81_FR_42485 81 FR 42360 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Senior Medicare Patrol (SMP) Program National Beneficiary Survey

81 FR 42360 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Senior Medicare Patrol (SMP) Program National Beneficiary Survey

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living

Federal Register Volume 81, Issue 125 (June 29, 2016)

Page Range42360-42362
FR Document2016-15304

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from the public related to the Senior Medicare Patrol (SMP) Program. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 81 Issue 125 (Wednesday, June 29, 2016)
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42360-42362]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request; Senior Medicare Patrol (SMP) Program National 
Beneficiary Survey

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 ACL's intention to collect 
information from the public related to the Senior Medicare Patrol (SMP) 
Program. 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 or reinstatement of an existing collection of 
information) and to allow 60 days for public comment on the proposed 
action. Interested persons are invited to send comments regarding our 
burden estimates or any other aspect of

[[Page 42361]]

this collection of information, including any of the following 
subjects: (1) The necessity and utility of the proposed information 
collection for the proper performance of the agency's functions; (2) 
the accuracy of the estimated burden; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) the 
use of automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Submit written comments by on the collection of information by 
July 29, 2016.

ADDRESSES: Submit electronic comments on the collection of information 
to: [email protected]. Submit written comments on the 
collection of information to Katherine Glendening, Administration for 
Community Living, 330 C Street SW., Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Katherine Glendening 202-795-7350.

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 of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, ACL is publishing a notice of the proposed collection 
of information set forth in this document.
    Proposed Collection: Evaluation of the Senior Medicare Patrol (SMP) 
program, U.S. Department of Health and Human Services (HHS), 
Administration for Community Living (ACL).
    Need and Use of Information Collection: The SMP Customer 
Satisfaction Survey is a survey of individuals who attend Senior 
Medicare Patrol (SMP) presentations to understand the potential for 
fraud, waste, and abuse within health care programs generally, and 
Medicare/Medicaid specifically.
    The Senior Medicare Patrol Program (SMP) was created under Titles 
II and IV of the Older Americans Act, (42 U.S.C. 3032), the amendments 
of 2006 (Pub. L. 109-365) and the Health Insurance Portability and 
Accountability Act of 1996 (Pub. L. 104-191). The mission of the SMP 
program is to empower and assist Medicare beneficiaries, their 
families, and caregivers to prevent, detect, and report health care 
fraud, errors, and abuse through outreach, counseling, and education. 
The SMP program empowers Medicare beneficiaries through increased 
awareness and understanding of healthcare programs and helps them 
protect themselves from the economic and health-related consequences of 
Medicare fraud, waste, and abuse. The SMP program provides services 
through a national network of SMP grantees that are located in every 
state, the District of Columbia, Puerto Rico, and Guam. In 2014, SMPs 
conducted more than 14,000 education session presentations, with a 
total audience of 450,000 individuals.
    The SMP Customer Satisfaction Survey will focus on education 
session presentations and the individuals who attend them, to determine 
if the target audience is satisfied with the information they are 
receiving. While the SMP program currently tracks output and outcome 
measures such as number of SMP Team members, group outreach and 
education events, individual interactions and savings, customer 
satisfaction is not one of them. As a result, there is no current 
understanding of the link between the quality of the information 
received and the likelihood to avoid healthcare fraud, errors, and 
abuse.
    The SMP survey will be conducted over a three-year period beginning 
in Fiscal Year 2017 (FY17), with sites in each of the 50 states, the 
District of Columbia and the territories of Guam and Puerto Rico being 
surveyed once during the three-year period. Results from the surveys 
will be used to understand satisfaction among individuals who attend 
SMP education sessions, as well as how the program can be improved to 
provide better service to its target population.
    Eighteen (18) unique states will be surveyed in FY17, with each 
state expected to generate 75 unique responses, for a total of 1,350 
individual responses in Year 1. This process will then be replicated in 
Year 2 (FY18) and Year 3 (FY19), with a different group of 18 states 
and territories being surveyed each year. By the end of FY19, SMP will 
obtain 4,050 completed surveys to measure satisfaction at the state and 
national levels (18 states x 75 responses per state x 3 years). SMP 
will use the following factors to draw a representative sample of 
education session attendees:
     Randomly select 18 states and territories to be surveyed 
each year, with the states stratified by the average number of 
education session attendees per month.
     Survey a specific site no more than once.
     Sample from at least five presenters in each state.
     Survey no fewer than five events and no more than 20 
events in each state.
     Survey no more than two events per month in each state.
    To generate a sample with a 95% confidence level at the national 
level, a minimum of 400 responses will be required, which is based on 
over 450,000 education session attendees in 2014. SMP anticipates 
collecting 75 completed surveys per state, for a total collection of 
4,050 completed surveys. This larger collection will enable ACL to make 
state-to-state comparisons, which is an important feature of this 
survey. It will also provide each state with sufficient information to 
take local action to improve service within budgetary constraints.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The average annual burden associated 
with these activities is summarized below:

----------------------------------------------------------------------------------------------------------------
                                                                                                  Total average
         Respondent type              Number of      Responses per    Average burden hours per    annual burden
                                     respondents       respondent         response (hours)           (hours)
----------------------------------------------------------------------------------------------------------------
Stratified Random Sample.........           1,350                1   5 minutes.................           112.5
----------------------------------------------------------------------------------------------------------------



[[Page 42362]]

    Dated: June 21, 2016.
Kathy Greenlee,
Administrator and Assistant Secretary for Aging.
[FR Doc. 2016-15304 Filed 6-28-16; 8:45 am]
BILLING CODE 4151-01-P



                                                  42360                        Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices

                                                  in its efforts to implement Dodd-Frank                  the release of information obtained from                 Abstract: The mandatory reporting,
                                                  Wall Street Reform and Consumer                         small businesses would (1) impair the                  recordkeeping, and disclosure
                                                  Protection Act 3 that requires a national               Board’s ability to obtain this                         requirements regarding the closing of
                                                  hotline be established for appraisal                    information from entities that could not               any branch of an insured depository
                                                  related complaints.                                     be compelled to respond, and (2) cause                 institution are imposed by section 228
                                                    Current Actions: On April 4, 2016, the                substantial harm to the competitive                    of the Federal Deposit Insurance
                                                  Board published a notice in the Federal                 position of the entity from whom the                   Corporation Improvement Act of 1991
                                                  Register (81 FR 19181) requesting                       information was obtained (5 U.S.C.                     (FDICIA). There is no formal reporting
                                                  public comment for 60 days on the                       552(b)(4)). In addition, information                   form (the FR 4031 designation is for
                                                  proposal to extend for three years,                     obtained from consumers may be kept                    internal purposes only) associated with
                                                  without revision, the FR 1379. The                      confidential under exemption (b)(6) of                 the reporting portion of this information
                                                  comment period for this notice expired                  the FOIA because the information the                   collection; state member banks notify
                                                  on June 3, 2016. The Board did not                      survey collects is the type of                         the Federal Reserve Banks by letter prior
                                                  receive any comments, and the                           information that would constitute a                    to closing a branch. The Board uses the
                                                  information collection will be extended                 clearly unwarranted invasion of                        information to fulfill its statutory
                                                  as proposed.                                            personal privacy (Id. at 552(b)(6)).                   obligation to supervise state member
                                                    2. Report title: Survey to Obtain                        Abstract: The Board uses this                       banks.
                                                  Information on the Relevant Market in                   information to define relevant banking                   Current Actions: On April 4, 2016, the
                                                  Individual Merger Cases.                                markets for specific merger and                        Board published a notice in the Federal
                                                    Agency form number: FR 2060.                          acquisition applications and to evaluate               Register (81 FR 19181) requesting
                                                    OMB control number: 7100–0232.                        changes in competition that would                      public comment for 60 days on the
                                                    Frequency: On occasion.                               result from proposed transactions,                     proposal to extend for three years,
                                                    Reporters: Small businesses and                       including purchase and assumption                      without revision, the FR 4031. The
                                                  consumers.                                              agreements. The event-generated survey                 comment period for this notice expired
                                                    Estimated annual burden hours: 9                      is conducted by telephone and has been                 on June 3, 2016. The Board did not
                                                  hours.                                                  used no more than once per year since                  receive any comments, and the
                                                    Estimated average hours per response:                 1990.                                                  information collection will be extended
                                                  Small businesses: 10 minutes;                              Current Actions: On April 4, 2016, the              as proposed.
                                                  Consumers: 6 minutes.                                   Board published a notice in the Federal                  Board of Governors of the Federal Reserve
                                                    Number of respondents: Small                          Register (81 FR 19181) requesting                      System, June 23, 2016.
                                                  businesses: 25; Consumers: 50.                          public comment for 60 days on the                      Robert deV. Frierson,
                                                    General description of report: The FR                 proposal to extend for three years,                    Secretary of the Board.
                                                  2060 is voluntary and authorized                        without revision, the FR 2060. The                     [FR Doc. 2016–15326 Filed 6–28–16; 8:45 am]
                                                  pursuant to the Change In Bank Control                  comment period for this notice expired                 BILLING CODE 6210–01–P
                                                  Act (12 U.S.C. 1817(j)(7)(A) and (B)), the              on June 3, 2016. The Board did not
                                                  Bank Merger Act (12 U.S.C. 1828(c)(5)),                 receive any comments, and the
                                                  and section 3(c)(1) of the Bank Holding                 information collection will be extended                DEPARTMENT OF HEALTH AND
                                                  Company Act (12 U.S.C. 1842(c)(1)).                     as proposed.                                           HUMAN SERVICES
                                                  Each of these sections require the Board                   3. Report title: Notice of Branch
                                                  to evaluate merger and acquisition                      Closure.                                               Administration for Community Living
                                                  applications by banks and bank holding                     Agency form number: FR 4031.
                                                  companies to determine the effects of                      OMB control number: 7100–0264.                      Agency Information Collection
                                                  proposed transactions on competition in                    Frequency: On occasion.                             Activities; Proposed Collection; Public
                                                  a particular banking market. In order to                   Reporters: State member banks.                      Comment Request; Senior Medicare
                                                  make this determination, the Board                         Estimated annual burden hours: 247                  Patrol (SMP) Program National
                                                  must determine the relevant market and                  hours.                                                 Beneficiary Survey
                                                  then determine the level of competition                    Estimated average hours per response:               AGENCY:  Administration for Community
                                                  in the market. This survey provides the                 Reporting requirements: 2 hours;                       Living, HHS.
                                                  data necessary to make such                             Disclosure requirements, customer                      ACTION: Notice.
                                                  determinations when the Board                           mailing: 0.75 hours and posted notice,
                                                  otherwise would not have such                           0.25 hours; and Recordkeeping                          SUMMARY:   The Administration for
                                                  information.                                            requirements: 8 hours.                                 Community Living (ACL) is announcing
                                                    Information obtained from small                          Number of respondents: Reporting                    an opportunity for the public to
                                                  business and individuals may be kept                    requirements: 82; Disclosure                           comment on ACL’s intention to collect
                                                  confidential under the Freedom of                       requirements: customer mailing, 82 and                 information from the public related to
                                                  Information Act (FOIA). Information                     posted notice, 82; and Recordkeeping                   the Senior Medicare Patrol (SMP)
                                                  obtained from small businesses can be                   requirements, 0.                                       Program. Under the Paperwork
                                                  considered confidential under                              General description of report: This                 Reduction Act of 1995 (the PRA),
                                                  exemption (b)(4) of the FOIA because                    information collection is mandatory                    federal agencies are required to publish
                                                                                                          pursuant to Section 42(a)(1) of the                    a notice in the Federal Register
                                                  subcommittee, the ASC is funded by fees collected       Federal Deposit Insurance Act (FDI Act)                concerning each proposed collection of
mstockstill on DSK3G9T082PROD with NOTICES




                                                  through the registry. The ASC board has seven
                                                  members, one from each of these agencies: OCC,          (12 U.S.C. 1831r–l(a)(1)). The Board                   information (including each proposed
                                                  FRB, FDIC, NCUA, CFPB, FHFA and U.S.                    does not consider individual respondent                extension or reinstatement of an existing
                                                  Department of Housing and Urban Development             data to be confidential. However, a state              collection of information) and to allow
                                                  (HUD). The ASC Web site may be found at                 member bank may request confidential                   60 days for public comment on the
                                                  www.asc.gov/Home.aspx
                                                    3 Dodd-Frank Wall Street Reform and Consumer          treatment pursuant to exemption b(4) of                proposed action. Interested persons are
                                                  Protection Act § 1473, Pub. L. 111–203, 124 Stat.       the Freedom of Information Act (5                      invited to send comments regarding our
                                                  1376, July 21, 2010.                                    U.S.C.552(b)(4)).                                      burden estimates or any other aspect of


                                             VerDate Sep<11>2014   17:18 Jun 28, 2016   Jkt 238001   PO 00000   Frm 00053   Fmt 4703   Sfmt 4703   E:\FR\FM\29JNN1.SGM   29JNN1


                                                                                    Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices                                                              42361

                                                  this collection of information, including                         Satisfaction Survey is a survey of                          during the three-year period. Results
                                                  any of the following subjects: (1) The                            individuals who attend Senior Medicare                      from the surveys will be used to
                                                  necessity and utility of the proposed                             Patrol (SMP) presentations to                               understand satisfaction among
                                                  information collection for the proper                             understand the potential for fraud,                         individuals who attend SMP education
                                                  performance of the agency’s functions;                            waste, and abuse within health care                         sessions, as well as how the program
                                                  (2) the accuracy of the estimated                                 programs generally, and Medicare/                           can be improved to provide better
                                                  burden; (3) ways to enhance the quality,                          Medicaid specifically.                                      service to its target population.
                                                  utility, and clarity of the information to                           The Senior Medicare Patrol Program                          Eighteen (18) unique states will be
                                                  be collected; and (4) the use of                                  (SMP) was created under Titles II and IV                    surveyed in FY17, with each state
                                                  automated collection techniques or                                of the Older Americans Act, (42 U.S.C.                      expected to generate 75 unique
                                                  other forms of information technology to                          3032), the amendments of 2006 (Pub. L.                      responses, for a total of 1,350 individual
                                                  minimize the information collection                               109–365) and the Health Insurance                           responses in Year 1. This process will
                                                  burden.                                                           Portability and Accountability Act of                       then be replicated in Year 2 (FY18) and
                                                                                                                    1996 (Pub. L. 104–191). The mission of                      Year 3 (FY19), with a different group of
                                                  DATES: Submit written comments by on
                                                                                                                    the SMP program is to empower and                           18 states and territories being surveyed
                                                  the collection of information by July 29,
                                                                                                                    assist Medicare beneficiaries, their                        each year. By the end of FY19, SMP will
                                                  2016.
                                                                                                                    families, and caregivers to prevent,                        obtain 4,050 completed surveys to
                                                  ADDRESSES: Submit electronic                                      detect, and report health care fraud,
                                                  comments on the collection of                                                                                                 measure satisfaction at the state and
                                                                                                                    errors, and abuse through outreach,                         national levels (18 states × 75 responses
                                                  information to: Katherine.Glendening@                             counseling, and education. The SMP
                                                  acl.hhs.gov. Submit written comments                                                                                          per state × 3 years). SMP will use the
                                                                                                                    program empowers Medicare                                   following factors to draw a
                                                  on the collection of information to                               beneficiaries through increased
                                                  Katherine Glendening, Administration                                                                                          representative sample of education
                                                                                                                    awareness and understanding of                              session attendees:
                                                  for Community Living, 330 C Street                                healthcare programs and helps them
                                                  SW., Washington, DC 20024.                                                                                                       • Randomly select 18 states and
                                                                                                                    protect themselves from the economic                        territories to be surveyed each year,
                                                  FOR FURTHER INFORMATION CONTACT:                                  and health-related consequences of                          with the states stratified by the average
                                                  Katherine Glendening 202–795–7350.                                Medicare fraud, waste, and abuse. The                       number of education session attendees
                                                  SUPPLEMENTARY INFORMATION: Under the                              SMP program provides services through                       per month.
                                                  PRA (44 U.S.C. 3501–3520), Federal                                a national network of SMP grantees that                        • Survey a specific site no more than
                                                  agencies must obtain approval from the                            are located in every state, the District of                 once.
                                                  Office of Management and Budget                                   Columbia, Puerto Rico, and Guam. In
                                                  (OMB) for each collection of                                                                                                     • Sample from at least five presenters
                                                                                                                    2014, SMPs conducted more than
                                                  information they conduct or sponsor.                                                                                          in each state.
                                                                                                                    14,000 education session presentations,
                                                  ‘‘Collection of information’’ is defined                          with a total audience of 450,000                               • Survey no fewer than five events
                                                  in 44 U.S.C. 3502(3) and 5 CFR                                    individuals.                                                and no more than 20 events in each
                                                  1320.3(c) and includes agency requests                               The SMP Customer Satisfaction                            state.
                                                  or requirements that members of the                               Survey will focus on education session                         • Survey no more than two events per
                                                  public submit reports, keep records, or                           presentations and the individuals who                       month in each state.
                                                  provide information to a third party.                             attend them, to determine if the target                        To generate a sample with a 95%
                                                  Section 3506(c)(2)(A) of the PRA (44                              audience is satisfied with the                              confidence level at the national level, a
                                                  U.S.C. 3506(c)(2)(A)) requires Federal                            information they are receiving. While                       minimum of 400 responses will be
                                                  agencies to provide a 60-day notice in                            the SMP program currently tracks                            required, which is based on over
                                                  the Federal Register concerning each                              output and outcome measures such as                         450,000 education session attendees in
                                                  proposed collection of information,                               number of SMP Team members, group                           2014. SMP anticipates collecting 75
                                                  including each proposed extension of an                           outreach and education events,                              completed surveys per state, for a total
                                                  existing collection of information,                               individual interactions and savings,                        collection of 4,050 completed surveys.
                                                  before submitting the collection to OMB                           customer satisfaction is not one of them.                   This larger collection will enable ACL to
                                                  for approval. To comply with this                                 As a result, there is no current                            make state-to-state comparisons, which
                                                  requirement, ACL is publishing a notice                           understanding of the link between the                       is an important feature of this survey. It
                                                  of the proposed collection of                                     quality of the information received and                     will also provide each state with
                                                  information set forth in this document.                           the likelihood to avoid healthcare fraud,                   sufficient information to take local
                                                     Proposed Collection: Evaluation of the                         errors, and abuse.                                          action to improve service within
                                                  Senior Medicare Patrol (SMP) program,                                The SMP survey will be conducted                         budgetary constraints.
                                                  U.S. Department of Health and Human                               over a three-year period beginning in                          OMB approval is requested for 3
                                                  Services (HHS), Administration for                                Fiscal Year 2017 (FY17), with sites in                      years. There are no costs to respondents
                                                  Community Living (ACL).                                           each of the 50 states, the District of                      other than their time. The average
                                                     Need and Use of Information                                    Columbia and the territories of Guam                        annual burden associated with these
                                                  Collection: The SMP Customer                                      and Puerto Rico being surveyed once                         activities is summarized below:

                                                                                                                                                                                                Average
                                                                                                                                                                           Responses                                 Total average
                                                                                                                                                        Number of                             burden hours
                                                                                       Respondent type                                                                         per                                   annual burden
                                                                                                                                                       respondents                            per response
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                           respondent                                   (hours)
                                                                                                                                                                                                 (hours)

                                                  Stratified Random Sample ........................................................................        1,350               1           5 minutes .............      112.5




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                                                  42362                        Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices

                                                    Dated: June 21, 2016.                                 confidential business information, such                sheet and not in the body of your
                                                  Kathy Greenlee,                                         as a manufacturing process. Please note                comments and you must identify this
                                                  Administrator and Assistant Secretary for               that if you include your name, contact                 information as ‘‘confidential.’’ Any
                                                  Aging.                                                  information, or other information that                 information marked as ‘‘confidential’’
                                                  [FR Doc. 2016–15304 Filed 6–28–16; 8:45 am]             identifies you in the body of your                     will not be disclosed except in
                                                  BILLING CODE 4151–01–P                                  comments, that information will be                     accordance with 21 CFR 10.20 and other
                                                                                                          posted on http://www.regulations.gov.                  applicable disclosure law. For more
                                                                                                            • If you want to submit a comment                    information about FDA’s posting of
                                                  DEPARTMENT OF HEALTH AND                                with confidential information that you                 comments to public dockets, see 80 FR
                                                  HUMAN SERVICES                                          do not wish to be made available to the                56469, September 18, 2015, or access
                                                                                                          public, submit the comment as a                        the information at: http://www.fda.gov/
                                                  Food and Drug Administration                            written/paper submission and in the                    regulatoryinformation/dockets/
                                                  [Docket No. FDA–2016–N–1660]                            manner detailed (see ‘‘Written/Paper                   default.htm.
                                                                                                          Submissions’’ and ‘‘Instructions’’).                      Docket: For access to the docket to
                                                  Microbiology Devices Panel of the                       Written/Paper Submissions                              read background documents or the
                                                  Medical Devices Advisory Committee;                                                                            electronic and written/paper comments
                                                  Notice of Meeting; Establishment of a                      Submit written/paper submissions as                 received, go to http://
                                                  Public Docket; Request for Comments                     follows:                                               www.regulations.gov and insert the
                                                                                                             • Mail/Hand delivery/Courier (for                   docket number, found in brackets in the
                                                  AGENCY:    Food and Drug Administration,                written/paper submissions): Division of                heading of this document, into the
                                                  HHS.                                                    Dockets Management (HFA–305), Food
                                                                                                                                                                 ‘‘Search’’ box and follow the prompts
                                                  ACTION: Notice; establishment of a                      and Drug Administration, 5630 Fishers
                                                                                                                                                                 and/or go to the Division of Dockets
                                                  public docket; request for comments.                    Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                             • For written/paper comments                        Management, 5630 Fishers Lane, Rm.
                                                  SUMMARY:   The Food and Drug                            submitted to the Division of Dockets                   1061, Rockville, MD 20852.
                                                  Administration (FDA) announces a                        Management, FDA will post your                         FOR FURTHER INFORMATION CONTACT:
                                                  forthcoming public advisory committee                   comment, as well as any attachments,                   Shanika Craig, Center for Devices and
                                                  meeting of the Microbiology Devices                     except for information submitted,                      Radiological Health, Food and Drug
                                                  Panel of the Medical Devices Advisory                   marked and identified, as confidential,                Administration, 10903 New Hampshire
                                                  Committee. The general function of the                  if submitted as detailed in                            Ave., Bldg. 66, Rm. 1613, Silver Spring,
                                                  committee is to provide advice and                      ‘‘Instructions.’’                                      MD 20993–0002, 301–796–6639,
                                                  recommendations to the Agency on                           Instructions: All submissions received              Shanika.Craig@fda.hhs.gov, or FDA
                                                  FDA’s regulatory issues. The meeting                    must include the Docket No. FDA–                       Advisory Committee Information Line,
                                                  will be open to the public. FDA is                      2016–N–1660 for ‘‘Microbiology Devices                 1–800–741–8138 (301–443–0572 in the
                                                  establishing a docket for public                        Panel of the Medical Devices Advisory                  Washington, DC area). A notice in the
                                                  comment on this document.                               Committee; Notice of Meeting;                          Federal Register about last minute
                                                  DATES: The meeting will be held on                      Establishment of a Public Docket;                      modifications that impact a previously
                                                  August 16, 2016, from 8 a.m. to 6 p.m.                  Request for Comments.’’ Received                       announced advisory committee meeting
                                                  ADDRESSES: FDA White Oak Campus,                        comments will be placed in the docket                  cannot always be published quickly
                                                  10903 New Hampshire Ave., Bldg. 31                      and, except for those submitted as                     enough to provide timely notice.
                                                  Conference Center, the Great Room (Rm.                  ‘‘Confidential Submissions,’’ publicly                 Therefore, you should always check the
                                                  1503), Silver Spring, MD 20993–0002.                    viewable at http://www.regulations.gov                 Agency’s Web site at http://www.fda.
                                                  Answers to commonly asked questions                     or at the Division of Dockets                          gov/AdvisoryCommittees/default.htm
                                                  including information regarding special                 Management between 9 a.m. and 4 p.m.,                  and scroll down to the appropriate
                                                  accommodations due to a disability,                     Monday through Friday.                                 advisory committee meeting link, or call
                                                  visitor parking, and transportation may                    • Confidential Submissions—To                       the advisory committee information line
                                                  be accessed at: http://www.fda.gov/                     submit a comment with confidential                     to learn about possible modifications
                                                  AdvisoryCommittees/                                     information that you do not wish to be                 before coming to the meeting.
                                                  AboutAdvisoryCommittees/                                made publicly available, submit your                   SUPPLEMENTARY INFORMATION:
                                                  ucm408555.htm. You may submit                           comments only as a written/paper                          Agenda: On August 16, 2016, the
                                                  comments as follows:                                    submission. You should submit two                      committee will discuss and make
                                                                                                          copies total. One copy will include the                recommendations regarding the
                                                  Electronic Submissions                                  information you claim to be confidential               appropriateness of clearing or approving
                                                    Submit electronic comments in the                     with a heading or cover note that states               of over-the-counter (OTC) diagnostic
                                                  following way:                                          ‘‘THIS DOCUMENT CONTAINS                               tests for the detection of pathogens
                                                    • Federal eRulemaking Portal: http://                 CONFIDENTIAL INFORMATION.’’ The                        causing infectious diseases, focusing on
                                                  www.regulations.gov. Follow the                         Agency will review this copy, including                respiratory and sexually transmitted
                                                  instructions for submitting comments.                   the claimed confidential information, in               infections (STI). Currently, there are no
                                                  Comments submitted electronically,                      its consideration of comments. The                     OTC diagnostic tests for infectious
                                                  including attachments, to http://                       second copy, which will have the                       diseases cleared or approved by CDRH.
                                                  www.regulations.gov will be posted to                   claimed confidential information                       The committee will evaluate the risks
                                                  the docket unchanged. Because your                      redacted/blacked out, will be available                and benefits to individual patients and
mstockstill on DSK3G9T082PROD with NOTICES




                                                  comment will be made public, you are                    for public viewing and posted on http://               to public health associated with clearing
                                                  solely responsible for ensuring that your               www.regulations.gov. Submit both                       or approving OTC diagnostic tests for
                                                  comment does not include any                            copies to the Division of Dockets                      infectious diseases. Serious risks such
                                                  confidential information that you or a                  Management. If you do not wish your                    as false negative results, false positive
                                                  third party may not wish to be posted,                  name and contact information to be                     results, patient loss to medical
                                                  such as medical information, your or                    made publicly available, you can                       followup, and the impact on
                                                  anyone else’s Social Security number, or                provide this information on the cover                  surveillance of reportable infections will


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Document Created: 2018-02-08 07:42:40
Document Modified: 2018-02-08 07:42:40
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 comments by on the collection of information by July 29, 2016.
ContactKatherine Glendening 202-795-7350.
FR Citation81 FR 42360 

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