Agency Information Collection Activities: Submission for OMB Review; Comment Request, 17555-17556 [2018-08329]
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
help to inform HHS, Exchanges, and
health insurance issuers as to the
participation of individuals, employers,
and employees in the individual
Exchange, and SHOP. Form Number:
CMS–10516 (OMB Control Number:
0938–1277); Frequency: Annually;
Affected Public: Private Sector, State,
Business, and Not-for Profits; Number of
Respondents: 1,915; Number of
Responses: 1,915; Total Annual Hours:
48,732. (For questions regarding this
collection, contact Leigha Basini at (301)
492–4380.)
Dated: April 17, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–08325 Filed 4–19–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10653]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
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 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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:44 Apr 19, 2018
Jkt 244001
Comments on the collection(s) of
information must be received by the
OMB desk officer by May 21, 2018.
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’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. 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
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: Revision 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
DATES:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
17555
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 selfcertification 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 selfinsured group health plan, the selfcertification 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.
Under the interim final regulations,
eligible organizations can revoke at any
time the accommodation process if
E:\FR\FM\20APN1.SGM
20APN1
17556
Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
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.
Final rules were published in the
Federal Register on July 14, 2015 (80 FR
41318) under which qualifying closely
held, for-profit entities may avail
themselves of the accommodation to
effectively exempt their plans from the
otherwise applicable requirement to
cover certain contraceptive services.
Previously, this accommodation had
been available only to non-profit eligible
organizations. These final rules also
finalized the 2014 interim final rules
permit an eligible organization to notify
HHS directly that it will not contract,
arrange, pay, or refer for all or a subset
of contraceptive services.
Due to judicial decisions
preliminarily enjoining the
implementation of the 2017 interim
final regulations, the information
collection requirements are drafted to be
applicable under whichever
accommodation rules are in effect (for
example, the 2017 interim final rules, or
the 2015 final rules if the 2017 interim
final rules continue to be enjoined).
HHS will only implement the ICRs
under regulations that are legally in
effect at the time the ICRs are used.
Form Number: CMS–10653 (OMB
control number: 0938–1344); Frequency:
On Occasion; Affected Public: Private
Sector; Number of Respondents: 110;
Number of Responses: 110; Total
Annual Hours: 181. (For policy
questions regarding this collection,
contact Usree Bandyopadhyay at 410–
786–6650.)
Dated: April 17, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–08329 Filed 4–19–18; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4120–01–P
VerDate Sep<11>2014
17:44 Apr 19, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1176]
Q7 Good Manufacturing Practice
Guidance for Active Pharmaceutical
Ingredients: Questions and Answers;
International Council for
Harmonisation; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Q7 Good
Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients:
Questions and Answers.’’ The guidance
was prepared under the auspices of the
International Council for Harmonisation
(ICH), formerly the International
Conference on Harmonisation. This
question and answer (Q&A) guidance
addresses questions about
implementation of FDA’s guidance ‘‘Q7
Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients’’
(ICH Q7). The Q&A guidance is
intended to clarify uncertainties due to
the interpretation of certain sections of
ICH Q7 and to help ensure that all
active pharmaceutical ingredients (APIs)
meet the standards for quality and
purity they purport or are represented to
possess.
DATES: The announcement of the
guidance is published in the Federal
Register on April 20, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
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Frm 00037
Fmt 4703
Sfmt 4703
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1176 for ‘‘Q7 Good
Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients:
Questions and Answers; International
Council for Harmonisation; Guidance
for Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
E:\FR\FM\20APN1.SGM
20APN1
Agencies
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17555-17556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08329]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10653]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Department of Health
and Human Services.
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 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.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by May 21, 2018.
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:
[email protected].
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' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. 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 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: Revision 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.
Under the interim final regulations, eligible organizations can
revoke at any time the accommodation process if
[[Page 17556]]
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.
Final rules were published in the Federal Register on July 14, 2015
(80 FR 41318) under which qualifying closely held, for-profit entities
may avail themselves of the accommodation to effectively exempt their
plans from the otherwise applicable requirement to cover certain
contraceptive services. Previously, this accommodation had been
available only to non-profit eligible organizations. These final rules
also finalized the 2014 interim final rules permit an eligible
organization to notify HHS directly that it will not contract, arrange,
pay, or refer for all or a subset of contraceptive services.
Due to judicial decisions preliminarily enjoining the
implementation of the 2017 interim final regulations, the information
collection requirements are drafted to be applicable under whichever
accommodation rules are in effect (for example, the 2017 interim final
rules, or the 2015 final rules if the 2017 interim final rules continue
to be enjoined). HHS will only implement the ICRs under regulations
that are legally in effect at the time the ICRs are used. Form Number:
CMS-10653 (OMB control number: 0938-1344); Frequency: On Occasion;
Affected Public: Private Sector; Number of Respondents: 110; Number of
Responses: 110; Total Annual Hours: 181. (For policy questions
regarding this collection, contact Usree Bandyopadhyay at 410-786-
6650.)
Dated: April 17, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-08329 Filed 4-19-18; 8:45 am]
BILLING CODE 4120-01-P