Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52053 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–D–2300 for ‘‘Evaluating Drug 

Effects on the Ability to Operate a Motor 

Vehicle.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Naomi Lowy, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4204, 

Silver Spring, MD 20993–0002, 301– 

796–0692. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Evaluating Drug Effects on the Ability 

to Operate a Motor Vehicle.’’ The 

purpose of this guidance is to assist 

sponsors in the evaluation of the effects 

of psychoactive drugs on the ability to 

operate a motor vehicle. 

Driving is a complex activity 

involving a wide range of cognitive, 

perceptual, and motor activities that can 

be adversely affected by therapeutic 

drugs. Reducing the incidence of MVAs 

that occur because of drug-impaired 

driving is a public health priority. 

Drugs that impair driving ability may 

also impair an individual’s ability to 

judge the extent of his or her own 

impairment. This increases the need for 

objective evaluation of the presence and 

degree of driving impairment, with risk 

mitigation strategies based on that 

information. This guidance recommends 

a systematic effort to identify drugs for 

which evaluation of effects on driving 

abilities may be needed and the types of 

studies that such an evaluation entails. 

This guidance finalizes the draft 

guidance issued on January 16, 2015, 

(80 FR 2432) of the same name. Changes 

made to the guidance took into 

consideration comments received. In 

addition to editorial changes made 

primarily for clarification, the guidance 

provides multiple areas of clarification 

throughout the document. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on evaluating drug 

effects on the ability to operate a motor 

vehicle. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: November 3, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24367 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–0920] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Health and Diet 

Survey, as Used by the Food and Drug 

Administration 

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. 


sradovich on DSK3GMQ082PROD with NOTICES
52054 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

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 0910–0545. 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. 

Health and Diet Survey as Used by the 

Food and Drug Administration OMB 

Control Number 0910–0545—Extension 

We are seeking to renew OMB 

approval of the Health and Diet Survey, 

which is a voluntary consumer survey 

intended to gauge and to track consumer 

attitudes, awareness, knowledge, and 

behavior regarding various topics 

related to health, nutrition, physical 

activity, and product labeling. OMB 

approved this collection as a generic 

collection on December 5, 2014. The 

authority for FDA to collect the 

information derives from FDA’s 

Commissioner of Food and Drugs 

authority provided in section 1003(d)(2) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 393(d)(2)). 

We will use the Health and Diet 

Survey findings to test and refine our 

ideas, but will generally conduct further 

research before making important 

decisions such as adopting new policies 

and allocating or redirecting significant 

resources to support these policies. 

This survey has been repeated 

approximately every 3 to 5 years over 

the course of the past 3 decades for the 

purpose of tracking changes and trends 

in public opinions and consumer 

behavior, with some new questions 

added or omitted or partially modified 

in each iteration in response to 

emerging and current events or issues. 

In the next 3 years, we plan to field this 

survey two to three times. We will use 

the information from the Health and 

Diet Survey to evaluate and develop 

strategies and programs to encourage 

and help consumers adopt healthy diets 

and lifestyles. The information will also 

help FDA evaluate and track consumer 

awareness and behavior as outcome 

measures of their achievement in 

improving public health. 

Description of Respondents: The 

respondents are adults, age 18 and 

older, drawn from the 50 States and the 

District of Columbia. Participation will 

be voluntary. 

In the Federal Register of July 18, 

2017 (82 FR 32832), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received no comments. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Cognitive interview screener ........................................... 100 1 100 .08 ......................

(5 minutes) .........

8 

Cognitive interview .......................................................... 18 1 18 1 ......................... 18 

Pretest screener .............................................................. 2,000 1 2,000 .033 (2 minutes) 66 

Pretest ............................................................................. 200 1 200 .25 (15 minutes) 50 

Survey screener .............................................................. 40,000 1 40,000 .033 (2 minutes) 1,320 

Survey ............................................................................. 4,000 1 4,000 .25 (15 minutes) 1,000 

Total ......................................................................... ........................ ........................ ........................ ............................ 2,462 

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

We base our estimate of the number 

of respondents and the average burden 

per response on our experience with 

previous Health and Diet Surveys and 

we estimate that the burden for this 

information collection has increased by 

580 hours (from 1,882 to 2,462 hours) 

since the last OMB approval. The 

increase is due to an expected increase 

in the number of participants 

completing the survey screener (from 

30,000 to 40,000 participants) and 

number of participants taking the survey 

(from 3,000 to 4,000). We will use a 

cognitive interview screener with 100 

individuals to recruit prospective 

interview participants. We estimate that 

it will take a screener respondent 

approximately 5 minutes (0.08 hours) to 

complete the cognitive interview 

screener, for a total of 8 hours. We will 

conduct cognitive interviews with 18 

participants. We estimate that it will 

take a participant approximately 1 hour 

to complete the interview, for a total of 

18 hours. Prior to the administration of 

the Health and Diet Survey, the Agency 

plans to conduct a pretest to identify 

and resolve potential survey 

administration problems. We will use a 

pretest screener with 2,000 individuals; 

we estimate that it will take a 

respondent approximately 2 minutes 

(0.033 hours) to complete the pretest 

screener, for a total of 66 hours. The 

pretest will be conducted with 200 

participants; we estimate that it will 

take a participant 15 minutes (0.25 

hours) to complete the pretest, for a total 

of 50 hours. We will use a survey 

screener to select an eligible adult 

respondent in each household reached 

by landline telephone numbers to 

participate in the survey. A total of 

40,000 individuals in the 50 states and 

the District of Columbia will be 

screened by telephone. We estimate that 

it will take a respondent 2 minutes 

(0.033 hours) to complete the screening, 

for a total of 1,320 hours. We estimate 

that 4,000 eligible adults will participate 

in the survey, each taking 15 minutes 

(0.25 hours), for a total of 1,000 hours. 

Thus, the total estimated burden is 

2,462 hours. 

We are requesting this burden for 

unplanned surveys so as not to restrict 

our ability to gather information on 

consumer attitudes, awareness, 

knowledge, and behavior regarding 

various topics related to health, 

nutrition, physical activity, and product 

labeling. This ability will help the 


sradovich on DSK3GMQ082PROD with NOTICES
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