Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 63127 

Dated: October 17, 2014. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2014–25133 Filed 10–17–14; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1027] 

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 November 

21, 2014. 

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 0910–0188. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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. 

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.’’ Our 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 us 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 

for termination of the recall to the 

appropriate FDA district office and wait 

for our written concurrence (§ 107.250). 

Where the recall strategy or 

implementation is determined to be 

deficient, we 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 us 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. 

We use 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 August 7, 

2014 (79 FR 46270), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the annual burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

107.230; elements of infant formula recall ...... 2 1 2 4,450 8,900 

107.240; notification requirements ................... 2 1 2 1,482 2,964 

107.250; termination of infant formula recall ... 2 1 2 120 240 

107.260; revision of an infant formula recall 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. 

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63128 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 

The reporting and third-party 

disclosure burden estimates are based 

on our records, which show that there 

are 5 manufacturers of infant formula 

and that there have been, on average, 2 

infant formula recalls per year for the 

past 3 years. Based on this information, 

we estimate that there will be, on 

average, approximately 2 infant formula 

recalls per year over the next 3 years. 

Thus, we estimate that 2 respondents 

will conduct recalls annually pursuant 

to §§ 107.230, 107.240, and 107.250. 

The estimated number of respondents 

for § 107.260 is minimal because we 

seldom use this section; therefore, we 

estimate that there will be 1 or fewer 

respondents annually for § 107.260. The 

estimated number of hours per response 

is an average based on our experience 

and information from firms that have 

conducted recalls. We estimate that 2 

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. We estimate 

that 2 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 2 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 1 respondent 

will need to carry out additional 

effectiveness checks and issue 

additional notifications, for a total of 

625 hours. 

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. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

107.230; elements of infant formula recall ...... 2 1 2 50 100 

107.260; revision of an infant formula recall ... 1 1 1 25 25 

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

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

Table 2 reports our third-party 

disclosure burden estimates for 

§§ 107.230 and 107.260. The estimated 

burden hours per disclosure is an 

average based on our 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 a notice of the 

recall at the point of purchase. We 

estimate that 2 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 1 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: October 16, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25105 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1104] 

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 November 

21, 2014. 

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 0910–0277. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd.; COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

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. 

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 

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