44800 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–20510 Filed 9–25–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Public Comment Request; 

Redesign of Existing Data Collection; 

National Survey of Older Americans 

Act Participants 

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 a proposed 

revision to an existing data collection 

related to the National Survey of Older 

Americans Act Participants 

(NSOAAP)(ICR Rev). 

DATES: Submit written or electronic 

comments on the collection of 

information by November 27, 2017. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: heather.menne@

acl.hhs.gov. 

Submit written comments on the 

collection of information to: U.S. 

Department of Health and Human 

Services, Administration for 

Community Living, Washington, DC 

20201, Attention: Heather Menne. 

FOR FURTHER INFORMATION CONTACT: 

Heather Menne by telephone: (202) 795– 

7733 or by email: heather.menne@

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. 

To comply with the above 

requirement, ACL is publishing a notice 

of the proposed revision of a currently 

approved 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. 

Purpose 

The purpose of this data collection is 

to fulfill requirements of the Older 

Americans Act and the Government 

Performance and Results Modernization 

Act of 2010 (GPRAMA) and related 

program performance activities. Section 

202(a)(16) of the OAA requires the 

collection of statistical data regarding 

the programs and activities carried out 

with funds provided under the OAA 

and Section 207(a) directs the Assistant 

Secretary for Aging to prepare and 

submit a report to the President and 

Congress based on those data. Section 

202(f) directs the Assistant Secretary to 

develop a set of performance measures 

for planning, managing, and evaluating 

activities performed and services 

provided under the OAA. Requirements 

pertaining to the measurement and 

evaluation of the impact of all programs 

authorized by the OAA are described in 

section 206(a). The National Survey of 

Older Americans Act Participants 

(NSOAAP) is one source of data used to 

develop and report performance 

outcome measures and measure 

program effectiveness in achieving the 

stated goals of the OAA. 

The National Survey of Older 

Americans Act Participants (NSOAAP) 

information collection will include 

consumer assessment surveys for the 

Congregate and Home-delivered meal 

nutrition programs; Case Management, 

Homemaker, and Transportation 

Services; and the National Family 

Caregiver Support Program. This survey 

builds on earlier national pilot studies 

and surveys, as well as performance 

measurement tools developed by ACL 

grantees in the Performance Outcomes 

Measures Project (POMP). This 

information will be used by ACL to 

track performance outcome measures; 

support budget requests; comply with 

the GPRA Modernization Act of 2010 

(GPRAMA) reporting requirements; 

provide national benchmark 

information; and inform program 

development and management 

initiatives. 

Revisions 

With the exception of changes to 

selected questions (e.g., addition of 

questions about oral health in 2014), the 

NSOAAP has been collected in its 

current form since 2008. This proposed 

collection is a revision that will replace 

the currently approved version (OMB 

Control Number: 0985–0023) by 

transitioning from a cross-sectional 

survey to a longitudinal survey. The 

current National Survey of Older 

Americans Act Participants (NSOAAP), 

an exclusively cross-sectional survey, 

can transition to a longitudinal 

information collection component by 

establishing a baseline cohort and 

conducting follow-up interviews with 

that cohort at specified time intervals. A 

baseline cohort can be selected in the 

same manner as in prior cycles of the 

cross-sectional NSOAAP. Area Agencies 

on Aging (AAAs) would be selected 

with a probability proportional to their 

size, with some large AAAs sampled 

with certainty. Random samples of 

clients within each selected AAA will 

be sampled from the agencies’ client 

lists. However, in a change from current 

procedures, the target sample size 

would be increased from current 

standards (n=6000) to account for 

attrition of individuals over time. For 

the duration of the longitudinal cohort 

analysis, the same sample of AAAs and 

clients should be maintained to preserve 

the longitudinal nature of the study. 

Three strategies are key for transforming 

the current survey into a longitudinal 

study, while preserving the ability to 

produce nationally representative crosssectional estimates of client 

characteristics at each wave. The three 

strategies include: (1) A higher initial 

sample size (n=6600), (2) an intensive 

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44801 

operational campaign to keep track of 

respondents over time, and (3) limiting 

the number of waves for each cohort 

study (e.g., three waves are proposed). 

The factors that influenced the 

proposed revision of the NSOAAP, 

include: 

(1) The need to minimize reporting 

burden on the AAAs by only having 

AAAs provide client lists for the initial 

data collection (as there would be no 

need to re-contact the AAAs until such 

time as a new longitudinal cohort would 

be established); 

(2) the opportunity to incorporate 

selected new questions and topics of 

interest based on public comment and 

the input from an expert workgroup 

comprised of gerontologists, survey 

methodologists, and OAA program 

experts; 

(3) the ability to provide more precise 

estimates of changes over time in 

measured quantities than repeated 

cross-sectional studies with the same 

sample size; 

(4) the ability to track certain types of 

attrition as outcomes (e.g., client 

transitions from independent living to 

group quarters; a client dies, a client no 

longer uses a service because of moving 

in with a family member); 

(5) the ability to examine changes in 

the natural history of physical 

functioning and health and how these 

outcomes relate to patterns of service 

utilization over the three annual data 

collections (e.g., to what extent do 

clients increase or decrease the use of 

services over time and what indicators 

are associated with the change in 

services?); and 

(6) the opportunity to add a rotating 

topical module in waves 2 and 3 to 

collect information on emerging issues 

(e.g., nutrition; health care access; or 

client experiences with discrimination 

based on age, sexual orientation, race, or 

other characteristics) and provide a 

broader picture of the types of 

individuals receiving OAA services. 

Burden Estimate 

The proposed NSOAAP revision 

reduces the estimated average hour 

burden per respondent by 11% 

compared to the current NSOAAP due 

to the proposed change of a longitudinal 

data collection in which Area Agencies 

on Aging need only provide client lists 

in the first of three years of data 

collection (compared to annually in the 

current cross-sectional data collection). 

Limited expansions in data elements are 

found in the Family Caregiver Survey. 

The proposal includes the addition of 

new questions about caregiving and the 

well-being of the caregiver. Across the 

OAA services, greater detail regarding 

falls, life changes, and social integration 

are proposed; for clients of Case 

Management Services, Congregate 

Nutrition, Home-delivered Nutrition, 

Homemaker Services, and 

Transportation Services, greater detail 

about food security is proposed. The 

ACL also seeks the opportunity to: (1) 

Introduce unique topical modules in 

waves 2 and 3 to collect information on 

emerging issues such as nutrition, 

health care access, or client experiences 

with discrimination based on age, 

sexual orientation, race, or other 

characteristics, and (2) conduct brief 

informant follow-up interviews in 

waves 2 and 3 when baseline 

respondents are unreachable. 

Taken as a whole, the proposed 

reductions exceed the proposed 

increases in data burden. The proposed 

information collection instruments may 

be found on the ACL Web site under 

Proposed Revisions for National Survey 

of Older Americans Act Participants 

(NSOAAP), available at: https://

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

The estimated average hour burden 

per respondent for the Redesigned 

NSOAAP will change from the 0.80 

hour estimate in 2017 to 0.71 hours, a 

decrease due to the proposed change of 

a longitudinal data collection in which 

Area Agencies on Aging need only 

provide client lists in the first of three 

years of data collection (compared to 

annually in the current cross-sectional 

data collection). ACL estimates the 

burden of this revised collection of 

information as follows: 

TABLE—ESTIMATED ANNUALIZED BURDEN HOURS

Respondent/data collection activity Number of 

respondents 

Responses per 

respondent 

Average hours per 

response 

Annual burden 

hours 

Baseline 

Area Agency on Aging: Respondent selection process ..................... 250 1 ..................... 4.0 .............................. 1,000 

Service Recipients (i.e., Case Management; Congregate Nutrition; 

Home-delivered Nutrition; Homemaker; Transportation).

4,400 1 ..................... .6667 .......................... 2,933 

National Family Caregiver Support Program Clients ......................... 2,200 1 ..................... .6667 .......................... 1,467 

Year 2 

Area Agency on Aging: Respondent selection process ..................... 0 0 ..................... 0 ................................. 0 

Service Recipients (i.e., Case Management; Congregate Nutrition; 

Home-delivered Nutrition; Homemaker; Transportation).

4,200 1 ..................... .6667 .......................... 2,800 

National Family Caregiver Support Program Clients ......................... 2,100 1 ..................... .6667 .......................... 1,400 

Year 3 

Area Agency on Aging: Respondent selection process ..................... 0 0 ..................... 0 ................................. 0 

Service Recipients (i.e., Case Management; Congregate Nutrition; 

Home-delivered Nutrition; Homemaker; Transportation).

4,000 1 ..................... .6667 .......................... 2,667 

National Family Caregiver Support Program Clients ......................... 2,000 1 ..................... .6667 .......................... 1,333 

Total ............................................................................................. 19,150 Varies ............. .710 (weighted mean) 13,600 

44802 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

Dated: September 19, 2017. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2017–20460 Filed 9–25–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0429] 

Classification of Products as Drugs 

and Devices and Additional Product 

Classification Issues; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry and FDA staff 

entitled ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues.’’ This guidance 

provides the Agency’s current thinking 

on approaches for classifying products 

as drugs and devices, and on certain 

additional product classification issues. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 26, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2011–D–0429 for ‘‘Classification of 

Products as Drugs and Devices & 

Additional Product Classification 

Issues.’’ 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 office 

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 the guidance document 

entitled ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues’’ to the Office of 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Associate Director for 

Policy, Office of Combination Products, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

5129, Silver Spring, MD 20993–0002, 

301–796–8930. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues.’’ This guidance 

finalizes two related draft guidance 

documents issued in June 2011, entitled 

‘‘Classification of Products as Drugs and 

Devices & Additional Product 

Classification Issues’’ and 

‘‘Interpretation of the Term ’Chemical 

Action’ in the Definition of Device 

under Section 201(h) of the Federal 

Food, Drug, and Cosmetic Act.’’ 

This guidance is intended to provide 

the Agency’s current thinking on 

approaches for classifying products as 

drugs and devices, and on certain 

additional product classification issues. 

FDA determines whether to classify a 

product as a drug or device based on the 

statutory definitions for these terms set 

forth in section 201(g) and (h) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 321(g) and 

(h)), respectively, as applied to the 

scientific data concerning the products