82_FR_44985 82 FR 44800 - Agency Information Collection Activities; Public Comment Request; Redesign of Existing Data Collection; National Survey of Older Americans Act Participants

82 FR 44800 - Agency Information Collection Activities; Public Comment Request; Redesign of Existing Data Collection; National Survey of Older Americans Act Participants

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living

Federal Register Volume 82, Issue 185 (September 26, 2017)

Page Range44800-44802
FR Document2017-20460

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).

Federal Register, Volume 82 Issue 185 (Tuesday, September 26, 2017)
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44800-44802]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20460]


-----------------------------------------------------------------------

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: [email protected].
    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: [email protected].

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 cross-
sectional estimates of client characteristics at each wave. The three 
strategies include: (1) A higher initial sample size (n=6600), (2) an 
intensive

[[Page 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      Number of       Responses per                                    Annual burden
           activity              respondents        respondent       Average hours per  response       hours
----------------------------------------------------------------------------------------------------------------
                                                    Baseline
----------------------------------------------------------------------------------------------------------------
Area Agency on Aging:                     250  1..................  4.0.........................           1,000
 Respondent selection process.
Service Recipients (i.e.,               4,400  1..................  .6667.......................           2,933
 Case Management; Congregate
 Nutrition; Home-delivered
 Nutrition; Homemaker;
 Transportation).
National Family Caregiver               2,200  1..................  .6667.......................           1,467
 Support Program Clients.
----------------------------------------------------------------------------------------------------------------
                                                     Year 2
----------------------------------------------------------------------------------------------------------------
Area Agency on Aging:                       0  0..................  0...........................               0
 Respondent selection process.
Service Recipients (i.e.,               4,200  1..................  .6667.......................           2,800
 Case Management; Congregate
 Nutrition; Home-delivered
 Nutrition; Homemaker;
 Transportation).
National Family Caregiver               2,100  1..................  .6667.......................           1,400
 Support Program Clients.
----------------------------------------------------------------------------------------------------------------
                                                     Year 3
----------------------------------------------------------------------------------------------------------------
Area Agency on Aging:                       0  0..................  0...........................               0
 Respondent selection process.
Service Recipients (i.e.,               4,000  1..................  .6667.......................           2,667
 Case Management; Congregate
 Nutrition; Home-delivered
 Nutrition; Homemaker;
 Transportation).
National Family Caregiver               2,000  1..................  .6667.......................           1,333
 Support Program Clients.
                                              ------------------------------------------------------------------
    Total....................          19,150  Varies.............  .710 (weighted mean)........          13,600
----------------------------------------------------------------------------------------------------------------



[[Page 44802]]

    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



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

     Leroy A. Richardson,                                    1320.3(c) and includes agency requests                   The National Survey of Older
     Chief, Information Collection Review Office,            or requirements that members of the                   Americans Act Participants (NSOAAP)
     Office of Scientific Integrity, Office of the           public submit reports, keep records, or               information collection will include
     Associate Director for Science, Office of the           provide information to a third party.                 consumer assessment surveys for the
     Director, Centers for Disease Control and               Section 3506(c)(2)(A) of the PRA (44                  Congregate and Home-delivered meal
     Prevention.                                             U.S.C. 3506(c)(2)(A)) requires Federal                nutrition programs; Case Management,
     [FR Doc. 2017–20510 Filed 9–25–17; 8:45 am]             agencies to provide a 60-day notice in                Homemaker, and Transportation
     BILLING CODE 4163–18–P                                  the Federal Register concerning each                  Services; and the National Family
                                                             proposed collection of information,                   Caregiver Support Program. This survey
                                                             including each proposed extension or                  builds on earlier national pilot studies
     DEPARTMENT OF HEALTH AND                                update of an existing collection of                   and surveys, as well as performance
     HUMAN SERVICES                                          information, before submitting the                    measurement tools developed by ACL
                                                             collection to OMB for approval.                       grantees in the Performance Outcomes
     Administration for Community Living                                                                           Measures Project (POMP). This
                                                                To comply with the above
     Agency Information Collection                           requirement, ACL is publishing a notice               information will be used by ACL to
     Activities; Public Comment Request;                     of the proposed revision of a currently               track performance outcome measures;
     Redesign of Existing Data Collection;                   approved collection of information set                support budget requests; comply with
     National Survey of Older Americans                      forth in this document. With respect to               the GPRA Modernization Act of 2010
     Act Participants                                        the following collection of information,              (GPRAMA) reporting requirements;
                                                             ACL invites comments on: (1) Whether                  provide national benchmark
     AGENCY:  Administration for Community                   the proposed collection of information                information; and inform program
     Living, HHS.                                            is necessary for the proper performance               development and management
     ACTION: Notice.                                         of ACL’s functions, including whether                 initiatives.
     SUMMARY:   The Administration for                       the information will have practical                   Revisions
     Community Living (ACL) is announcing                    utility; (2) the accuracy of ACL’s                       With the exception of changes to
     an opportunity for the public to                        estimate of the burden of the proposed                selected questions (e.g., addition of
     comment on the proposed collection of                   collection of information, including the              questions about oral health in 2014), the
     certain information by the agency.                      validity of the methodology and                       NSOAAP has been collected in its
     Under the Paperwork Reduction Act of                    assumptions used; (3) ways to enhance                 current form since 2008. This proposed
     1995 (the PRA), Federal agencies are                    the quality, utility, and clarity of the              collection is a revision that will replace
     required to publish a notice in the                     information to be collected; and (4)                  the currently approved version (OMB
     Federal Register concerning each                        ways to minimize the burden of the                    Control Number: 0985–0023) by
     proposed collection of information,                     collection of information on                          transitioning from a cross-sectional
     including each proposed extension of an                 respondents, including through the use                survey to a longitudinal survey. The
     existing collection of information, and                 of automated collection techniques                    current National Survey of Older
     to allow 60 days for public comment in                  when appropriate, and other forms of                  Americans Act Participants (NSOAAP),
     response to the notice. This notice                     information technology.                               an exclusively cross-sectional survey,
     solicits comments on a proposed                         Purpose                                               can transition to a longitudinal
     revision to an existing data collection                                                                       information collection component by
     related to the National Survey of Older                   The purpose of this data collection is              establishing a baseline cohort and
     Americans Act Participants                              to fulfill requirements of the Older                  conducting follow-up interviews with
     (NSOAAP)(ICR Rev).                                      Americans Act and the Government                      that cohort at specified time intervals. A
                                                             Performance and Results Modernization                 baseline cohort can be selected in the
     DATES: Submit written or electronic
                                                             Act of 2010 (GPRAMA) and related                      same manner as in prior cycles of the
     comments on the collection of
                                                             program performance activities. Section               cross-sectional NSOAAP. Area Agencies
     information by November 27, 2017.
                                                             202(a)(16) of the OAA requires the                    on Aging (AAAs) would be selected
     ADDRESSES: Submit electronic
                                                             collection of statistical data regarding              with a probability proportional to their
     comments on the collection of                           the programs and activities carried out               size, with some large AAAs sampled
     information to: heather.menne@                          with funds provided under the OAA                     with certainty. Random samples of
     acl.hhs.gov.                                            and Section 207(a) directs the Assistant
        Submit written comments on the                                                                             clients within each selected AAA will
                                                             Secretary for Aging to prepare and                    be sampled from the agencies’ client
     collection of information to: U.S.
                                                             submit a report to the President and                  lists. However, in a change from current
     Department of Health and Human
                                                             Congress based on those data. Section                 procedures, the target sample size
     Services, Administration for
                                                             202(f) directs the Assistant Secretary to             would be increased from current
     Community Living, Washington, DC
                                                             develop a set of performance measures                 standards (n=6000) to account for
     20201, Attention: Heather Menne.
                                                             for planning, managing, and evaluating                attrition of individuals over time. For
     FOR FURTHER INFORMATION CONTACT:                        activities performed and services                     the duration of the longitudinal cohort
     Heather Menne by telephone: (202) 795–                  provided under the OAA. Requirements                  analysis, the same sample of AAAs and
     7733 or by email: heather.menne@                        pertaining to the measurement and                     clients should be maintained to preserve
     acl.hhs.gov.                                            evaluation of the impact of all programs              the longitudinal nature of the study.
     SUPPLEMENTARY INFORMATION: Under the                    authorized by the OAA are described in                Three strategies are key for transforming
     PRA (44 U.S.C. 3501–3520), Federal                      section 206(a). The National Survey of                the current survey into a longitudinal
     agencies must obtain approval from the                  Older Americans Act Participants                      study, while preserving the ability to
     Office of Management and Budget                         (NSOAAP) is one source of data used to                produce nationally representative cross-
     (OMB) for each collection of                            develop and report performance                        sectional estimates of client
     information they conduct or sponsor.                    outcome measures and measure                          characteristics at each wave. The three
     ‘‘Collection of information’’ is defined                program effectiveness in achieving the                strategies include: (1) A higher initial
     in 44 U.S.C. 3502(3) and 5 CFR                          stated goals of the OAA.                              sample size (n=6600), (2) an intensive


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

     operational campaign to keep track of                                     collections (e.g., to what extent do                                 Homemaker Services, and
     respondents over time, and (3) limiting                                   clients increase or decrease the use of                              Transportation Services, greater detail
     the number of waves for each cohort                                       services over time and what indicators                               about food security is proposed. The
     study (e.g., three waves are proposed).                                   are associated with the change in                                    ACL also seeks the opportunity to: (1)
        The factors that influenced the                                        services?); and                                                      Introduce unique topical modules in
     proposed revision of the NSOAAP,                                             (6) the opportunity to add a rotating                             waves 2 and 3 to collect information on
     include:                                                                  topical module in waves 2 and 3 to                                   emerging issues such as nutrition,
        (1) The need to minimize reporting                                     collect information on emerging issues                               health care access, or client experiences
     burden on the AAAs by only having                                         (e.g., nutrition; health care access; or                             with discrimination based on age,
     AAAs provide client lists for the initial                                 client experiences with discrimination                               sexual orientation, race, or other
     data collection (as there would be no                                                                                                          characteristics, and (2) conduct brief
                                                                               based on age, sexual orientation, race, or
     need to re-contact the AAAs until such                                                                                                         informant follow-up interviews in
                                                                               other characteristics) and provide a
     time as a new longitudinal cohort would                                                                                                        waves 2 and 3 when baseline
                                                                               broader picture of the types of
     be established);                                                                                                                               respondents are unreachable.
        (2) the opportunity to incorporate                                     individuals receiving OAA services.
                                                                                                                                                       Taken as a whole, the proposed
     selected new questions and topics of                                      Burden Estimate                                                      reductions exceed the proposed
     interest based on public comment and
                                                                                  The proposed NSOAAP revision                                      increases in data burden. The proposed
     the input from an expert workgroup
     comprised of gerontologists, survey                                       reduces the estimated average hour                                   information collection instruments may
     methodologists, and OAA program                                           burden per respondent by 11%                                         be found on the ACL Web site under
     experts;                                                                  compared to the current NSOAAP due                                   Proposed Revisions for National Survey
        (3) the ability to provide more precise                                to the proposed change of a longitudinal                             of Older Americans Act Participants
     estimates of changes over time in                                         data collection in which Area Agencies                               (NSOAAP), available at: https://
     measured quantities than repeated                                         on Aging need only provide client lists                              www.acl.gov/about-acl/public-input.
     cross-sectional studies with the same                                     in the first of three years of data                                     The estimated average hour burden
     sample size;                                                              collection (compared to annually in the                              per respondent for the Redesigned
        (4) the ability to track certain types of                              current cross-sectional data collection).                            NSOAAP will change from the 0.80
     attrition as outcomes (e.g., client                                       Limited expansions in data elements are                              hour estimate in 2017 to 0.71 hours, a
     transitions from independent living to                                    found in the Family Caregiver Survey.                                decrease due to the proposed change of
     group quarters; a client dies, a client no                                The proposal includes the addition of                                a longitudinal data collection in which
     longer uses a service because of moving                                   new questions about caregiving and the                               Area Agencies on Aging need only
     in with a family member);                                                 well-being of the caregiver. Across the                              provide client lists in the first of three
        (5) the ability to examine changes in                                  OAA services, greater detail regarding                               years of data collection (compared to
     the natural history of physical                                           falls, life changes, and social integration                          annually in the current cross-sectional
     functioning and health and how these                                      are proposed; for clients of Case                                    data collection). ACL estimates the
     outcomes relate to patterns of service                                    Management Services, Congregate                                      burden of this revised collection of
     utilization over the three annual data                                    Nutrition, Home-delivered Nutrition,                                 information as follows:

                                                                      TABLE—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                   Number of        Responses per                Average hours per                  Annual burden
                             Respondent/data collection activity                                                  respondents        respondent                      response                          hours

                                                                                                                Baseline

     Area Agency on Aging: Respondent selection process .....................                                                 250   1 .....................   4.0 ..............................            1,000
     Service Recipients (i.e., Case Management; Congregate Nutrition;                                                       4,400   1 .....................   .6667 ..........................              2,933
       Home-delivered Nutrition; Homemaker; Transportation).
     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;                                                       4,200   1 .....................   .6667 ..........................              2,800
       Home-delivered Nutrition; Homemaker; Transportation).
     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;                                                       4,000   1 .....................   .6667 ..........................              2,667
       Home-delivered Nutrition; Homemaker; Transportation).
     National Family Caregiver Support Program Clients .........................                                            2,000   1 .....................   .6667 ..........................              1,333

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




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

       Dated: September 19, 2017.                            do not wish to be made available to the               fdsys/pkg/FR-2015-09-18/pdf/2015-
     Lance Robertson,                                        public, submit the comment as a                       23389.pdf.
     Administrator and Assistant Secretary for               written/paper submission and in the                      Docket: For access to the docket to
     Aging.                                                  manner detailed (see ‘‘Written/Paper                  read background documents or the
     [FR Doc. 2017–20460 Filed 9–25–17; 8:45 am]             Submissions’’ and ‘‘Instructions’’).                  electronic and written/paper comments
     BILLING CODE 4154–01–P
                                                             Written/Paper Submissions                             received, go to https://
                                                                                                                   www.regulations.gov and insert the
                                                  Submit written/paper submissions as                              docket number, found in brackets in the
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     HUMAN SERVICES                               • Mail/Hand delivery/Courier (for                                ‘‘Search’’ box and follow the prompts
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                                               information you claim to be confidential                               FDA is announcing the availability of
     Electronic Submissions                    with a heading or cover note that states                            a guidance for industry and FDA staff
       Submit electronic comments in the       ‘‘THIS DOCUMENT CONTAINS                                            entitled ‘‘Classification of Products as
     following way:                            CONFIDENTIAL INFORMATION.’’ The                                     Drugs and Devices & Additional Product
       • Federal eRulemaking Portal: https:// Agency will review this copy, including                              Classification Issues.’’ This guidance
     www.regulations.gov. Follow the           the claimed confidential information, in                            finalizes two related draft guidance
     instructions for submitting comments.     its consideration of comments. The                                  documents issued in June 2011, entitled
     Comments submitted electronically,        second copy, which will have the                                    ‘‘Classification of Products as Drugs and
     including attachments, to https://        claimed confidential information                                    Devices & Additional Product
     www.regulations.gov will be posted to     redacted/blacked out, will be available                             Classification Issues’’ and
     the docket unchanged. Because your        for public viewing and posted on                                    ‘‘Interpretation of the Term ’Chemical
     comment will be made public, you are      https://www.regulations.gov. Submit                                 Action’ in the Definition of Device
     solely responsible for ensuring that your both copies to the Dockets Management                               under Section 201(h) of the Federal
     comment does not include any              Staff. If you do not wish your name and                             Food, Drug, and Cosmetic Act.’’
     confidential information that you or a    contact information to be made publicly                                This guidance is intended to provide
     third party may not wish to be posted,    available, you can provide this                                     the Agency’s current thinking on
     such as medical information, your or      information on the cover sheet and not                              approaches for classifying products as
     anyone else’s Social Security number, or in the body of your comments and you                                 drugs and devices, and on certain
     confidential business information, such must identify this information as                                     additional product classification issues.
     as a manufacturing process. Please note   ‘‘confidential.’’ Any information marked                            FDA determines whether to classify a
     that if you include your name, contact    as ‘‘confidential’’ will not be disclosed                           product as a drug or device based on the
     information, or other information that    except in accordance with 21 CFR 10.20                              statutory definitions for these terms set
     identifies you in the body of your        and other applicable disclosure law. For                            forth in section 201(g) and (h) of the
     comments, that information will be        more information about FDA’s posting                                Federal Food, Drug, and Cosmetic Act
     posted on https://www.regulations.gov.    of comments to public dockets, see 80                               (the FD&C Act) (21 U.S.C. 321(g) and
       • If you want to submit a comment       FR 56469, September 18, 2015, or access                             (h)), respectively, as applied to the
     with confidential information that you    the information at: https://www.gpo.gov/                            scientific data concerning the products


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Document Created: 2017-09-26 02:48:53
Document Modified: 2017-09-26 02:48:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit written or electronic comments on the collection of information by November 27, 2017.
ContactHeather Menne by telephone: (202) 795- 7733 or by email: [email protected]
FR Citation82 FR 44800 

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