46248 Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 

collection workgroup composed of State 

AT program staff that met with ACL on 

several occasions to suggest revisions to 

the current instrument. The workgroup 

identified minor changes in several 

sections of the instrument, including the 

reporting of state-level and state 

leadership activities. For example, AT 

Device Reassignment and Open-Ended 

Loan have been combined into a single 

line in ‘‘A. Recipient Table.’’ This 

update aligns the AT APR with the State 

Plan for AT structure and will 

streamline data reporting by grantees. A 

separate module has been created for all 

the General Information for State AT 

programs that is consistent between the 

AT APR and the State Plan for AT. Data 

will be entered once and from that point 

forward only updates will be needed, 

which will streamline the data entry 

process for grantees. The Public 

Awareness table with numeric data has 

been replaced with two narrative text 

boxes. Numeric data reported in this 

section has been historically estimated 

with little consistency in how data is 

reported between grantees. With a shift 

to more electronic information sharing, 

quantified public awareness data is 

difficult to report for all grantees and 

aggregate data is not useful. This change 

will allow for qualitative data that is 

more helpful in understanding the 

activities conducted. The workgroup 

solicited feedback from all of the 

grantees through face-to-face meetings 

and webinar presentations. The number 

of hours is multiplied by 56 AT State 

Grants programs, resulting in a total 

estimated hour burden of 22,624 hours. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden 

hours 

State Grants for AT Annual Progress Report (AT APR) ................................. 56 1 80.0 4,480 

Performance Measure Surveys ....................................................................... 56 1 54.0 3,024 

Customer Satisfaction Surveys ....................................................................... 56 1 54.0 3,024 

Data Entry for the Instruments ........................................................................ 56 1 208.0 11,648 

Record Keeping Burden .................................................................................. 56 1 8.0 448 

Total .......................................................................................................... 56 1 404.0 22,624 

Estimated Total Annual Burden 

Hours: 22,624. 

Dated: September 27, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–21259 Filed 10–3–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5624] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Content and 

Format of Labeling for Human 

Prescription Drugs and Biological 

Products; Requirements for Pregnancy 

and Lactation Labeling 

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 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the content and 

format requirements for pregnancy and 

lactation labeling for human 

prescription drugs and biological 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 4, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 4, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 4, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

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– 

2017–N–5624 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Content 

and Format of Labeling for Human 

Prescription Drugs and Biological 

Products; Requirements for Pregnancy 

and Lactation Labeling.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 46249 

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. 

FOR FURTHER INFORMATION, CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Content and Format of Labeling for 

Human Prescription Drugs and 

Biological Products; Requirements for 

Pregnancy and Lactation Labeling 

OMB Control Number 0910–0624— 

Extension 

This information collection supports 

Agency regulations regarding the 

content and format requirements for 

pregnancy and lactation labeling. In the 

Federal Register of December 4, 2014 

(79 FR 72064), FDA published a final 

rule entitled ‘‘Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products; Requirements 

for Pregnancy and Lactation Labeling.’’ 

The final rule amended FDA regulations 

concerning the content and format of 

the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ 

and ‘‘Nursing mothers’’ subsections of 

the ‘‘Use in Specific Populations’’ 

section of the labeling for human 

prescription drugs. The regulations now 

require, among other things, a summary 

of the risks of using a drug during 

pregnancy and lactation and a 

discussion of the data supporting that 

summary. The labeling must also 

include relevant information to help 

health care providers make prescribing 

decisions and counsel women about the 

use of drugs during pregnancy and 

lactation. The final rule eliminated the 

pregnancy categories A, B, C, D, and X. 

In addition, FDA eliminated the ‘‘Labor 

and delivery’’ subsection because the 

‘‘Pregnancy’’ subsection includes 

information on labor and delivery. The 

final rule also required that labeling 

include relevant information about 

pregnancy testing, contraception, and 

infertility for health care providers 

prescribing for females and males of 

reproductive potential. In addition, the 

final rule provided for a 10-year 

implementation schedule for 

compliance with the relevant 

regulations. As the implementation 

schedule is realized, FDA plans to 

discontinue this separate information 

collection and incorporate the 

provisions into existing collections, as 

appropriate. 

The content and format requirements 

apply to: 

• Applications submitted on or after 

June 30, 2015 (§§ 314.50 (21 CFR 

314.50), 314.70(b), 601.2 (21 CFR 601.2), 

and 601.12(f)(1)); 

• amendments to applications 

pending on June 30, 2015 (§§ 314.60 (21 

CFR 314.60), 601.2, and 601.12(f)(1)); 

• supplements to applications 

approved from June 30, 2001 to June 30, 

2015 (§§ 314.70(b) and 601.12(f)(1)); and 

• annual reports for applications 

approved before June 30, 2001, that 

contain a pregnancy category, to report 

removal of the pregnancy category letter 

in their labeling (§§ 314.70(d) and 

601.12(f)(3)). 

Under 21 CFR 201.57(c)(9)(i) and (ii)), 

holders of approved applications must 

provide new labeling content in a new 

format—that is, to rewrite the pregnancy 

and lactation portions of each drug’s 

labeling. Section 201.57(c)(9)(iii) 

requires that labeling must include the 

new subsection 8.3, ‘‘Females and males 

of reproductive potential.’’ Application 

holders are required to submit prior 

approval supplements to their approved 

applications before distribution of the 

new labeling, as required in § 314.70(b) 

(21 CFR 314.70(b)) or § 601.12(f)(1) (21 

CFR 601.12(f)(1)). 

Under 21 CFR 201.80(f)(6)(i), holders 

of approved applications are required to 

remove the pregnancy category 

designation (e.g., ‘‘Pregnancy Category 

C’’) from the ‘‘Pregnancy’’ subsection of 

the ‘‘Precautions’’ section of the 

labeling. These application holders 

must report the labeling change in their 

annual reports, as required in 

§ 314.70(d) or § 601.12(f)(3). 

As indicated in Tables 1 and 2 of this 

document, we estimate that the burden 

associated with the information 

collection to be 1,598,000 hours. 


sradovich on DSK3GMQ082PROD with NOTICES
46250 Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of submission 

(21 CFR section) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Supplements to applications approved 6/30/01 

to 6/30/15 (§§ 314.70(b), 601.12(f)(1)).

390 26 10,140 (Submitted 3rd, 

4th, and 5th years 

after 6/30/15).

120 1,216,800 

Annual report submission of revised labeling 

for applications that contain a pregnancy category, approved before 6/30/01 

(§§ 314.70(d), 601.12(f)(3)).

320 ∼17 5,500 (Submitted 3rd 

year after 6/30/15).

40 220,000 

Total ............................................................ ........................ .......................... ........................................ ........................ 1,436,800 

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

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Type of submission 

(21 CFR section) 

Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

New Drug Applications (NDAs)/Abbreviated 

New Drug Applications (ANDAs)/Biologics License Applications (BLAs)/efficacy supplements submitted on or after 6/30/15, including 

amendments to applications pending as of 6/ 

30/15 (§§ 314.50) 314.60, 314.70(b), 601.2, 

601.12(f)(1)).

390 ∼10 4,000 (Submitted during 

10-year period after 

6/30/15).

40 160,000 

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

FDA estimates that approximately 

4,000 applications containing the 

subject labeling will be submitted by 

approximately 390 applicants and 

repackagers and relabelers to FDA over 

the 10-year period beginning June 30, 

2015. This figure (4,000 applications) 

includes labeling for approximately 800 

applications submitted under section 

505(b) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

505(b)) or section 351 of the Public 

Health Service Act (42 U.S.C. 262), 

1,200 applications submitted under 

section 505(j) of the FD&C Act, and 

2,000 revised drug product labeling 

from repackagers and relabelers for 

approximately 2,000 applications. This 

estimate also includes labeling 

amendments submitted to FDA for 

applications pending as of the effective 

date of the final rule. FDA estimates that 

it will take applicants approximately 40 

hours to prepare and submit the subject 

labeling. This estimate applies only to 

the requirements of the final rule and 

does not indicate the total hours 

required to prepare and submit 

complete labeling for these applications. 

The information collection burden to 

prepare and submit labeling in 

accordance with §§ 201.56 (21 CFR 

201.56), 201.57, and 201.80 is approved 

by OMB under control numbers 0910– 

0572 and 0910–0001. 

In addition, during the 3rd, 4th, and 

5th years after the effective date of the 

final rule, the Agency estimates that it 

will receive approximately 10,150 

supplements to applications that were 

either approved from June 30, 2001, to 

the effective date or were pending as of 

the effective date. This estimate 

includes supplements for approximately 

1,080 NDAs, BLAs, and efficacy 

supplements; 1,320 ANDA 

supplements; and 7,750 drug product 

labeling supplements from repackagers 

and relabelers. FDA estimates that 

approximately 390 application holders, 

repackagers, and relabelers will submit 

these supplements, and that it will take 

approximately 120 hours to prepare and 

submit each supplement. 

FDA also estimates that application 

holders will submit approximately 

5,500 annual reports to FDA during the 

third year after the effective date for 

applications that contain a pregnancy 

category, approved before June 30, 2001. 

This estimate includes approximately 

1,340 NDAs and BLAs, and 

approximately 4,160 ANDAs containing 

labeling changes as a result of the final 

rule. FDA estimates that approximately 

320 application holders will submit 

these annual reports, and that it will 

take approximately 40 hours for each 

submission. 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21292 Filed 10–3–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Patient Engagement Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

amendments to the notice of meeting of 

the Patient Engagement Advisory 

Committee. This meeting was 

announced in the Federal Register of 

July 26, 2017. The amendments are 

being made to reflect time changes in 

the DATES and Procedure sections and to 

add Webcast Information to the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Center for Devices and 

Radiological Health, Food and Drug 


sradovich on DSK3GMQ082PROD with NOTICES