Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52055 

Agency identify and respond to 

emerging issues in a more timely 

manner. 

Dated: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24409 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–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 or we) 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 December 

11, 2017. 

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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 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 

for termination of the recall to the 

appropriate FDA district office and wait 

for FDA’s written 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, nutritional inadequacy, 

or is 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 15, 

2017 (82 FR 27509), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment that was unrelated to the 

information collection. 

FDA estimates the 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 an 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 an infant formula recall ................. 2 1 2 120 240 

107.260; Revision of an infant formula recall 2 .................... 1 1 1 625 625 


sradovich on DSK3GMQ082PROD with NOTICES
52056 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section/activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 2 ............................................................................ ........................ ........................ ........................ ........................ 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 FDA’s records, which show that 

there are six 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, FDA estimates 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 FDA seldom uses this section; 

therefore, FDA estimates that there will 

be one or fewer respondents annually 

for § 107.260. The estimated number of 

hours per response is an average based 

on FDA’s experience and information 

from firms that have conducted recalls. 

FDA estimates 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. FDA estimates 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. FDA 

estimates 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, FDA 

estimates that one 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 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

107.230; Elements of an infant formula recall ..................... 2 1 2 50 100 

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

Total 2 ............................................................................ ........................ ........................ ........................ ........................ 125 

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

Table 2 reports FDA’s third-party 

disclosure burden estimates for 

§§ 107.230 and 107.260. The estimated 

burden hours per disclosure is an 

average based on FDA’s experience. The 

third-party disclosure burden in 

§ 107.230 is the requirement to 

promptly notify each affected direct 

account (customer) about the recall, and 

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 a notice 

of the recall at the point of purchase. 

FDA estimates 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. FDA 

estimates 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: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24410 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Class II Special 

Controls Guidance Document: 

Labeling Natural Rubber Latex 

Condoms 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 


sradovich on DSK3GMQ082PROD with NOTICES