82_FR_52058 82 FR 51843 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 51843 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 215 (November 8, 2017)

Page Range51843-51844
FR Document2017-24305

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 82 Issue 215 (Wednesday, November 8, 2017)
[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51843-51844]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10653]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of

[[Page 51844]]

information technology to minimize the information collection burden.

DATES: Comments must be received by January 8, 2018.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10653 Coverage of Certain Preventive Services Under the Affordable 
Care Act

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. 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 requires federal agencies 
to publish a 60-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.
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Coverage of 
Certain Preventive Services Under the Affordable Care Act; Use: The 
2017 interim final regulations titled ``Religious Exemptions and 
Accommodations for Coverage of Certain Preventive Services Under the 
Affordable Care Act'' and ``Moral Exemptions and Accommodations for 
Coverage of Certain Preventive Services Under the Affordable Care Act'' 
expand exemptions for religious beliefs and moral convictions for 
certain entities or individuals whose health plans may otherwise be 
subject to a mandate of contraceptive coverage through guidance issued 
pursuant to the Patient Protection and Affordable Care Act. The interim 
final rules extend the exemption to health insurance issuers that hold 
religious or moral objections in certain circumstances. The interim 
final rules also allow plan participants and enrollees with sincerely 
held religious or moral objections to request coverage that does not 
include contraceptive services.
    The interim final rules also leave the accommodation process in 
place as an optional process for objecting entities who wish to use it 
voluntarily. To avoid contracting, arranging, paying, or referring for 
contraceptive coverage, an organization seeking to be treated as an 
eligible organization may self-certify (by using EBSA Form 700), prior 
to the beginning of the first plan year to which an accommodation is to 
apply, that it meets the definition of an eligible organization. The 
eligible organization must provide a copy of its self-certification to 
each health insurance issuer that would otherwise provide such coverage 
in connection with the health plan (for insured group health plans or 
student health insurance coverage). The issuer that receives the self-
certification must provide separate payments for contraceptive services 
for plan participants and beneficiaries (or students and dependents). 
For a self-insured group health plan, the self-certification must be 
provided to its third party administrator. An eligible organization may 
alternatively submit a notification to HHS as an alternative to 
submitting the EBSA Form 700 to the eligible organization's health 
insurance issuer or third party administrator. A health insurance 
issuer or third party administrator providing or arranging payments for 
contraceptive services for participants and beneficiaries in plans (or 
student enrollees and covered dependents in student health insurance 
coverage) of eligible organizations must provide a written notice to 
such plan participants and beneficiaries (or such student enrollees and 
covered dependents) informing them of the availability of such 
payments.
    Eligible organizations can revoke at any time the accommodation 
process if participants and beneficiaries receive written notice of 
such revocation from the issuer or third party administrator in 
accordance with guidance issued by the Secretary, and if the 
accommodation process is currently being utilized, such revocation will 
be effective on the first day of the first plan year that begins on or 
after thirty days after the date of revocation. Form Number: CMS-10653 
(OMB control number 0938-1344); Frequency: On Occasion; Affected 
Public: Private Sector; Number of Respondents: 110; Number of 
Responses: 274,629; Total Annual Hours: 181. (For policy questions 
regarding this collection contact Usree Bandyopadhyay at 410-786-6650. 
For all other issues call (410) 786-1326.)

    Dated: November 3, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-24305 Filed 11-7-17; 8:45 am]
 BILLING CODE 4120-01-P



                                                                        Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices                                             51843

                                               use of appropriate automated,                           Background and Brief Description                      jurisdictions will participate in the
                                               electronic, mechanical, or other                          The Risk Assessment, Mapping, and                   interview and focus groups.
                                               technological collection techniques or                  Planning (RAMP) tool is currently being                  CDC will offer Los Angeles
                                               other forms of information technology,                  developed by CDC for public health and                Department of Public Health Clinic
                                               e.g., permitting electronic submission of
                                                                                                       medical emergency planners (especially                guests the Community Emergency
                                               responses; and
                                                                                                       Public Health Emergency Preparedness                  Preparedness Survey in order to
                                                 (e) Assess information collection
                                               costs.                                                  and Hospital Preparedness Program                     determine community perspectives on
                                                 To request additional information on                  awardees) to assess and quantify risk,                several emergency preparedness and
                                               the proposed project or to obtain a copy                identify and map at-risk populations,                 response topics. CDC will offer the
                                               of the information collection plan and                  and to determine response objectives for              Community Emergency Preparedness
                                               instruments, call (404) 639–7570 or                     hazard-specific public health emergency               Survey anonymously to three separate
                                               send an email to omb@cdc.gov. Direct                    plans at all jurisdictional levels in the             types of community members: LA
                                               written comments and/or suggestions                     United States.                                        County Public Health Center Clients, LA
                                               regarding the items contained in this                     To assist in developing this tool, CDC              County Community Partner
                                               notice to the Attention: CDC Desk                       will conduct key informant interviews/                Stakeholders, and LA County
                                               Officer, Office of Management and                       focus groups with public health and                   Community Residents.
                                               Budget, 725 17th Street NW.,                            emergency management professionals
                                                                                                       from across the United States. To                        CDC will collect information with the
                                               Washington, DC 20503 or by fax to (202)
                                               395–5806. Provide written comments                      understand the needs of at-risk                       use of paper surveys. CDC will enter the
                                               within 30 days of notice publication.                   populations, CDC will also administer                 information from the paper survey into
                                                                                                       an anonymous survey to respondents                    a secured database. CDC will lock all
                                               Proposed Project                                        from Los Angeles County Department of                 paper surveys in the secure offices of
                                                 Who’s at Risk: From Hazards to                        Public Health clinics.                                the Los Angeles County Department of
                                               Communities—An Approach for                               CDC seeks to obtain subject matter                  Public Health Emergency Preparedness
                                               Operationalizing CDC Guidelines to                      expertise and feedback for pilot testing              and Response Division. CDC will
                                               Determine Risks, and Define, Locate,                    the RAMP tool and anonymous                           disseminate and report results in
                                               and Reach At-Risk Populations in                        demographic information from LA                       aggregate form only. The total number of
                                               Public Health Emergencies—New—                          County DPH clinic guests. CDC will use                estimated annual burden hours is 226.
                                               Office of Public Health Preparedness                    the data to develop the RAMP tool.                    There are no costs to the respondents
                                               and Response (OPHPR), Centers for                         Public health and emergency manager                 other than their time.
                                               Disease Control and Prevention (CDC).                   respondents in pre-identified partner

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

                                               Public Health and Medical Emergency Plan-             Focus Group Questionnaire ..........................             100               1                 1
                                                 ners.
                                               LA County Public Health Center Guests .......         Community Emergency Preparedness Sur-                            500               1           5/60
                                                                                                       vey.
                                               LA County Community Partner Stakeholders              Community Emergency Preparedness Sur-                            500               1           5/60
                                                                                                       vey.
                                               LA County Community Residents ..................      Community Emergency Preparedness Sur-                            500               1           5/60
                                                                                                       vey.



                                               Leroy A. Richardson,                                    DEPARTMENT OF HEALTH AND                              PRA), federal agencies are required to
                                               Chief, Information Collection Review Office,            HUMAN SERVICES                                        publish notice in the Federal Register
                                               Office of Scientific Integrity, Office of the                                                                 concerning each proposed collection of
                                               Associate Director for Science, Office of the           Centers for Medicare & Medicaid                       information (including each proposed
                                               Director, Centers for Disease Control and               Services                                              extension or reinstatement of an existing
                                               Prevention.                                                                                                   collection of information) and to allow
                                                                                                       [Document Identifier: CMS–10653]
                                               [FR Doc. 2017–24313 Filed 11–7–17; 8:45 am]                                                                   60 days for public comment on the
                                               BILLING CODE 4163–18–P                                  Agency Information Collection                         proposed action. Interested persons are
                                                                                                       Activities: Proposed Collection;                      invited to send comments regarding our
                                                                                                       Comment Request                                       burden estimates or any other aspect of
                                                                                                       AGENCY: Centers for Medicare &                        this collection of information, including
                                                                                                       Medicaid Services, HHS.                               the necessity and utility of the proposed
                                                                                                       ACTION: Notice.                                       information collection for the proper
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                                                                                                                                                             performance of the agency’s functions,
                                                                                                       SUMMARY:  The Centers for Medicare &                  the accuracy of the estimated burden,
                                                                                                       Medicaid Services (CMS) is announcing                 ways to enhance the quality, utility, and
                                                                                                       an opportunity for the public to                      clarity of the information to be
                                                                                                       comment on CMS’ intention to collect                  collected, and the use of automated
                                                                                                       information from the public. Under the                collection techniques or other forms of
                                                                                                       Paperwork Reduction Act of 1995 (the


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                                               51844                    Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices

                                               information technology to minimize the                  Section 3506(c)(2)(A) of the PRA                      notification to HHS as an alternative to
                                               information collection burden.                          requires federal agencies to publish a                submitting the EBSA Form 700 to the
                                               DATES: Comments must be received by                     60-day notice in the Federal Register                 eligible organization’s health insurance
                                               January 8, 2018.                                        concerning each proposed collection of                issuer or third party administrator. A
                                               ADDRESSES: When commenting, please                      information, including each proposed                  health insurance issuer or third party
                                               reference the document identifier or                    extension or reinstatement of an existing             administrator providing or arranging
                                               OMB control number. To be assured                       collection of information, before                     payments for contraceptive services for
                                               consideration, comments and                             submitting the collection to OMB for                  participants and beneficiaries in plans
                                               recommendations must be submitted in                    approval. To comply with this                         (or student enrollees and covered
                                               any one of the following ways:                          requirement, CMS is publishing this                   dependents in student health insurance
                                                 1. Electronically. You may send your                  notice.                                               coverage) of eligible organizations must
                                                                                                          1. Type of Information Collection                  provide a written notice to such plan
                                               comments electronically to http://
                                                                                                       Request: Extension of a currently                     participants and beneficiaries (or such
                                               www.regulations.gov. Follow the
                                                                                                       approved collection; Title of                         student enrollees and covered
                                               instructions for ‘‘Comment or
                                                                                                       Information Collection: Coverage of                   dependents) informing them of the
                                               Submission’’ or ‘‘More Search Options’’
                                                                                                       Certain Preventive Services Under the                 availability of such payments.
                                               to find the information collection
                                                                                                       Affordable Care Act; Use: The 2017                       Eligible organizations can revoke at
                                               document(s) that are accepting
                                                                                                       interim final regulations titled                      any time the accommodation process if
                                               comments.
                                                                                                       ‘‘Religious Exemptions and                            participants and beneficiaries receive
                                                 2. By regular mail. You may mail
                                                                                                       Accommodations for Coverage of                        written notice of such revocation from
                                               written comments to the following
                                                                                                       Certain Preventive Services Under the                 the issuer or third party administrator in
                                               address: CMS, Office of Strategic
                                                                                                       Affordable Care Act’’ and ‘‘Moral                     accordance with guidance issued by the
                                               Operations and Regulatory Affairs,
                                                                                                       Exemptions and Accommodations for                     Secretary, and if the accommodation
                                               Division of Regulations Development,
                                                                                                       Coverage of Certain Preventive Services               process is currently being utilized, such
                                               Attention: Document Identifier/OMB                      Under the Affordable Care Act’’ expand                revocation will be effective on the first
                                               Control Number __, Room C4–26–05,                       exemptions for religious beliefs and                  day of the first plan year that begins on
                                               7500 Security Boulevard, Baltimore,                     moral convictions for certain entities or             or after thirty days after the date of
                                               Maryland 21244–1850.                                    individuals whose health plans may                    revocation. Form Number: CMS–10653
                                                 To obtain copies of a supporting                      otherwise be subject to a mandate of                  (OMB control number 0938–1344);
                                               statement and any related forms for the                 contraceptive coverage through                        Frequency: On Occasion; Affected
                                               proposed collection(s) summarized in                    guidance issued pursuant to the Patient               Public: Private Sector; Number of
                                               this notice, you may make your request                  Protection and Affordable Care Act. The               Respondents: 110; Number of
                                               using one of following:                                 interim final rules extend the exemption              Responses: 274,629; Total Annual
                                                 1. Access CMS’ Web site address at                    to health insurance issuers that hold                 Hours: 181. (For policy questions
                                               http://www.cms.hhs.gov/                                 religious or moral objections in certain              regarding this collection contact Usree
                                               PaperworkReductionActof1995.                            circumstances. The interim final rules                Bandyopadhyay at 410–786–6650. For
                                                 2. Email your request, including your                 also allow plan participants and                      all other issues call (410) 786–1326.)
                                               address, phone number, OMB number,                      enrollees with sincerely held religious
                                               and CMS document identifier, to                                                                                  Dated: November 3, 2017.
                                                                                                       or moral objections to request coverage
                                               Paperwork@cms.hhs.gov.                                                                                        William N. Parham, III,
                                                                                                       that does not include contraceptive
                                                 3. Call the Reports Clearance Office at               services.                                             Director, Paperwork Reduction Staff, Office
                                               (410) 786–1326.                                                                                               of Strategic Operations and Regulatory
                                                                                                          The interim final rules also leave the
                                               FOR FURTHER INFORMATION CONTACT:                                                                              Affairs.
                                                                                                       accommodation process in place as an
                                               William Parham at (410) 786–4669.                                                                             [FR Doc. 2017–24305 Filed 11–7–17; 8:45 am]
                                                                                                       optional process for objecting entities
                                                                                                       who wish to use it voluntarily. To avoid              BILLING CODE 4120–01–P
                                               SUPPLEMENTARY INFORMATION:
                                                                                                       contracting, arranging, paying, or
                                               Contents                                                referring for contraceptive coverage, an
                                                 This notice sets out a summary of the                                                                       DEPARTMENT OF HEALTH AND
                                                                                                       organization seeking to be treated as an
                                               use and burden associated with the                      eligible organization may self-certify (by            HUMAN SERVICES
                                               following information collections. More                 using EBSA Form 700), prior to the                    Food and Drug Administration
                                               detailed information can be found in                    beginning of the first plan year to which
                                               each collection’s supporting statement                  an accommodation is to apply, that it                 [Docket No. FDA–2016–D–1504]
                                               and associated materials (see                           meets the definition of an eligible
                                               ADDRESSES).                                             organization. The eligible organization               Recurrent Herpes Labialis: Developing
                                                                                                       must provide a copy of its self-                      Drugs for Treatment and Prevention;
                                               CMS–10653 Coverage of Certain                                                                                 Guidance for Industry; Availability
                                                                                                       certification to each health insurance
                                               Preventive Services Under the
                                                                                                       issuer that would otherwise provide                   AGENCY:   Food and Drug Administration,
                                               Affordable Care Act
                                                                                                       such coverage in connection with the                  HHS.
                                                 Under the PRA (44 U.S.C. 3501–                        health plan (for insured group health                 ACTION:   Notice of availability.
                                               3520), federal agencies must obtain                     plans or student health insurance
                                               approval from the Office of Management                  coverage). The issuer that receives the               SUMMARY:  The Food and Drug
                                               and Budget (OMB) for each collection of                 self-certification must provide separate              Administration (FDA or Agency) is
ethrower on DSK3G9T082PROD with NOTICES




                                               information they conduct or sponsor.                    payments for contraceptive services for               announcing the availability of a
                                               The term ‘‘collection of information’’ is               plan participants and beneficiaries (or               guidance for industry entitled
                                               defined in 44 U.S.C. 3502(3) and 5 CFR                  students and dependents). For a self-                 ‘‘Recurrent Herpes Labialis: Developing
                                               1320.3(c) and includes agency requests                  insured group health plan, the self-                  Drugs for Treatment and Prevention.’’
                                               or requirements that members of the                     certification must be provided to its                 The purpose of this guidance is to assist
                                               public submit reports, keep records, or                 third party administrator. An eligible                sponsors in all phases of development
                                               provide information to a third party.                   organization may alternatively submit a               of treatments for recurrent herpes


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Document Created: 2017-11-08 01:20:30
Document Modified: 2017-11-08 01:20:30
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 must be received by January 8, 2018.
ContactWilliam Parham at (410) 786-4669.
FR Citation82 FR 51843 

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