46064 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

Dated: September 28, 2017. 

William N. Parham, III 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–21248 Filed 10–2–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Public Comment Request; 

Proposed Extension With Changes of 

a Currently Approved Collection; 

Evidence-Based Falls Prevention 

Program 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

an opportunity for the public to 

comment on the proposed collection of 

certain information by the agency. 

Under the Paperwork Reduction Act of 

1995 (the PRA), Federal agencies are 

required to publish a 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 information 

collection requirements relating to 

ACL’s Evidence-Based Falls Prevention 

Program. This notice solicits comments 

on a proposed extension with minor 

changes of a currently approved 

collection. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 4, 2017. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to shannon.skowronski@

acl.hhs.gov. Submit written comments 

on the collection of information to: 

Shannon Skowronski, U.S. Department 

of Health and Human Services: 

Administration for Community Living, 

Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Skowronski at 

shannon.skowronski@acl.hhs.gov or 

202–795–7438. 

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. To 

comply with this requirement, ACL is 

publishing notice of the proposed 

collection of information set forth in 

this document. 

With respect to the following 

collection of information, ACL invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of ACL’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of ACL’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. 

The Evidence-Based Falls Prevention 

Programs is a cooperative agreement 

financed through the Prevention and 

Public Health Fund (PPHF), most 

recently with FY 2017 PPHF funds. The 

statutory authority for cooperative 

agreements under the current program 

announcement is contained in the 

Public Health Service Act, 42 U.S.C. 

300u–2 (Community Programs) and 

300u–3 (Information Programs); and 

Consolidated and Further Continuing 

Appropriations Act, 2015, Pub. L. 113– 

235, Div. G., Title II, § 219(a); and the 

Patient Protection and Affordable Care 

Act, 42 U.S.C. 300u–11 (Prevention and 

Public Health Fund). 

The Evidence-Based Falls Prevention 

Programs support a national resource 

center and award competitive grants to 

implement evidence-based community 

programs that have been proven to 

reduce the incidence of falls for older 

adults and adults with disabilities 

(including Tribal elders). The programs 

also identify sustainable funding 

mechanisms for these programs via the 

resource center, promote the importance 

of falls prevention strategies, and 

provide public education about the risks 

of falls and ways to prevent them. 

OMB approval of the existing set of 

Falls Prevention data collection tools 

(OMB Control Number, 0985–0039) 

expires on 01/31/2018. This data 

collection continues to be necessary for 

monitoring program operations and 

outcomes. ACL/AoA proposes to use the 

following tools: (1) Semi-annual 

performance reports to monitor grantee 

progress; (2) a Host Organization Data 

form to record location of agencies that 

sponsor programs that will allow 

mapping of the delivery infrastructure; 

and (3) a set of tools used to collect 

information at each program completed 

by the program leaders (Program 

Information Cover Sheet and 

Attendance Log), a Participant 

Information Form completed by each 

participant, and a Post Program Survey 

to be completed by a random sample of 

participants. ACL/AoA intends to 

continue using an online data entry 

system for the program and participant 

survey data. In addition to nonsubstantive formatting edits, minor 

changes are being proposed to 2 of the 

5 currently approved tools, as indicated 

below. All changes proposed are based 

on feedback from a focus group that 

included a sub-set of current grantees 

and consultation with subject-matter 

experts. 

• On the Participant Information 

Form: 

1. Additional chronic conditions have 

been added to the list of options 

2. Question #11 (assessing the 

frequency and impact of falls) has been 

enhanced to include the location of the 

fall(s) and further assess impact 

3. Two questions have been added 

(#15 and #16) to examine modifications 

made to home and activity level 

• On the Post-Program Survey: 

1. Question #2 (assessing the 

frequency and impact of falls) has been 

enhanced to include the location of the 

fall(s) and further assess impact 

2. Questions #6 and #7 have been 

modified slightly—removing references 

to home modifications and activity 

level. Home modifications and activity 

level are now addressed in questions #8 

and #9 instead. 

Estimated Annualized Burden Hours 

The proposed Falls Prevention Data 

Collection Tools can be found at ACL’s 

Web site at: https://www.acl.gov/aboutacl/public-input. 

The total estimated burden is 4,345 

hours per year. ACL/AoA estimates the 

burden of this collection of information 

as 288 hours for project staff, 1,435 

hours for local agency staff, and 2,622 

hours for individuals. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46065 

Type of 

respondent Form name Estimated number of respondents 

Number of responses 

per respondent 

Average 

time per 

response 

(in hours) 

Total 

burden 

hours 

(annual) 

Project staff ............................... Semi-annual Performance Report ..................... 18 ................................ Twice a year ............................. 8 288 

Local agency leaders ................ Program Information Cover Sheet/Participant 

Information Form/Attendance Log/Post Program Survey.

700 leaders ................. Twice a year (one set per program)..50 700 

Local data entry staff ................ 46 data entry staff ...... Once per program x 1400 programs..50 700 

Local organization staff and 

local database entry staff.

Host Organization Data Form ........................... 700 staff ...................... 1 ............................................... .05 35 

Program participants ................. Participant Information Form ............................. 16,390 ......................... 1 ............................................... .10 1,639 

Program participants ................. Post Program Survey ........................................ 983 .............................. 1 ............................................... .10 983 

Total Burden Hours ........... ............................................................................ ..................................... ................................................... ................ 4,345 

Dated: September 20, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–21179 Filed 10–2–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5437] 

Topical Dermatological Generic Drug 

Products: Overcoming Barriers to 

Development and Improving Patient 

Access; Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Topical 

Dermatological Generic Drug Products: 

Overcoming Barriers to Development 

and Improving Patient Access.’’ The 

purpose of the public workshop is to 

provide an overview of current 

regulatory science initiatives related to 

generic topical dermatological drug 

products, solicit public input on 

scientific barriers that may limit patient 

access to such drug products, and 

discuss approaches to overcome/address 

any such barriers. FDA is seeking public 

input from a variety of stakeholders, 

including industry, academia, patient 

advocates, and professional 

associations. 

DATES: The public workshop will be 

held on October 20, 2017, from 8:30 

a.m. to 4:30 p.m., Eastern Standard 

Time. Submit either electronic or 

written comments on this public 

workshop by November 20, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/Workingat

FDA/BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

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 November 20, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 20, 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–5437 for ‘‘Topical 

Dermatological Generic Drug Products: 

Overcoming Barriers to Development 

and Improving Patient Access.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES