Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 46247 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

State Councils on Developmental Disabilities Annual Program Performance 

Report (PPR) ................................................................................................ 56 1 172 9,632 

Total .......................................................................................................... 56 1 172 9,632 

Dated: September 26, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–21258 Filed 10–3–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request; Revision of a 

Currently Approved Information 

Collection (OMB Approval Number 

0985–0042); State Grant for Assistive 

Technology Program Annual Progress 

Report (AT APR) 

AGENCY: Administration for Community 

Living, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

that the proposed collection of 

information listed above has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance as required under the 

Paperwork Reduction Act of 1995 (the 

PRA). This 30-day notice requests 

comments on the information collection 

requirements related to a proposed 

Revision of a Currently Approved 

Information Collection (ICR-Rev). The 

revision would allow ACL to continue 

to collect information necessary to 

determine grantee compliance with 

Section 4 of the Assistive Technology 

Act of 1998, as Amended (AT Act). 

DATES: Submit written comments on the 

collection of information by November 

3, 2017. 

ADDRESSES: Submit written comments 

on the collection of information: by fax 

at (202) 395–5806 or by email to OIRA_

submission@omb.eop.gov, Attn: OMB 

Desk Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Robert Groenendaal at (202) 795–7356 

or robert.groenendaal@acl.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 44 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 or 

update of an existing collection of 

information, before submitting the 

collection to OMB for approval. The 

proposed data collection represents a 

revision of a currently approved 

information collection. In order to 

comply with the above requirement, 

ACL is requesting approval of an update 

of a previously approved collection, the 

State Grants for Assistive Technology 

Program Annual Progress Report (AT 

APR), formerly the 572 Report (0985– 

0042). 

The AT APR is submitted annually by 

all State Grants for AT programs 

receiving formula funds under Section 4 

of the Assistive Technology Act of 1998, 

as Amended (AT Act). The AT APR is 

used by ACL to assess grantees’ 

compliance with Section 4 of the AT 

Act, with section 1329 of the Code of 

Federal Regulations, and with 

applicable provisions of the HHS 

regulations at 45 CFR part 75. The AT 

APR enables ACL to analyze qualitative 

and quantitative data to track 

performance outcomes and efficiency 

measures of the State Grants for AT 

programs; support budget requests; 

comply with the GPRA Modernization 

Act of 2010 (GPRAMA) reporting 

requirements; provide national 

benchmark information; and inform 

program development and management 

activities. This information collection 

has 3 pieces: (a) Web-based system that 

collects data from states; (b) 

performance measure survey on the 

access and acquisition of AT devices 

and services that states collect from 

individuals; and, (c) customer 

satisfaction survey that states collect 

from individuals on their experiences 

accessing and acquiring AT through the 

State AT program. The burden table 

below identifies the data collection 

activities for the three surveys above as 

well as the estimates for record keeping 

and entry of aggregate data. In addition 

to submitting a State Plan every three 

years, states and outlying areas are 

required to submit annual progress 

reports on their activities. The data 

required for these progress reports is 

specified in Section 4(f) of the AT Act. 

The State Grants for AT program 

conduct the following state-level and 

state leadership activities: State 

financing, device demonstration, device 

loans, device reutilization, training and 

technical assistance, public awareness, 

and information and referral. 

Comments in Response to the 60-Day 

Federal Register Notice 

A 60-Day notice was published in the 

Federal Register in Vol. 82, No. 135, pg. 

32710, on July 17th, 2017. ACL received 

one comment from the Association of 

Assistive Technology Act Programs 

(ATAP), which represents 54 State 

Grant for AT programs. The comment 

noted that the proposed changes to the 

currently approved information 

collection were developed with 

extensive input of those it directly 

impacts, the State AT Program grantees. 

The revision process began over two 

years ago and grantees had multiple 

opportunities to discuss and make 

recommendations on the proposed 

changes, which were reviewed during 

numerous meetings with ATAP 

membership at national conferences and 

during online events. There is uniform 

support within the ATAP membership 

for the revisions. 

Annual Burden Estimates 

The proposed State Grants for 

Assistive Technology Program Annual 

Progress Report (AT APR) may be found 

on the ACL Web site at: https://

www.acl.gov/about-acl/public-input. 

The total estimated hour burden per 

respondent for the proposed AT APR 

will decrease from the 406 hours per 

respondent estimated in FY 2014 to 404 

hours estimated for FY 2017, an 

estimated reduction of two hours per 

respondent or 112 in total. These are in 

addition to reductions made during the 

last information collection process. The 

reduction in burden is a result of a data 


sradovich on DSK3GMQ082PROD with NOTICES
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