81_FR_37725 81 FR 37613 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

81 FR 37613 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37613-37614
FR Document2016-13735

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016)
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37613-37614]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
no later than August 9, 2016.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14A39, 5600 Fishers 
Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information collection request title 
for reference.
    Information Collection Request Title: National Practitioner Data 
Bank (NPDB) Attestation of Reports by Hospitals, Medical Malpractice 
Payers, Health Plans, and Health Centers.
    OMB No. 0915-xxxx--New.
    Abstract: The NPDB plans to collect data from hospitals, medical 
malpractice payers, health plans, and certain other health care 
entities \1\ that are subject to NPDB reporting requirements to assist 
these entities in understanding and meeting their reporting 
requirements to the NPDB. The NPDB currently collects similar data from 
state licensing boards on a regular basis, and this information 
collection request would expand beyond current reporting activities to 
include hospitals, medical malpractice payers, health plans, and 
certain health care entities.
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    \1\ Unless otherwise noted, the term ``health care entities'' 
refers to health centers whose access and reporting obligations are 
addressed in the NPDB statutory and regulatory requirements for 
health care entities. In this document, ``health center'' refers to 
organizations that receive grants under the HRSA Health Center 
Program as authorized under section 330 of the Public Health Service 
Act, as amended (referred to as ``grantees'') and Federally 
Qualified Health Center (FQHC) Look-Alike organizations, which meet 
all the Health Center Program requirements but do not receive Health 
Center Program grants. It does not refer to FQHCs that are sponsored 
by tribal or Urban Indian Health Organizations, except for those 
that receive Health Center Program grants.
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    The NPDB began operation on September 1, 1990. The statutory 
authorities establishing and governing the NPDB are title IV of Public 
Law (Pub. L.) 99-660, the Health Care Quality Improvement Act of 1986, 
as amended, section 5 of the Medicare and Medicaid Patient and Program 
Protection Act of 1987, Public Law 100-93, codified as section 1921 of 
the Social Security Act, and section 221(a) of the Health Insurance 
Portability and Accountability Act of 1996, Public Law 104-191, 
codified as section 1128E of the Social Security Act. Final regulations 
governing the NPDB are codified at 45 CFR part 60. Responsibility for 
NPDB implementation and operation resides in the Bureau of Health 
Workforce, Health Resources and Services Administration, Department of 
Health and Human Services (HHS).
    The NPDB acts primarily as a flagging system; its principal purpose 
is to facilitate comprehensive review of practitioners' professional 
credentials and background. Information on medical malpractice 
payments, health-related civil judgments, adverse licensure actions, 
adverse clinical privileging actions, adverse professional society 
actions, and Medicare/Medicaid exclusions is collected from and 
disseminated to eligible entities such as licensing boards, hospitals, 
and other health care entities. It is intended that NPDB information 
should be considered with other relevant information in evaluating a 
practitioner's credentials.
    The NPDB outlines specific reporting requirements for hospitals, 
medical malpractice payers, health plans, and health care entities; per 
45 CFR 60.7, 60.12, 60.14, 60.15, and 60.16. These reporting 
requirements are further explained in chapter E of the NPDB e-
Guidebook, which can be found at: http://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
    Through a process called Attestation, hospitals, medical 
malpractice payers, health plans, and certain other health entities 
will be required to attest that they understand and have met their 
responsibility to submit all required reports to the NPDB. The 
Attestation process will be completely automated through the secure 
NPDB system (https://www.npdb.hrsa.gov), using both secure email 
messaging and system notifications to alert entities registered with 
the NPDB of their responsibility to attest. All entities with reporting 
requirements and querying access to the NPDB must register with the 
NPDB before gaining access to the secure NPDB system for all reporting 
and querying transactions.
    Although the Attestation process and forms are new, the secure NPDB 
system currently used by hospitals, medical malpractice payers, health 
plans, and health care entities to conduct reporting and querying will 
not change, ensuring that these entities are familiar with the 
interface needed to complete the Attestation process. NPDB will ask 
these entities to attest their reporting compliance every 2 years. If 
the organization is responsible for privileging or credentialing 
individuals who provide services for other sites, those sites will be 
included in the Attestation process.
    The Attestation forms will collect the following information: (1) 
Information regarding sub-sites and entity relationships; (2) contact 
information for the Attesting Official; and (3) a statement attesting 
whether or not all required reports have been submitted.
    Need and Proposed Use of the Information: The NPDB engages in 
compliance activities to ensure the accuracy and completeness of the 
information in the NPDB. Through the Attestation process, the NPDB can 
better determine which hospitals, medical malpractice payers, health 
plans, and health care entities are meeting the reporting requirements, 
and which of

[[Page 37614]]

these entities may require additional outreach and assistance. The 
Attestation process will strengthen the robustness of the data in the 
NPDB, improving the accuracy of query responses for entities with 
access to NPDB reports.
    Likely Respondents: Hospitals medical malpractice payers, health 
plans, health care entities, and their representatives.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and attesting 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request are summarized in the table below.
    Total Estimated Annualized burden hours:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Health Care Entity Attestation..           3,000               1           3,000               1           3,000
Medical Malpractice Payer                    750               1             750               1             750
 Attestation....................
Health Plan Attestation.........           1,500               1           1,500               1           1,500
Hospital Attestation............           7,500               1           7,500               1           7,500
                                 -------------------------------------------------------------------------------
    Total.......................      \2\ 12,750  ..............          12,750  ..............          12,750
----------------------------------------------------------------------------------------------------------------

    HRSA specifically requests comments on (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.
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    \2\ There are approximately 6,800 hospitals, 575 medical 
malpractice payers, 1,400 health plans, and 2,200 health centers 
registered with the NPDB. However, the reporting entities may 
include multiple sites that are registered independently in the 
system, thereby increasing the total number of respondents. 
Therefore, we estimate there will be 7,500 respondents for 
hospitals, 750 respondents for medical malpractice payers, 1,500 
respondents for health plans, and 3,000 respondents for health 
centers for 12,750 total respondents.

Jason E. Bennett,
Director, Division of Executive Secretariat.
[FR Doc. 2016-13735 Filed 6-9-16; 8:45 am]
 BILLING CODE 4165-15-P



                                                                                    Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices                                             37613

                                                    resources with centers accessible to                       Information Collection Request Title:                exclusions is collected from and
                                                    each of the 10 HRSA regions.                            National Practitioner Data Bank (NPDB)                  disseminated to eligible entities such as
                                                    FOR FURTHER INFORMATION CONTACT:                        Attestation of Reports by Hospitals,                    licensing boards, hospitals, and other
                                                    Kathryn McLaughlin, MPH, Division of                    Medical Malpractice Payers, Health                      health care entities. It is intended that
                                                    Services for Children with Special                      Plans, and Health Centers.                              NPDB information should be considered
                                                    Health Needs, Maternal and Child                           OMB No. 0915–xxxx—New.                               with other relevant information in
                                                                                                               Abstract: The NPDB plans to collect                  evaluating a practitioner’s credentials.
                                                    Health Bureau, Health Resources and
                                                                                                            data from hospitals, medical                               The NPDB outlines specific reporting
                                                    Services Administration, 5600 Fishers
                                                                                                            malpractice payers, health plans, and                   requirements for hospitals, medical
                                                    Lane, Room 18W08, Rockville, MD
                                                                                                            certain other health care entities 1 that               malpractice payers, health plans, and
                                                    20852, Phone: (301) 443–6829, Email:
                                                                                                            are subject to NPDB reporting                           health care entities; per 45 CFR 60.7,
                                                    KMcLaughlin@hrsa.gov.
                                                                                                            requirements to assist these entities in                60.12, 60.14, 60.15, and 60.16. These
                                                      Dated: June 3, 2016.                                  understanding and meeting their                         reporting requirements are further
                                                    James Macrae,                                           reporting requirements to the NPDB.                     explained in chapter E of the NPDB e-
                                                    Acting Administrator.                                   The NPDB currently collects similar                     Guidebook, which can be found at:
                                                    [FR Doc. 2016–13784 Filed 6–9–16; 8:45 am]              data from state licensing boards on a                   http://www.npdb.hrsa.gov/resources/
                                                    BILLING CODE 4165–15–P                                  regular basis, and this information                     aboutGuidebooks.jsp.
                                                                                                            collection request would expand                            Through a process called Attestation,
                                                                                                            beyond current reporting activities to                  hospitals, medical malpractice payers,
                                                    DEPARTMENT OF HEALTH AND                                include hospitals, medical malpractice                  health plans, and certain other health
                                                    HUMAN SERVICES                                          payers, health plans, and certain health                entities will be required to attest that
                                                                                                            care entities.                                          they understand and have met their
                                                    Health Resources and Services                              The NPDB began operation on                          responsibility to submit all required
                                                    Administration                                          September 1, 1990. The statutory                        reports to the NPDB. The Attestation
                                                                                                            authorities establishing and governing                  process will be completely automated
                                                    Agency Information Collection                           the NPDB are title IV of Public Law                     through the secure NPDB system
                                                    Activities: Proposed Collection: Public                 (Pub. L.) 99–660, the Health Care                       (https://www.npdb.hrsa.gov), using both
                                                    Comment Request                                         Quality Improvement Act of 1986, as                     secure email messaging and system
                                                                                                            amended, section 5 of the Medicare and                  notifications to alert entities registered
                                                    AGENCY: Health Resources and Services                   Medicaid Patient and Program                            with the NPDB of their responsibility to
                                                    Administration, HHS.                                    Protection Act of 1987, Public Law 100–                 attest. All entities with reporting
                                                    ACTION: Notice.                                         93, codified as section 1921 of the                     requirements and querying access to the
                                                                                                            Social Security Act, and section 221(a)                 NPDB must register with the NPDB
                                                    SUMMARY:    In compliance with the                      of the Health Insurance Portability and                 before gaining access to the secure
                                                    requirement for opportunity for public                  Accountability Act of 1996, Public Law                  NPDB system for all reporting and
                                                    comment on proposed data collection                     104–191, codified as section 1128E of                   querying transactions.
                                                    projects (section 3506(c)(2)(A) of the                  the Social Security Act. Final                             Although the Attestation process and
                                                    Paperwork Reduction Act of 1995), the                   regulations governing the NPDB are                      forms are new, the secure NPDB system
                                                    Health Resources and Services                           codified at 45 CFR part 60.                             currently used by hospitals, medical
                                                    Administration (HRSA) announces                         Responsibility for NPDB                                 malpractice payers, health plans, and
                                                    plans to submit an Information                          implementation and operation resides                    health care entities to conduct reporting
                                                    Collection Request (ICR), described                     in the Bureau of Health Workforce,                      and querying will not change, ensuring
                                                    below, to the Office of Management and                  Health Resources and Services                           that these entities are familiar with the
                                                    Budget (OMB). Prior to submitting the                   Administration, Department of Health                    interface needed to complete the
                                                    ICR to OMB, HRSA seeks comments                         and Human Services (HHS).                               Attestation process. NPDB will ask these
                                                    from the public regarding the burden                       The NPDB acts primarily as a flagging                entities to attest their reporting
                                                    estimate, below, or any other aspect of                 system; its principal purpose is to                     compliance every 2 years. If the
                                                    the ICR.                                                facilitate comprehensive review of                      organization is responsible for
                                                    DATES: Comments on this Information                     practitioners’ professional credentials                 privileging or credentialing individuals
                                                    Collection Request must be received no                  and background. Information on                          who provide services for other sites,
                                                    later than August 9, 2016.                              medical malpractice payments, health-                   those sites will be included in the
                                                    ADDRESSES: Submit your comments to
                                                                                                            related civil judgments, adverse                        Attestation process.
                                                    paperwork@hrsa.gov or mail the HRSA                     licensure actions, adverse clinical                        The Attestation forms will collect the
                                                    Information Collection Clearance                        privileging actions, adverse professional               following information: (1) Information
                                                    Officer, Room 14A39, 5600 Fishers                       society actions, and Medicare/Medicaid                  regarding sub-sites and entity
                                                    Lane, Rockville, MD 20857.                                                                                      relationships; (2) contact information for
                                                                                                              1 Unless otherwise noted, the term ‘‘health care
                                                                                                                                                                    the Attesting Official; and (3) a
                                                    FOR FURTHER INFORMATION CONTACT: To                     entities’’ refers to health centers whose access and    statement attesting whether or not all
                                                    request more information on the                         reporting obligations are addressed in the NPDB
                                                                                                                                                                    required reports have been submitted.
                                                    proposed project or to obtain a copy of                 statutory and regulatory requirements for health
                                                                                                            care entities. In this document, ‘‘health center’’         Need and Proposed Use of the
                                                    the data collection plans and draft                                                                             Information: The NPDB engages in
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                                                                                                            refers to organizations that receive grants under the
                                                    instruments, email paperwork@hrsa.gov                   HRSA Health Center Program as authorized under          compliance activities to ensure the
                                                    or call the HRSA Information Collection                 section 330 of the Public Health Service Act, as
                                                                                                                                                                    accuracy and completeness of the
                                                    Clearance Officer at (301) 443–1984.                    amended (referred to as ‘‘grantees’’) and Federally
                                                                                                            Qualified Health Center (FQHC) Look-Alike               information in the NPDB. Through the
                                                    SUPPLEMENTARY INFORMATION: When                         organizations, which meet all the Health Center         Attestation process, the NPDB can better
                                                    submitting comments or requesting                       Program requirements but do not receive Health          determine which hospitals, medical
                                                                                                            Center Program grants. It does not refer to FQHCs
                                                    information, please include the                         that are sponsored by tribal or Urban Indian Health
                                                                                                                                                                    malpractice payers, health plans, and
                                                    information collection request title for                Organizations, except for those that receive Health     health care entities are meeting the
                                                    reference.                                              Center Program grants.                                  reporting requirements, and which of


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                                                    37614                                      Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices

                                                    these entities may require additional                                      persons to generate, maintain, retain,                       a collection of information; to search
                                                    outreach and assistance. The Attestation                                   disclose or provide the information                          data sources; to complete and review
                                                    process will strengthen the robustness                                     requested. This includes the time                            the collection of information; and to
                                                    of the data in the NPDB, improving the                                     needed to review instructions; to                            transmit or otherwise disclose the
                                                    accuracy of query responses for entities                                   develop, acquire, install and utilize                        information. The total annual burden
                                                    with access to NPDB reports.                                               technology and systems for the purpose                       hours estimated for this Information
                                                      Likely Respondents: Hospitals                                            of collecting, validating and attesting                      Collection Request are summarized in
                                                    medical malpractice payers, health                                         information, processing and                                  the table below.
                                                    plans, health care entities, and their
                                                                                                                               maintaining information, and disclosing                         Total Estimated Annualized burden
                                                    representatives.
                                                      Burden Statement: Burden in this                                         and providing information; to train                          hours:
                                                    context means the time expended by                                         personnel and to be able to respond to

                                                                                                                                                                                                                Average
                                                                                                                                                                    Number of
                                                                                                                                                  Number of                                    Total          burden per              Total burden
                                                                                       Form name                                                                  responses per
                                                                                                                                                 respondents                                responses          response                  hours
                                                                                                                                                                    respondent                                 (in hours)

                                                    Health Care Entity Attestation .............................................                        3,000                          1          3,000                         1            3,000
                                                    Medical Malpractice Payer Attestation ................................                                750                          1            750                         1              750
                                                    Health Plan Attestation ........................................................                    1,500                          1          1,500                         1            1,500
                                                    Hospital Attestation ..............................................................                 7,500                          1          7,500                         1            7,500

                                                          Total ..............................................................................       2 12,750    ........................        12,750    ........................         12,750



                                                      HRSA specifically requests comments                                      requesting nominations to fill vacancies                        The NACMH Charter requires that the
                                                    on (1) the necessity and utility of the                                    on the National Advisory Council on                          Council consist of 15 members, each
                                                    proposed information collection for the                                    Migrant Health (NACMH). The NACMH                            serving a 4-year term. Twelve Council
                                                    proper performance of the agency’s                                         is authorized under 42 U.S.C. 218,                           members are required to be governing
                                                    functions, (2) the accuracy of the                                         section 217 of the Public Health Service                     board members of migrant health
                                                    estimated burden, (3) ways to enhance                                      (PHS) Act, as amended and governed by                        centers and other entities assisted under
                                                    the quality, utility, and clarity of the                                   provisions of Public Law 92–463, as                          section 254(b) of the PHS Act. Of these
                                                    information to be collected, and (4) the                                   amended (5 U.S.C. Appendix 2).                               12, at least 9 must be patient board
                                                    use of automated collection techniques                                     DATES: The agency will receive                               members. The remaining three must be
                                                    or other forms of information                                              nominations on a continuous basis.                           individuals qualified by training and
                                                    technology to minimize the information                                     ADDRESSES: All nominations should be                         experience in the medical sciences or in
                                                    collection burden.                                                         addressed to the Designated Federal                          the administration of health programs.
                                                                                                                               Official, NACMH, Strategic Initiatives                       New members filling a vacancy that
                                                    Jason E. Bennett,
                                                                                                                               and Planning Division, Office of Policy                      occurred prior to expiration of a term
                                                    Director, Division of Executive Secretariat.                                                                                            may serve only for the remainder of
                                                    [FR Doc. 2016–13735 Filed 6–9–16; 8:45 am]
                                                                                                                               and Program Development, Bureau of
                                                                                                                               Primary Health Care, HRSA, 16N38B,                           such term. Members may serve after the
                                                    BILLING CODE 4165–15–P
                                                                                                                               5600 Fishers Lane, Rockville, Maryland                       expiration of their terms until their
                                                                                                                               20857 or via email to: Esther Paul at                        successors have taken office, but no
                                                                                                                               epaul@hrsa.gov and/or Priscilla Charles                      longer than 120 days.
                                                    DEPARTMENT OF HEALTH AND                                                                                                                   Compensation: Members who are not
                                                    HUMAN SERVICES                                                             at PCharles@hrsa.gov.
                                                                                                                                                                                            full-time Federal employees shall be
                                                                                                                               FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                                            paid at the rate of $200 per day
                                                    Health Resources and Services                                              Esther Paul, MBBS, MA, MPH,                                  including travel time plus per diem and
                                                    Administration                                                             Designated Federal Official, NACMH,                          travel expenses in accordance with
                                                                                                                               phone number: (301) 594–4496 or via                          Standard Government Travel
                                                    National Advisory Council on Migrant                                       email at epaul@hrsa.gov.
                                                    Health Request for Nominations for                                                                                                      Regulations.
                                                                                                                               SUPPLEMENTARY INFORMATION: As                                   Specifically, HRSA is requesting
                                                    Voting Members
                                                                                                                               authorized under section 217 of the                          nominations for:
                                                    AGENCY: Health Resources and Services                                      Public Health Service Act, as amended,                          • Board Member/Patient (1 vacancy):
                                                    Administration, HHS.                                                       42 U.S.C. 218, the Secretary established                        A nominee must be a member or
                                                    ACTION: Notice.                                                            the NACMH. The NACMH is governed                             member-elect of a governing board of an
                                                                                                                               by the Federal Advisory Committee Act                        organization receiving funding or look-
                                                    SUMMARY:  The Health Resources and                                         (5 U.S.C. Appendix 2), which sets forth                      alike designation under section 330(g) of
                                                    Services Administration (HRSA) is                                          standards for the formation and use of                       the PHS Act. A board member nominee
                                                                                                                               advisory committees.                                         must also be a patient of the entity that
                                                                                                                                  The NACMH, consults with and
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                      2 There are approximately 6,800 hospitals, 575
                                                                                                                                                                                            he/she represents. Additionally, a board
                                                    medical malpractice payers, 1,400 health plans, and                        makes recommendations to the                                 member nominee must be familiar with
                                                    2,200 health centers registered with the NPDB.
                                                    However, the reporting entities may include
                                                                                                                               Secretary of the Department of Health                        the delivery of primary health care to
                                                    multiple sites that are registered independently in                        and Human Services (HHS) and the                             migratory and seasonal agricultural
                                                    the system, thereby increasing the total number of                         HRSA Administrator concerning the                            workers (MSAWs) and their families.
                                                    respondents. Therefore, we estimate there will be                          organization, operation, selection, and                         • Administrator/Provider
                                                    7,500 respondents for hospitals, 750 respondents
                                                    for medical malpractice payers, 1,500 respondents
                                                                                                                               funding of migrant health centers and                        Representative (1 vacancy)
                                                    for health plans, and 3,000 respondents for health                         other entities under grants and contracts                       A nominee must be qualified by
                                                    centers for 12,750 total respondents.                                      under section 330 of the PHS Act.                            training and experience in the medical


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Document Created: 2018-02-08 07:35:41
Document Modified: 2018-02-08 07:35:41
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.
DatesComments on this Information Collection Request must be received no later than August 9, 2016.
ContactTo request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984.
FR Citation81 FR 37613 

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