

based on the Agency’s experience and 

information from firms that have 

conducted recalls. We estimate that two 

respondents will conduct infant formula 

recalls under § 107.230 and that it will 

take a respondent 4,450 hours to comply 

with the requirements of that section, 

for a total of 8,900 hours. In the 60-day 

notice, we estimated that it will take a 

respondent 4,500 hours per recall to 

comply with § 107.230 for a total of 

9,000 hours. As noted, we have added 

a new table 2 to report third-party 

disclosure burden hours. The new lower 

figure of 4,450 hours per recall reflects 

that 50 hours are being reported in new 

table 2. We estimate that two 

respondents will conduct infant formula 

recalls under § 107.240 and that it will 

take a respondent 1,482 hours to comply 

with the requirements of that section, 

for a total of 2,964 hours. We estimate 

that two respondents will submit 

recommendations for termination of 

infant formula recalls under § 107.250 

and that it will take a respondent 120 

hours to comply with the requirements 

of that section, for a total of 240 hours. 

Finally, we estimate that one 

respondent will need to carry out 

additional effectiveness checks and 

issue additional notifications under 

§ 107.260, for a total of 625 hours. In the 

60-day notice, we estimated that it will 

take a respondent 650 hours per recall 

to comply with § 107.260 for a total of 

650 hours. As noted, we have added a 

new table 2 to report third-party 

disclosure burden hours. The new lower 

figure of 625 hours per recall reflects 

that 25 hours are being reported in new 

table 2. 

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. No 

burden has been estimated for the 

recordkeeping requirement in § 107.280 

because these records are maintained as 

a usual and customary part of normal 

business activities. Manufacturers keep 

infant formula distribution records for 

the prescribed period as a matter of 

routine business practice. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51373 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1

21 CFR Section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 

(in hours) 

Total hours 

107.230 ............................................................ 2 1 2 50 100 

107.260 ............................................................ 1 1 1 25 25 

Total .......................................................... ............................ ............................ ............................ ............................ 125 

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

New table 2 reports the Agency’s 

third-party disclosure burden estimates 

for §§ 107.230 and 107.260. The 

estimated burden hours per disclosure 

is an average based on the Agency’s 

experience. The third-party disclosure 

burden in § 107.230 is the requirement 

to promptly notify each affected directaccount (customer) about the recall and 

if the recalled formula presents a risk to 

human health, the requirement that the 

recalling firm must also request that 

each establishment that sells the 

recalled formula post (at the point of 

purchase) a notice of the recall. We 

estimate that two respondents will 

conduct infant formula recalls under 

§ 107.230 and that it will take a 

respondent 50 hours to comply with the 

third-party disclosure requirements of 

that section, for a total of 100 hours. The 

third-party disclosure burden in 

§ 107.260 is the requirement to issue 

additional notifications where the recall 

strategy or implementation is 

determined to be deficient. We estimate 

that one respondent will issue 

additional notifications under § 107.260 

and that it will take a respondent 25 

hours to comply with the third-party 

disclosure requirements of that section, 

for a total of 25 hours. 

Dated: August 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21040 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–0402] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Petitions for 

Exemption From Preemption 

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 0910–0277. 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. 

State Petitions for Exemption From 

Preemption—21 CFR 100.1(d) (OMB 

Control Number 0910–0277)—Extension 

Under section 403A(b) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 343–1(b)), States 

may petition FDA for exemption from 

Federal preemption of State food 

labeling and standard of identity 

requirements. Section 100.1(d) (21 CFR 

100.1(d)) sets forth the information a 

State is required to submit in such a 

petition. The information required 

under § 100.1(d) enables FDA to 

determine whether the State food 

labeling or standard of identity 

requirement satisfies the criteria of 

section 403A(b) of the FD&C Act for 

granting exemption from Federal 

preemption. 

In the Federal Register of June 10, 

2011 (76 FR 34082), 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 Number of 

respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

100.1(d) ................................................................................ 1 1 1 40 40 

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

The reporting burden for § 100.1(d) is 

minimal because petitions for 

exemption from preemption are seldom 

submitted by States. In the last 3 years, 

FDA has not received any new petitions 

for exemption from preemption; 

therefore, the Agency estimates that one 

or fewer petitions will be submitted 

annually. Although FDA has not 

received any new petitions for 

exemption from preemption in the last 

3 years, it believes these information 

collection provisions should be 

extended to provide for the potential 

future need of a State or local 

mstockstill on DSK4VPTVN1PROD with NOTICES