81_FR_41677 81 FR 41554 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request

81 FR 41554 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 123 (June 27, 2016)

Page Range41554-41555
FR Document2016-15092

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

Federal Register, Volume 81 Issue 123 (Monday, June 27, 2016)
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41554-41555]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(HRSA) has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period.

DATES: Comments on this ICR should be received no later than July 27, 
2016.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at [email protected] or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Black Lung Clinics Program 
Performance Measures OMB No. 0915-0292-Extension
    Abstract: HRSA's Federal Office of Rural Health Policy (FORHP), 
conducts an annual data collection of information for the Black Lung 
Clinics Program, which has been ongoing with OMB approval since 2004. 
The Black Lung Clinics Program seeks to reduce the morbidity and 
mortality associated with occupationally-related coal mine dust lung 
disease. Collecting this data provides HRSA with information on the 
extent to which each grantee is meeting the needs of these miners in 
their communities.
    Need and Proposed Use of the Information: Data from the annual 
report provides quantitative information about the clinics, 
specifically: (a) The characteristics of the patients they serve 
(gender, age, disability level, occupation type); (b) the 
characteristics of services provided (medical encounters, non-medical 
encounters, benefits

[[Page 41555]]

counseling, and outreach); and, (c) the number of patients served. This 
assessment enables HRSA to provide data required by Congress under the 
Government Performance and Results Act of 1993. It also ensures that 
funds are effectively used to provide services that meet the target 
population needs. HRSA does not plan to make any changes to the 
performance measures at this time.
    Likely Respondents: Black Lung Clinics Program Grantees.
    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 verifying 
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 ICR 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
----------------------------------------------------------------------------------------------------------------
Black Lung Clinics Program                    15               1              15              10             150
 Measures.......................
                                 -------------------------------------------------------------------------------
    Total.......................              15  ..............              15  ..............             150
----------------------------------------------------------------------------------------------------------------


Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-15092 Filed 6-24-16; 8:45 am]
 BILLING CODE 4165-15-P



                                                  41554                          Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices

                                                  solely responsible for ensuring that your               copies to the Division of Dockets                      DEPARTMENT OF HEALTH AND
                                                  comment does not include any                            Management. If you do not wish your                    HUMAN SERVICES
                                                  confidential information that you or a                  name and contact information to be
                                                  third party may not wish to be posted,                  made publicly available, you can                       Health Resources and Services
                                                  such as medical information, your or                    provide this information on the cover                  Administration
                                                  anyone else’s Social Security number, or                sheet and not in the body of your
                                                  confidential business information, such                                                                        Agency Information Collection
                                                                                                          comments and you must identify this                    Activities: Submission to OMB for
                                                  as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any
                                                  that if you include your name, contact                                                                         Review and Approval; Public Comment
                                                                                                          information marked as ‘‘confidential’’                 Request
                                                  information, or other information that                  will not be disclosed except in
                                                  identifies you in the body of your                                                                             AGENCY: Health Resources and Services
                                                                                                          accordance with 21 CFR 10.20 and other
                                                  comments, that information will be                                                                             Administration, HHS.
                                                  posted on http://www.regulations.gov.                   applicable disclosure law. For more
                                                                                                          information about FDA’s posting of                     ACTION: Notice.
                                                    • If you want to submit a comment
                                                  with confidential information that you                  comments to public dockets, see 80 FR                  SUMMARY:    In compliance with section
                                                  do not wish to be made available to the                 56469, September 18, 2015, or access                   3507(a)(1)(D) of the Paperwork
                                                  public, submit the comment as a                         the information at: http://www.fda.gov/                Reduction Act of 1995, the Health
                                                  written/paper submission and in the                     regulatoryinformation/dockets/                         Resources and Services Administration
                                                  manner detailed (see ‘‘Written/Paper                    default.htm.                                           (HRSA) has submitted an Information
                                                  Submissions’’ and ‘‘Instructions’’).                       Docket: For access to the docket to                 Collection Request (ICR) to the Office of
                                                  Written/Paper Submissions                               read background documents or the                       Management and Budget (OMB) for
                                                                                                          electronic and written/paper comments                  review and approval. Comments
                                                     Submit written/paper submissions as                                                                         submitted during the first public review
                                                  follows:                                                received, go to http://
                                                                                                          www.regulations.gov and insert the                     of this ICR will be provided to OMB.
                                                     • Mail/Hand delivery/Courier (for
                                                                                                          docket number, found in brackets in the                OMB will accept further comments from
                                                  written/paper submissions): Division of
                                                                                                          heading of this document, into the                     the public during the review and
                                                  Dockets Management (HFA–305), Food
                                                                                                          ‘‘Search’’ box and follow the prompts                  approval period.
                                                  and Drug Administration, 5630 Fishers
                                                  Lane, Rm. 1061, Rockville, MD 20852.                    and/or go to the Division of Dockets                   DATES: Comments on this ICR should be
                                                     • For written/paper comments                         Management, 5630 Fishers Lane, Rm.                     received no later than July 27, 2016.
                                                  submitted to the Division of Dockets                    1061, Rockville, MD 20852.                             ADDRESSES: Submit your comments,
                                                  Management, FDA will post your                                                                                 including the ICR Title, to the desk
                                                                                                          FOR FURTHER INFORMATION CONTACT:                       officer for HRSA, either by email to
                                                  comment, as well as any attachments,
                                                  except for information submitted,                       Jeffrey Murray, Center for Drug                        OIRA_submission@omb.eop.gov or by
                                                  marked and identified, as confidential,                 Evaluation and Research, Food and                      fax to 202–395–5806.
                                                  if submitted as detailed in                             Drug Administration, 10903 New                         FOR FURTHER INFORMATION CONTACT: To
                                                  ‘‘Instructions.’’                                       Hampshire Ave., Bldg. 22, Rm. 6360,                    request a copy of the clearance requests
                                                     Instructions: All submissions received               Silver Spring, MD 20993–0002, 301–                     submitted to OMB for review, email the
                                                  must include the Docket No. FDA–                        796–1500.                                              HRSA Information Collection Clearance
                                                  2013–D–1170 for ‘‘Chronic Hepatitis C                   SUPPLEMENTARY INFORMATION:     In the                  Officer at paperwork@hrsa.gov or call
                                                  Virus Infection: Developing Direct-                     Federal Register of May 4, 2016 (81 FR                 (301) 443–1984.
                                                  Acting Antiviral Drugs for Treatment;                                                                          SUPPLEMENTARY INFORMATION:
                                                                                                          26805), FDA published a notice of
                                                  Draft Guidance for Industry.’’ Received                                                                          Information Collection Request Title:
                                                                                                          availability.
                                                  comments will be placed in the docket                                                                          Black Lung Clinics Program
                                                  and, except for those submitted as                         Interested persons were originally                  Performance Measures OMB No. 0915–
                                                  ‘‘Confidential Submissions,’’ publicly                  given until July 5, 2016, to comment on                0292–Extension
                                                  viewable at http://www.regulations.gov                  the draft guidance for industry entitled                 Abstract: HRSA’s Federal Office of
                                                  or at the Division of Dockets                           ‘‘Chronic Hepatitis C Virus Infection:                 Rural Health Policy (FORHP), conducts
                                                  Management between 9 a.m. and 4 p.m.,                   Developing Direct-Acting Antiviral                     an annual data collection of information
                                                  Monday through Friday.                                  Drugs for Treatment.’’                                 for the Black Lung Clinics Program,
                                                     • Confidential Submissions—To                           From July 1 through July 5, 2016, the               which has been ongoing with OMB
                                                  submit a comment with confidential                                                                             approval since 2004. The Black Lung
                                                                                                          Federal eRulemaking Portal, http://
                                                  information that you do not wish to be                                                                         Clinics Program seeks to reduce the
                                                                                                          www.regulations.gov, is undergoing
                                                  made publicly available, submit your                                                                           morbidity and mortality associated with
                                                  comments only as a written/paper                        maintenance. We are, therefore,
                                                                                                                                                                 occupationally-related coal mine dust
                                                  submission. You should submit two                       extending the comment period for the
                                                                                                                                                                 lung disease. Collecting this data
                                                  copies total. One copy will include the                 draft guidance for industry entitled                   provides HRSA with information on the
                                                  information you claim to be confidential                ‘‘Chronic Hepatitis C Virus Infection:                 extent to which each grantee is meeting
                                                  with a heading or cover note that states                Developing Direct-Acting Antiviral                     the needs of these miners in their
                                                  ‘‘THIS DOCUMENT CONTAINS                                Drugs for Treatment.’’ The extended                    communities.
                                                  CONFIDENTIAL INFORMATION.’’ The                         comment period will close on July 19,                    Need and Proposed Use of the
                                                  Agency will review this copy, including                 2016.                                                  Information: Data from the annual
mstockstill on DSK3G9T082PROD with NOTICES




                                                  the claimed confidential information, in                  Dated: June 21, 2016.                                report provides quantitative information
                                                  its consideration of comments. The                      Leslie Kux,
                                                                                                                                                                 about the clinics, specifically: (a) The
                                                  second copy, which will have the                                                                               characteristics of the patients they serve
                                                                                                          Associate Commissioner for Policy.
                                                  claimed confidential information                                                                               (gender, age, disability level, occupation
                                                  redacted/blacked out, will be available                 [FR Doc. 2016–15098 Filed 6–24–16; 8:45 am]            type); (b) the characteristics of services
                                                  for public viewing and posted on http://                BILLING CODE 4164–01–P                                 provided (medical encounters, non-
                                                  www.regulations.gov. Submit both                                                                               medical encounters, benefits


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                                                                                           Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices                                                                         41555

                                                  counseling, and outreach); and, (c) the                                     Likely Respondents: Black Lung                              information, processing and
                                                  number of patients served. This                                           Clinics Program Grantees.                                     maintaining information, and disclosing
                                                  assessment enables HRSA to provide                                          Burden Statement: Burden in this                            and providing information; to train
                                                  data required by Congress under the                                       context means the time expended by                            personnel and to be able to respond to
                                                  Government Performance and Results                                        persons to generate, maintain, retain,                        a collection of information; to search
                                                  Act of 1993. It also ensures that funds                                   disclose or provide the information                           data sources; to complete and review
                                                  are effectively used to provide services                                  requested. This includes the time                             the collection of information; and to
                                                  that meet the target population needs.                                    needed to review instructions; to                             transmit or otherwise disclose the
                                                  HRSA does not plan to make any                                            develop, acquire, install and utilize                         information. The total annual burden
                                                  changes to the performance measures at                                    technology and systems for the purpose                        hours estimated for this ICR are
                                                  this time.                                                                of collecting, validating and verifying                       summarized in the table below.

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

                                                  Black Lung Clinics Program Measures ...............................                                     15                         1            15                        10               150

                                                       Total ..............................................................................               15   ........................           15     ........................            150



                                                  Jason E. Bennett,                                                         Officer at paperwork@hrsa.gov or call                            To achieve the goals and objectives of
                                                  Director, Division of the Executive Secretariat.                          (301) 443–1984.                                               the program, the SCDTDP uses quality
                                                  [FR Doc. 2016–15092 Filed 6–24–16; 8:45 am]                                                                                             improvement (QI) methods in a
                                                                                                                            SUPPLEMENTARY INFORMATION:
                                                  BILLING CODE 4165–15–P                                                                                                                  collective impact model which supports
                                                                                                                               Information Collection Request Title:                      cross-sector collaboration for achieving
                                                                                                                            Sickle Cell Disease Treatment                                 measurable effects on major social
                                                  DEPARTMENT OF HEALTH AND                                                  Demonstration Program—Quality                                 issues. The collective impact model
                                                  HUMAN SERVICES                                                            Improvement Data Collection.                                  requires shared measurement which
                                                                                                                               OMB No.: 0906–xxxx–NEW.                                    facilitates tracking progress in a
                                                  Health Resources and Services                                                                                                           standardized method to promote
                                                                                                                               Abstract: In response to the growing
                                                  Administration                                                                                                                          learning and enhance continuous
                                                                                                                            need for resources and coordination of
                                                                                                                                                                                          improvement.
                                                  Agency Information Collection                                             resources devoted to sickle cell disease
                                                                                                                                                                                             Need and Proposed Use of the
                                                  Activities: Submission to OMB for                                         and other hemoglobinopathies, the
                                                                                                                                                                                          Information: The purpose of the
                                                  Review and Approval; Public Comment                                       United States Congress, under Section                         proposed data collection strategy is to
                                                  Request                                                                   712 of the American Jobs Creation Act                         implement a system to monitor the
                                                                                                                            of 2004 (Pub. L. 108–357) (42 U.S.C.                          progress of MCHB-funded activities in
                                                  AGENCY: Health Resources and Services                                     300b–1 note), authorized a                                    improving care and health outcomes for
                                                  Administration, HHS.                                                      demonstration program for the                                 individuals living with sickle cell
                                                  ACTION: Notice.                                                           prevention and treatment of sickle cell                       disease/trait and meeting the goals of
                                                                                                                            disease (SCD) to be administered by                           the SCDTDP. Each regional grantee site
                                                  SUMMARY:    In compliance with section                                    HRSA’s Maternal and Child Health                              will be asked to report on a core set of
                                                  3507(a)(1)(D) of the Paperwork                                            Bureau (MCHB) in the U.S. Department                          evidence-based measures related to
                                                  Reduction Act of 1995, the Health                                         of Health and Human Services. The                             healthcare utilization among
                                                  Resources and Services Administration                                     program is known as the Sickle Cell                           individuals with sickle cell disease and
                                                  (HRSA) has submitted an Information                                       Disease Treatment Demonstration                               the quality of care of the SCD
                                                  Collection Request (ICR) to the Office of                                 Program (SCDTDP). The SCDTDP is                               population.
                                                  Management and Budget (OMB) for                                           designed to improve access to services                           The data collected for the SCDTDP
                                                  review and approval. Comments                                             for individuals with sickle cell disease,                     will consist of administrative medical
                                                  submitted during the first public review                                  improve and expand patient and                                claims data collected from State
                                                  of this ICR will be provided to OMB.                                      provider education, and improve and                           Medicaid Programs and Medicaid
                                                  OMB will accept further comments from                                     expand the continuity and coordination                        Managed Care Organizations that
                                                  the public during the review and                                          of service delivery for individuals with                      administer Medicaid on behalf of states.
                                                  approval period.                                                          sickle cell disease and sickle cell trait.                    The data is collected either for or by
                                                  DATES: Comments on this ICR should be
                                                                                                                            The specific aims for the program are                         State Medicaid offices for delivery of
                                                  received no later than July 27, 2016.                                     threefold: (1) Increase the number of                         services subject to Medicaid
                                                                                                                            providers treating persons with sickle                        reimbursement.
                                                  ADDRESSES: Submit your comments,                                          cell disease, (2) increase the number of                         The data collection strategy will
                                                  including the ICR Title, to the desk                                      providers using evidence-based                                provide an effective and efficient
mstockstill on DSK3G9T082PROD with NOTICES




                                                  officer for HRSA, either by email to                                      treatments in sickle cell disease, such as                    mechanism to do the following: (1)
                                                  OIRA_submission@omb.eop.gov or by                                         prescribing hydroxyurea, and (3)                              Assess the improvements in access to
                                                  fax to 202–395–5806.                                                      increase the number of providers                              care for sickle cell patients provided by
                                                  FOR FURTHER INFORMATION CONTACT: To                                       knowledgeable about treating sickle cell                      activities in the SCDTDP; (2) collect,
                                                  request a copy of the clearance requests                                  disease and the number of sickle cell                         coordinate, and distribute data, best
                                                  submitted to OMB for review, email the                                    patients that are seen by providers                           practices, and findings from regional
                                                  HRSA Information Collection Clearance                                     knowledgeable about sickle cell disease.                      grantee sites to drive improvement on


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Document Created: 2016-06-25 02:06:44
Document Modified: 2016-06-25 02:06:44
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 ICR should be received no later than July 27, 2016.
ContactTo request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984.
FR Citation81 FR 41554 

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