80_FR_9766 80 FR 9730 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

80 FR 9730 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 36 (February 24, 2015)

Page Range9730-9731
FR Document2015-03650

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 80 Issue 36 (Tuesday, February 24, 2015)
[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9730-9731]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10407]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

ACTION: Notice.

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

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by March 26, 2015.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR Email: 
OIRA_submission@omb.eop.gov.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies

[[Page 9731]]

to publish a 30-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice that summarizes the 
following proposed collection(s) of information for public comment:
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Summary of 
Benefits and Coverage and Uniform Glossary; Use: Section 2715 of the 
PHS Act directs the Department of Health and Human Services (HHS), the 
Department of Labor (DOL), and the Department of the Treasury 
(collectively, the Departments), in consultation with the National 
Association of Insurance Commissioners (NAIC) and a working group 
comprised of stakeholders, to ``develop standards for use by a group 
health plan and a health insurance issuer in compiling and providing to 
applicants, enrollees, and policyholders and certificate holders a 
summary of benefits and coverage explanation that accurately describes 
the benefits and coverage under the applicable plan or coverage.'' To 
implement these disclosure requirements, collection of information 
requests relate to the provision of the following: Summary of benefits 
and coverage, which includes coverage examples; a uniform glossary of 
health coverage and medical terms; and a notice of modifications. Form 
Number: CMS-10407 (OMB control number 0938-1146); Frequency: Annual; 
Affected Public: Private Sector--Business or other for-profits and Not-
for-profit institutions; Number of Respondents: 126,500; Number of 
Responses: 41,153,858; Total Annual Hours: 322,411. (For policy 
questions regarding this collection, contact Heather Raeburn at 301-
492-4224.)

     Dated: February 18, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-03650 Filed 2-23-15; 8:45 am]
BILLING CODE 4120-01-P



                                              9730                        Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices

                                                 • The nominee’s contact information                  Report/. This form should not be                      concerning each proposed collection of
                                              and current occupation or position;                     submitted as part of a nomination.                    information, including each proposed
                                                 • The nominee’s resume or                            DATES: Nominations must be submitted                  extension or reinstatement of an existing
                                              curriculum vitae, including prior or                    (postmarked or electronically received)               collection of information, and to allow
                                              current membership on other National                    by March 31, 2015.                                    a second opportunity for public
                                              Institute for Occupational Safety and                      Submissions must be electronic or by               comment on the notice. Interested
                                              Health (NIOSH), CDC, or HHS advisory                    mail. Submissions should reference                    persons are invited to send comments
                                              committees or other relevant                            docket 229–C. Electronic submissions:                 regarding the burden estimate or any
                                              organizations, associations, and                        You may electronically submit                         other aspect of this collection of
                                              committees;                                             nominations, including attachments, to                information, including any of the
                                                 • The category of membership                         nioshdocket@cdc.gov. Attachments in                   following subjects: (1) The necessity and
                                              (epidemiologist, environmental                          Microsoft Word are preferred. Regular,                utility of the proposed information
                                              medicine or environmental health                        Express, or Overnight Mail: Written                   collection for the proper performance of
                                              specialist, occupational physician with                 nominations may be submitted (one                     the agency’s functions; (2) the accuracy
                                              experience treating WTC rescue and                      original and two copies) to the following             of the estimated burden; (3) ways to
                                              recovery workers, occupational                          address only: NIOSH Docket 229–C,                     enhance the quality, utility, and clarity
                                              physician, representative of WTC                        c/o Mia Wallace, Committee                            of the information to be collected; and
                                              responders, or toxicologist) that the                   Management Specialist, National                       (4) the use of automated collection
                                              candidate is qualified to represent;                    Institute for Occupational Safety and                 techniques or other forms of information
                                                 • A summary of the background,                       Health, Centers for Disease Control and               technology to minimize the information
                                              experience, and qualifications that                     Prevention, 1600 Clifton Rd. NE., MS:                 collection burden.
                                              demonstrates the nominee’s suitability                  E–20, Atlanta, Georgia 30333.                         DATES: Comments on the collection(s) of
                                              for the nominated membership category;                  Telephone and facsimile submissions                   information must be received by the
                                                 • Articles or other documents the                    cannot be accepted. For further                       OMB desk officer by March 26, 2015.
                                              nominee has authored that indicate the                  information contact: Paul Middendorf,                 ADDRESSES: When commenting on the
                                              nominee’s knowledge and experience in                   Senior Health Scientist, 1600 Clifton Rd.             proposed information collections,
                                              relevant subject categories; and                        NE., MS: E–20, Atlanta, GA 30333;                     please reference the document identifier
                                                 • A statement that the nominee is                    telephone (404) 498–2500 (this is not a               or OMB control number. To be assured
                                              aware of the nomination, is willing to                  toll-free number); email pmiddendorf@                 consideration, comments and
                                              regularly attend and participate in                     cdc.gov.                                              recommendations must be received by
                                              STAC meetings, and has no known                            The Director, Management Analysis                  the OMB desk officer via one of the
                                              conflicts of interest that would preclude               and Services Office, has been delegated               following transmissions: OMB, Office of
                                              membership on the Committee.                            the authority to sign Federal Register                Information and Regulatory Affairs,
                                                 STAC members will be selected upon                   notices pertaining to announcements of                Attention: CMS Desk Officer, Fax
                                              the basis of their relevant experience                  meetings and other committee                          Number: (202) 395–5806 OR Email:
                                              and competence in their respective                      management activities for both the                    OIRA_submission@omb.eop.gov.
                                              categorical fields. The information                     Centers for Disease Control and                          To obtain copies of a supporting
                                              received through this nomination                        Prevention and the Agency for Toxic                   statement and any related forms for the
                                              process, in addition to other relevant                  Substances and Disease Registry.                      proposed collection(s) summarized in
                                              sources of information, will assist the                                                                       this notice, you may make your request
                                                                                                      Elaine L. Baker,                                      using one of following:
                                              WTC Program Administrator in
                                              appointing members to serve on the                      Director, Management Analysis and Services               1. Access CMS’ Web site address at
                                                                                                      Office, Centers for Disease Control and               http://www.cms.hhs.gov/Paperwork
                                              STAC. In selecting members, the WTC                     Prevention.
                                              Program Administrator will consider                                                                           ReductionActof1995.
                                              individuals nominated in response to
                                                                                                      [FR Doc. 2015–03682 Filed 2–23–15; 8:45 am]              2. Email your request, including your
                                              this Federal Register notice as well as                 BILLING CODE P                                        address, phone number, OMB number,
                                              other qualified individuals.                                                                                  and CMS document identifier, to
                                                 The CDC is committed to bringing                                                                           Paperwork@cms.hhs.gov.
                                                                                                      DEPARTMENT OF HEALTH AND                                 3. Call the Reports Clearance Office at
                                              greater diversity of thought, perspective,
                                                                                                      HUMAN SERVICES                                        (410) 786–1326.
                                              and experience to its advisory
                                              committees. Nominees from all races,                                                                          FOR FURTHER INFORMATION CONTACT:
                                                                                                      Centers for Medicare & Medicaid
                                              genders, ages, and persons living with                                                                        Reports Clearance Office at (410) 786–
                                                                                                      Services
                                              disabilities are encouraged to apply.                                                                         1326.
                                              Nominees must be U.S. citizens.                         [Document Identifiers: CMS–10407]                     SUPPLEMENTARY INFORMATION: Under the
                                                 Candidates invited to serve will be                                                                        Paperwork Reduction Act of 1995 (PRA)
                                                                                                      Agency Information Collection
                                              asked to submit the ‘‘Confidential                                                                            (44 U.S.C. 3501–3520), federal agencies
                                                                                                      Activities: Submission for OMB
                                              Financial Disclosure Report,’’ OGE                                                                            must obtain approval from the Office of
                                                                                                      Review; Comment Request
                                              Form 450. This form is used by CDC to                                                                         Management and Budget (OMB) for each
                                              determine whether there is a financial                  ACTION:   Notice.                                     collection of information they conduct
                                              conflict between that person’s private                                                                        or sponsor. The term ‘‘collection of
                                              interests and activities and their public               SUMMARY:  The Centers for Medicare &                  information’’ is defined in 44 U.S.C.
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                                              responsibilities as a Special Government                Medicaid Services (CMS) is announcing                 3502(3) and 5 CFR 1320.3(c) and
                                              Employee as well as any appearance of                   an opportunity for the public to                      includes agency requests or
                                              a loss of impartiality, as defined by                   comment on CMS’ intention to collect                  requirements that members of the public
                                              Federal regulation. The form may be                     information from the public. Under the                submit reports, keep records, or provide
                                              viewed and downloaded at http://                        Paperwork Reduction Act of 1995                       information to a third party. Section
                                              www.oge.gov/Forms-Library/OGE-Form-                     (PRA), federal agencies are required to               3506(c)(2)(A) of the PRA (44 U.S.C.
                                              450-Confidential-Financial-Disclosure-                  publish notice in the Federal Register                3506(c)(2)(A)) requires federal agencies


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                                                                          Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices                                             9731

                                              to publish a 30-day notice in the                       DEPARTMENT OF HEALTH AND                              Toxin-Producing E. coli in Cattle.’’ The
                                              Federal Register concerning each                        HUMAN SERVICES                                        purpose of this document is to provide
                                              proposed collection of information,                                                                           recommendations to industry relating to
                                              including each proposed extension or                    Administration for Children and                       study design and describe criteria the
                                              reinstatement of an existing collection                 Families                                              Center for Veterinary Medicine (CVM)
                                              of information, before submitting the                                                                         thinks are the most appropriate for the
                                                                                                      [OMB No.: 0970–0139]
                                              collection to OMB for approval. To                                                                            evaluation of the effectiveness of new
                                              comply with this requirement, CMS is                    Uniform Project Description (UPD)                     animal drugs that are intended to reduce
                                              publishing this notice that summarizes                  Project Narrative Format for                          pathogenic Shiga toxin-producing E.
                                              the following proposed collection(s) of                 Discretionary Grant Application                       coli (STEC) in cattle.
                                              information for public comment:                         Forms; Correction                                     DATES: Although you can comment on
                                                1. Type of Information Collection                                                                           any guidance at any time (see 21 CFR
                                                                                                      AGENCY: Administration for Children                   10.115(g)(5)), to ensure that the Agency
                                              Request: Extension of a currently                       and Families, HHS.                                    considers your comment on this draft
                                              approved collection; Title of                           ACTION: Notice; correction.                           guidance before it begins work on the
                                              Information Collection: Summary of                                                                            final version of the guidance, submit
                                              Benefits and Coverage and Uniform                       SUMMARY:   The Administration for
                                                                                                                                                            either electronic or written comments
                                              Glossary; Use: Section 2715 of the PHS                  Children and Families published a
                                                                                                                                                            on the draft guidance by April 27, 2015.
                                              Act directs the Department of Health                    document in the Federal Register of
                                                                                                      February 17, 2015, concerning a request               ADDRESSES: Submit written requests for
                                              and Human Services (HHS), the
                                                                                                      for comments on a proposed                            single copies of the guidance to the
                                              Department of Labor (DOL), and the
                                                                                                      information collection. The document                  Communications Staff (HFV–12), Center
                                              Department of the Treasury
                                                                                                      contained an incorrect citation.                      for Veterinary Medicine, Food and Drug
                                              (collectively, the Departments), in
                                                                                                      FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                            Administration, 7519 Standish Pl.,
                                              consultation with the National                                                                                Rockville, MD 20855. Send one self-
                                              Association of Insurance Commissioners                  Christopher Beach, Senior Grants Policy
                                                                                                      Specialist, Division of Grants Policy,                addressed adhesive label to assist that
                                              (NAIC) and a working group comprised                                                                          office in processing your requests. See
                                              of stakeholders, to ‘‘develop standards                 Office of Administration,
                                                                                                      Administration for Children and                       the SUPPLEMENTARY INFORMATION section
                                              for use by a group health plan and a                                                                          for electronic access to the draft
                                              health insurance issuer in compiling                    Families, telephone (202) 401–1539.
                                                                                                         Correction: In the Federal Register of             guidance document.
                                              and providing to applicants, enrollees,                                                                          Submit electronic comments on the
                                                                                                      February 17, 2015, in FR. Doc. 2015–
                                              and policyholders and certificate                                                                             draft guidance to http://
                                                                                                      03144, on page 8324, in the third
                                              holders a summary of benefits and                                                                             www.regulations.gov. Submit written
                                                                                                      column, correct the last sentence of the
                                              coverage explanation that accurately                    ‘‘Description’’ caption to read:                      comments to the Division of Dockets
                                              describes the benefits and coverage                     ‘‘Guidance for the content of                         Management (HFA–305), Food and Drug
                                              under the applicable plan or coverage.’’                information requested in the Uniform                  Administration, 5630 Fishers Lane, Rm.
                                              To implement these disclosure                           Project Description is based in 45 CFR                1061, Rockville, MD 20852.
                                              requirements, collection of information                 75.203 and Appendix I to 45 CFR part                  FOR FURTHER INFORMATION CONTACT:
                                              requests relate to the provision of the                 75.’’                                                 Joshua R. Hayes, Center for Veterinary
                                              following: Summary of benefits and                                                                            Medicine (HFV–133), Food and Drug
                                              coverage, which includes coverage                       Christopher Beach,
                                                                                                                                                            Administration, 7500 Standish Pl.,
                                              examples; a uniform glossary of health                  Senior Grants Policy Specialist, Office of            Rockville, MD 20855, 240–402–0651,
                                                                                                      Administration.
                                              coverage and medical terms; and a                                                                             Joshua.hayes@fda.hhs.gov.
                                                                                                      [FR Doc. 2015–03627 Filed 2–23–15; 8:45 am]
                                              notice of modifications. Form Number:                                                                         SUPPLEMENTARY INFORMATION:
                                              CMS–10407 (OMB control number                           BILLING CODE 4184–01–P

                                              0938–1146); Frequency: Annual;                                                                                I. Background
                                              Affected Public: Private Sector—                                                                                 FDA is announcing the availability of
                                                                                                      DEPARTMENT OF HEALTH AND
                                              Business or other for-profits and Not-                  HUMAN SERVICES                                        a draft guidance for industry (GFI #229)
                                              for-profit institutions; Number of                                                                            entitled ‘‘Evaluating the Effectiveness of
                                              Respondents: 126,500; Number of                         Food and Drug Administration                          New Animal Drugs for the Reduction of
                                              Responses: 41,153,858; Total Annual                                                                           Pathogenic Shiga Toxin-Producing E.
                                              Hours: 322,411. (For policy questions                   [Docket No. FDA–2015–D–0235]                          coli in Cattle.’’ This draft guidance
                                              regarding this collection, contact                                                                            provides recommendations to industry
                                                                                                      Evaluating the Effectiveness of New
                                              Heather Raeburn at 301–492–4224.)                                                                             relating to study design and describes
                                                                                                      Animal Drugs for the Reduction of
                                                                                                                                                            criteria CVM thinks are the most
                                                 Dated: February 18, 2015.                            Pathogenic Shiga Toxin-Producing
                                                                                                                                                            appropriate for the evaluation of the
                                              William N. Parham, III,                                 Escherichia coli in Cattle; Draft
                                                                                                                                                            effectiveness of new animal drugs that
                                              Director, Paperwork Reduction Staff, Office             Guidance for Industry; Availability
                                                                                                                                                            are intended to reduce pathogenic STEC
                                              of Strategic Operations and Regulatory                  AGENCY:    Food and Drug Administration,              in cattle. It discusses general
                                              Affairs.                                                HHS.                                                  considerations regarding the
                                              [FR Doc. 2015–03650 Filed 2–23–15; 8:45 am]                                                                   development of protocols, study
                                                                                                      ACTION:   Notice.
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                                              BILLING CODE 4120–01–P                                                                                        conduct, animal welfare, substantial
                                                                                                      SUMMARY:   The Food and Drug                          evidence of effectiveness, experimental
                                                                                                      Administration (FDA) is announcing the                parameters, nutritional content of
                                                                                                      availability of a draft guidance for                  experimental diets, and the assessment
                                                                                                      industry (GFI #229) entitled ‘‘Evaluating             of drug concentrations in experimental
                                                                                                      the Effectiveness of New Animal Drugs                 diets. It also discusses the studies and
                                                                                                      for the Reduction of Pathogenic Shiga                 analyses CVM recommends for sponsors


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Document Created: 2015-12-18 13:23:30
Document Modified: 2015-12-18 13:23:30
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 collection(s) of information must be received by the OMB desk officer by March 26, 2015.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation80 FR 9730 

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