81_FR_15789 81 FR 15732 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

81 FR 15732 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 81, Issue 57 (March 24, 2016)

Page Range15732-15733
FR Document2016-06592

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0406, scheduled to expire on April 30, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

Federal Register, Volume 81 Issue 57 (Thursday, March 24, 2016)
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15732-15733]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06592]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: HHS-OS-0990-0406 30D]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary (OS), Department of 
Health and Human Services, has submitted an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB) for review and approval. The ICR is for renewal of the approved 
information collection assigned OMB control number 0990-0406, scheduled 
to expire on April 30, 2016. Comments submitted during the first public 
review of this ICR will be provided to OMB. OMB will accept further 
comments from the public on this ICR during the review and approval 
period.

DATES: Comments on the ICR must be received on or before April 25, 
2016.

ADDRESSES: Submit your comments to [email protected] or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, [email protected] or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the OMB control number 0990-0406 for 
reference.
    Information Collection Request Title: Evaluation of the National 
Partnership for Action to End Health Disparities
    Abstract: Office of Minority Health (OMH) in the Office of the 
Assistant Secretary for Health (OASH), Office of the Secretary (OS) is 
requesting approval for an extension from the Office of Management and 
Budget (OMB) for a previously approved data collection activity for the 
Evaluation of the National Partnership for Action to End Health 
Disparities (NPA). The NPA was officially launched in April 2011 to 
mobilize a nationwide, comprehensive, community-driven, and sustained 
approach to combating health disparities and to move the nation toward 
achieving health equity. Using an approach that vests those at the 
front line with the responsibility of identifying and helping to shape 
core actions, new approaches and new partnerships are being established 
to help close the health gap in the United States.
    OMH proposes to continue to conduct the evaluation of the NPA. The 
evaluation's goal is to determine the extent to which the NPA has 
contributed to the elimination of health disparities and attainment of 
health

[[Page 15733]]

equity in our nation. The evaluation will accomplish this goal by 
addressing the following questions: (1) To what extent has a multi-
level structure been established to support actions that will 
contribute to the elimination of health disparities? (2) How are 
leaders in the public, private, nonprofit, and community sectors 
engaged in collaborative, efficient, and equitable working partnerships 
to eliminate health disparities? (3) How many and what types of 
identifiable actions are being implemented at the community, state, 
tribal, regional, and national levels that relate directly to the five 
goals and 20 strategies in the National Stakeholder Strategy (NSS); (4) 
How much is the work to end health disparities integrated into 
stakeholder strategies and mainstream systems (e.g., health care 
quality improvement, public and community health improvement, economic 
and community planning and development) in and beyond the health 
sector? (5) What are the promising practices for implementing actions 
that contribute to ending health disparities?

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                                         Average
                                                           Number of      Number of     burden per  Total burden
        Type of respondent                  Form          respondents   responses per    response       hours
                                                                         respondent     (minutes)
----------------------------------------------------------------------------------------------------------------
RHEC co-chairs....................  RHEC co-chairs                 20               1           85            28
                                     interview.
RHEC Subcommittee chairs..........  RHEC Subcommittee              50               1           90            75
                                     chairs group
                                     interviews.
RHEC members......................  Survey of all RHEC            350               1           20           117
                                     members.
Key NPA partner organizations.....  Survey of Key NPA              15               1           25             6
                                     partner
                                     organizations.
State Minority Health Office        Survey of State               110               1           20            37
 Directors or Coordinators and       Minority Health
 State Department of Health          Office Directors or
 Representatives.                    Coordinators and
                                     officials from
                                     State Departments
                                     of Health.
                                                         -------------------------------------------------------
    Total.........................  ....................          545  ..............  ...........           263
----------------------------------------------------------------------------------------------------------------


Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2016-06592 Filed 3-23-16; 8:45 am]
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                                                    15732                                   Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices

                                                    exclusion and an average of 2,160 hours
                                                    to prepare an EA.

                                                                                               TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
                                                                                                                                                                              Number of                                                Average
                                                                                                                                                   Number of                                            Total annual
                                                                                    21 CFR section                                                                          responses per                                            burden per              Total hours
                                                                                                                                                  respondents                                            responses
                                                                                                                                                                              respondent                                              response

                                                    25.15(a) and (d) ...................................................................                             70                         10                       700                         3              2,100
                                                    25.40(a) and (c) ...................................................................                             10                          1                        10                     2,160             21,600

                                                          Total ..............................................................................   ........................   ........................   ........................   ........................         23,700
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    Estimated Annual Reporting Burden for                                      demonstrate the substantial equivalence                                     approximately 532 respondents will
                                                    Tobacco Products                                                           of a new tobacco product (SEs) from 509                                     submit an average of 1 application for
                                                                                                                               respondents, 15 exemptions from                                             environmental assessment. Part of the
                                                      Under sections 905, 910, and 911 of                                      substantial equivalence requirements                                        information in the EA will be developed
                                                    the Federal Food, Drug, and Cosmetic                                       applications (SE Exemptions) from 15                                        while writing other parts of a PMTA,
                                                    Act (21 U.S.C. 387e, 387j, and 387k),                                      respondents, and 3 modified risk                                            SE, Exemption from SE, or MRTPA.
                                                    product applications and supplements                                       tobacco product applications (MRTPAs)                                       Based on FDA’s experience, previous
                                                    (PMTAs), SEs, Exemption from SEs, and                                      from 3 respondents. FDA is not                                              information provided by potential
                                                    modified risk tobacco products must                                        accepting claims for categorical                                            sponsors and knowledge that part of the
                                                    contain a claim for categorical exclusion                                  exclusions at this time, and estimates                                      EA information has already been
                                                    or an EA. In 2015, FDA estimated it will                                   that there will be 532 EAs from 532                                         produced in one of the tobacco product
                                                    receive approximately 5 premarket                                          respondents as required under                                               applications, FDA estimates that it takes
                                                    reviews of new tobacco PMTAs from 5                                        §§ 25.40(a) and (c). Therefore, over the                                    approximately 80 hours to prepare an
                                                    respondents, 509 reports intended to                                       next 3 years, FDA estimates that                                            EA.

                                                                                          TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
                                                                                                                                                                              Number of                                                Average
                                                                                                                                                   Number of                                            Total annual
                                                                                    21 CFR section                                                                          responses per                                            burden per              Total hours
                                                                                                                                                  respondents                                            responses
                                                                                                                                                                              respondent                                              response

                                                    25.40(a) and (c) ...................................................................                 532                          1                        532                         80                  42,560
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                      Dated: March 18, 2016.                                                   Management and Budget (OMB) for                                                Abstract: Office of Minority Health
                                                    Leslie Kux,                                                                review and approval. The ICR is for                                         (OMH) in the Office of the Assistant
                                                    Associate Commissioner for Policy.                                         renewal of the approved information                                         Secretary for Health (OASH), Office of
                                                    [FR Doc. 2016–06711 Filed 3–23–16; 8:45 am]                                collection assigned OMB control                                             the Secretary (OS) is requesting
                                                    BILLING CODE 4164–01–P
                                                                                                                               number 0990–0406, scheduled to expire                                       approval for an extension from the
                                                                                                                               on April 30, 2016. Comments submitted                                       Office of Management and Budget
                                                                                                                               during the first public review of this ICR                                  (OMB) for a previously approved data
                                                    DEPARTMENT OF HEALTH AND                                                   will be provided to OMB. OMB will                                           collection activity for the Evaluation of
                                                    HUMAN SERVICES                                                             accept further comments from the                                            the National Partnership for Action to
                                                                                                                               public on this ICR during the review                                        End Health Disparities (NPA). The NPA
                                                    Office of the Secretary                                                    and approval period.                                                        was officially launched in April 2011 to
                                                                                                                               DATES: Comments on the ICR must be                                          mobilize a nationwide, comprehensive,
                                                    [Document Identifier: HHS–OS–0990–0406                                                                                                                 community-driven, and sustained
                                                                                                                               received on or before April 25, 2016.
                                                    30D]                                                                                                                                                   approach to combating health
                                                                                                                               ADDRESSES: Submit your comments to
                                                                                                                                                                                                           disparities and to move the nation
                                                    Agency Information Collection                                              OIRA_submission@omb.eop.gov or via
                                                                                                                                                                                                           toward achieving health equity. Using
                                                    Activities; Submission to OMB for                                          facsimile to (202) 395–5806.
                                                                                                                                                                                                           an approach that vests those at the front
                                                    Review and Approval; Public Comment                                        FOR FURTHER INFORMATION CONTACT:                                            line with the responsibility of
                                                    Request                                                                    Information Collection Clearance staff,                                     identifying and helping to shape core
                                                    AGENCY:      Office of the Secretary, HHS.                                 Information.CollectionClearance@                                            actions, new approaches and new
                                                                                                                               hhs.gov or (202) 690–6162.                                                  partnerships are being established to
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    ACTION:      Notice.
                                                                                                                               SUPPLEMENTARY INFORMATION: When                                             help close the health gap in the United
                                                    SUMMARY:   In compliance with section                                      submitting comments or requesting                                           States.
                                                    3507(a)(1)(D) of the Paperwork                                             information, please include the OMB                                            OMH proposes to continue to conduct
                                                    Reduction Act of 1995, the Office of the                                   control number 0990–0406 for                                                the evaluation of the NPA. The
                                                    Secretary (OS), Department of Health                                       reference.                                                                  evaluation’s goal is to determine the
                                                    and Human Services, has submitted an                                         Information Collection Request Title:                                     extent to which the NPA has
                                                    Information Collection Request (ICR),                                      Evaluation of the National Partnership                                      contributed to the elimination of health
                                                    described below, to the Office of                                          for Action to End Health Disparities                                        disparities and attainment of health


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                                                                                          Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices                                                                                        15733

                                                    equity in our nation. The evaluation                                    working partnerships to eliminate                                      strategies and mainstream systems (e.g.,
                                                    will accomplish this goal by addressing                                 health disparities? (3) How many and                                   health care quality improvement, public
                                                    the following questions: (1) To what                                    what types of identifiable actions are                                 and community health improvement,
                                                    extent has a multi-level structure been                                 being implemented at the community,                                    economic and community planning and
                                                    established to support actions that will                                state, tribal, regional, and national levels                           development) in and beyond the health
                                                    contribute to the elimination of health                                 that relate directly to the five goals and                             sector? (5) What are the promising
                                                    disparities? (2) How are leaders in the                                 20 strategies in the National                                          practices for implementing actions that
                                                    public, private, nonprofit, and                                         Stakeholder Strategy (NSS); (4) How                                    contribute to ending health disparities?
                                                    community sectors engaged in                                            much is the work to end health
                                                    collaborative, efficient, and equitable                                 disparities integrated into stakeholder

                                                                                                                  TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                                 Average
                                                                                                                                                                                                      Number of
                                                                                                                                                                                      Number of                                burden per            Total burden
                                                                 Type of respondent                                                          Form                                                   responses per
                                                                                                                                                                                     respondents                                response                hours
                                                                                                                                                                                                      respondent                (minutes)

                                                    RHEC co-chairs .....................................          RHEC co-chairs interview .....................                              20                        1                     85               28
                                                    RHEC Subcommittee chairs ..................                   RHEC Subcommittee chairs group                                              50                        1                     90               75
                                                                                                                    interviews.
                                                    RHEC members .....................................            Survey of all RHEC members ...............                                 350                        1                    20               117
                                                    Key NPA partner organizations .............                   Survey of Key NPA partner organiza-                                         15                        1                    25                 6
                                                                                                                    tions.
                                                    State Minority Health Office Directors or                     Survey of State Minority Health Office                                     110                        1                    20                37
                                                      Coordinators and State Department                             Directors or Coordinators and offi-
                                                      of Health Representatives.                                    cials from State Departments of
                                                                                                                    Health.

                                                         Total ................................................   ................................................................           545   ........................   ....................            263



                                                    Terry S. Clark,                                                           Place: National Institutes of Health, 6701                             The meetings will be closed to the
                                                    Asst Information Collection Clearance                                   Rockledge Drive, Bethesda, MD 20892,                                   public in accordance with the
                                                    Officer.                                                                (Telephone Conference Call).                                           provisions set forth in sections
                                                    [FR Doc. 2016–06592 Filed 3–23–16; 8:45 am]                               Contact Person: Sara Ahlgren, Ph.D.,                                 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                                            Scientific Review Officer, Center for                                  as amended. The grant applications and
                                                    BILLING CODE 4150–29–P
                                                                                                                            Scientific Review, National Institutes of
                                                                                                                                                                                                   the discussions could disclose
                                                                                                                            Health, 6701 Rockledge Drive, RM 4136,
                                                                                                                                                                                                   confidential trade secrets or commercial
                                                                                                                            Bethesda, MD 20892, 301–435–0904,
                                                    DEPARTMENT OF HEALTH AND                                                                                                                       property such as patentable material,
                                                                                                                            sara.ahlgren@nih.gov.
                                                    HUMAN SERVICES                                                                                                                                 and personal information concerning
                                                                                                                              This notice is being published less than 15
                                                                                                                            days prior to the meeting due to the timing
                                                                                                                                                                                                   individuals associated with the grant
                                                    National Institutes of Health                                                                                                                  applications, the disclosure of which
                                                                                                                            limitations imposed by the review and
                                                                                                                            funding cycle.                                                         would constitute a clearly unwarranted
                                                    Center for Scientific Review; Notice of
                                                                                                                            (Catalogue of Federal Domestic Assistance
                                                                                                                                                                                                   invasion of personal privacy.
                                                    Closed Meeting
                                                                                                                            Program Nos. 93.306, Comparative Medicine;                               Name of Committee: National Heart, Lung,
                                                      Pursuant to section 10(d) of the                                      93.333, Clinical Research, 93.306, 93.333,                             and Blood Institute Special Emphasis
                                                    Federal Advisory Committee Act, as                                      93.337, 93.393–93.396, 93.837–93.844,                                  Panel—Basic Research in HIV-Related Heart,
                                                                                                                            93.846–93.878, 93.892, 93.893, National                                Lung, and Blood Diseases (R01) .
                                                    amended (5 U.S.C. App.), notice is
                                                                                                                            Institutes of Health, HHS)                                               Date: April 19, 2016.
                                                    hereby given of the following meeting.                                                                                                           Time: 8:00 a.m. to 1:00 p.m.
                                                      The meeting will be closed to the                                       Dated: March 18, 2016.                                                 Agenda: To review and evaluate grant
                                                    public in accordance with the                                           Anna Snouffer,                                                         applications.
                                                    provisions set forth in sections                                        Deputy Director, Office of Federal Advisory                              Place: Courtyard by Marriott, 5520
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                              Committee Policy.                                                      Wisconsin Avenue, Chevy Chase, MD 20815.
                                                                                                                                                                                                     Contact Person: Susan Wohler Sunnarborg,
                                                    as amended. The grant applications and                                  [FR Doc. 2016–06618 Filed 3–23–16; 8:45 am]                            Ph.D., Scientific Review Officer, Office of
                                                    the discussions could disclose                                          BILLING CODE 4140–01–P                                                 Scientific Review/DERA National, Heart,
                                                    confidential trade secrets or commercial                                                                                                       Lung, and Blood Institute, 6701 Rockledge
                                                    property such as patentable material,                                                                                                          Drive, Room 7182, Bethesda, MD 20892,
                                                    and personal information concerning                                     DEPARTMENT OF HEALTH AND                                               sunnarborgsw@nhlbi.nih.gov.
                                                    individuals associated with the grant                                   HUMAN SERVICES                                                           Name of Committee: National Heart, Lung,
                                                    applications, the disclosure of which                                                                                                          and Blood Institute Special Emphasis Panel
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    would constitute a clearly unwarranted                                  National Institutes of Health                                          Basic Research in HIV-Related Heart, Lung,
                                                    invasion of personal privacy.                                                                                                                  and Blood Diseases (R21).
                                                                                                                            National Heart, Lung, and Blood                                          Date: April 19, 2016.
                                                      Name of Committee: Center for Scientific                                                                                                       Time: 1:00 p.m. to 5:00 p.m.
                                                    Review Special Emphasis Panel; Member
                                                                                                                            Institute Notice of Closed Meetings
                                                                                                                                                                                                     Agenda: To review and evaluate grant
                                                    Conflicts: Cardiovascular Sciences.                                                                                                            applications.
                                                      Date: April 6, 2016.                                                    Pursuant to section 10(d) of the                                       Place: Courtyard by Marriott, 5520
                                                      Time: 11:30 a.m. to 3:30 p.m.                                         Federal Advisory Committee Act, as                                     Wisconsin Avenue, Chevy Chase, MD 20815.
                                                      Agenda: To review and evaluate grant                                  amended (5 U.S.C. App.), notice is                                       Contact Person: Susan Wohler Sunnarborg,
                                                    applications.                                                           hereby given of the following meetings.                                Ph.D., Scientific Review Officer, Office of



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Document Created: 2016-03-24 00:57:52
Document Modified: 2016-03-24 00:57:52
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 the ICR must be received on or before April 25, 2016.
ContactInformation Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation81 FR 15732 

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