83 FR 17555 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 77 (April 20, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17555-17556 | |
| FR Document | 2018-08329 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Notices] [Pages 17555-17556] From the Federal Register Online [www.thefederalregister.org] [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
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help to inform HHS, Exchanges, and DATES: Comments on the collection(s) of Accommodations for Coverage of
health insurance issuers as to the information must be received by the Certain Preventive Services Under the
participation of individuals, employers, OMB desk officer by May 21, 2018. Affordable Care Act’’ and ‘‘Moral
and employees in the individual ADDRESSES: When commenting on the Exemptions and Accommodations for
Exchange, and SHOP. Form Number: proposed information collections, Coverage of Certain Preventive Services
CMS–10516 (OMB Control Number: please reference the document identifier Under the Affordable Care Act’’ expand
0938–1277); Frequency: Annually; or OMB control number. To be assured exemptions for religious beliefs and
Affected Public: Private Sector, State, consideration, comments and moral convictions for certain entities or
Business, and Not-for Profits; Number of recommendations must be received by individuals whose health plans may
Respondents: 1,915; Number of the OMB desk officer via one of the otherwise be subject to a mandate of
Responses: 1,915; Total Annual Hours: following transmissions: OMB, Office of contraceptive coverage through
48,732. (For questions regarding this Information and Regulatory Affairs, guidance issued pursuant to the Patient
collection, contact Leigha Basini at (301) Attention: CMS Desk Officer, Fax Protection and Affordable Care Act. The
492–4380.) Number: (202) 395–5806 OR, Email: interim final rules extend the exemption
Dated: April 17, 2018. OIRA_submission@omb.eop.gov. to health insurance issuers that hold
To obtain copies of a supporting religious or moral objections in certain
William N. Parham, III,
statement and any related forms for the circumstances. The interim final rules
Director, Paperwork Reduction Staff, Office also allow plan participants and
of Strategic Operations and Regulatory proposed collection(s) summarized in
this notice, you may make your request enrollees with sincerely held religious
Affairs.
using one of following: or moral objections to request coverage
[FR Doc. 2018–08325 Filed 4–19–18; 8:45 am]
1. Access CMS’ website address at that does not include contraceptive
BILLING CODE 4120–01–P services.
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/ The interim final rules also leave the
PaperworkReductionActof1995/PRA- accommodation process in place as an
DEPARTMENT OF HEALTH AND optional process for objecting entities
HUMAN SERVICES Listing.html.
1. Email your request, including your who wish to use it voluntarily. To avoid
address, phone number, OMB number, contracting, arranging, paying, or
Centers for Medicare & Medicaid
and CMS document identifier, to referring for contraceptive coverage, an
Services
Paperwork@cms.hhs.gov. organization seeking to be treated as an
2. Call the Reports Clearance Office at eligible organization may self-certify (by
[Document Identifiers: CMS–10653] using EBSA Form 700), prior to the
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT: beginning of the first plan year to which
Agency Information Collection an accommodation is to apply, that it
Activities: Submission for OMB Reports Clearance Office at (410) 786–
1326. meets the definition of an eligible
Review; Comment Request organization. The eligible organization
SUPPLEMENTARY INFORMATION: Under the must provide a copy of its self-
AGENCY: Centers for Medicare & Paperwork Reduction Act of 1995 (PRA)
Medicaid Services, Department of certification to each health insurance
(44 U.S.C. 3501–3520), federal agencies issuer that would otherwise provide
Health and Human Services. must obtain approval from the Office of such coverage in connection with the
ACTION: Notice. Management and Budget (OMB) for each health plan (for insured group health
collection of information they conduct plans or student health insurance
SUMMARY: The Centers for Medicare & or sponsor. The term ‘‘collection of coverage). The issuer that receives the
Medicaid Services (CMS) is announcing information’’ is defined in 44 U.S.C. self-certification must provide separate
an opportunity for the public to 3502(3) and 5 CFR 1320.3(c) and payments for contraceptive services for
comment on CMS’ intention to collect includes agency requests or plan participants and beneficiaries (or
information from the public. Under the requirements that members of the public students and dependents). For a self-
Paperwork Reduction Act of 1995 submit reports, keep records, or provide insured group health plan, the self-
(PRA), federal agencies are required to information to a third party. Section certification must be provided to its
publish notice in the Federal Register 3506(c)(2)(A) of the PRA (44 U.S.C. third party administrator. An eligible
concerning each proposed collection of 3506(c)(2)(A)) requires federal agencies organization may alternatively submit a
information, including each proposed to publish a 30-day notice in the notification to HHS as an alternative to
extension or reinstatement of an existing Federal Register concerning each submitting the EBSA Form 700 to the
collection of information, and to allow proposed collection of information, eligible organization’s health insurance
a second opportunity for public including each proposed extension or issuer or third party administrator. A
comment on the notice. Interested reinstatement of an existing collection health insurance issuer or third party
persons are invited to send comments of information, before submitting the administrator providing or arranging
regarding the burden estimate or any collection to OMB for approval. To payments for contraceptive services for
other aspect of this collection of comply with this requirement, CMS is participants and beneficiaries in plans
information, including the necessity and publishing this notice that summarizes (or student enrollees and covered
utility of the proposed information the following proposed collection(s) of dependents in student health insurance
collection for the proper performance of information for public comment: coverage) of eligible organizations must
the agency’s functions, the accuracy of 1. Type of Information Collection
sradovich on DSK3GMQ082PROD with NOTICES
provide a written notice to such plan
the estimated burden, ways to enhance Request: Revision of a currently participants and beneficiaries (or such
the quality, utility, and clarity of the approved collection; Title of student enrollees and covered
information to be collected, and the use Information Collection: Coverage of dependents) informing them of the
of automated collection techniques or Certain Preventive Services Under the availability of such payments.
other forms of information technology to Affordable Care Act; Use: The 2017 Under the interim final regulations,
minimize the information collection interim final regulations titled eligible organizations can revoke at any
burden. ‘‘Religious Exemptions and time the accommodation process if
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![17556 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
participants and beneficiaries receive DEPARTMENT OF HEALTH AND information, or other information that
written notice of such revocation from HUMAN SERVICES identifies you in the body of your
the issuer or third party administrator in comments, that information will be
accordance with guidance issued by the Food and Drug Administration posted on https://www.regulations.gov.
Secretary, and if the accommodation [Docket No. FDA–2018–D–1176]
• If you want to submit a comment
process is currently being utilized, such with confidential information that you
revocation will be effective on the first Q7 Good Manufacturing Practice do not wish to be made available to the
day of the first plan year that begins on Guidance for Active Pharmaceutical public, submit the comment as a
Ingredients: Questions and Answers; written/paper submission and in the
or after thirty days after the date of
International Council for manner detailed (see ‘‘Written/Paper
revocation.
Harmonisation; Guidance for Industry; Submissions’’ and ‘‘Instructions’’).
Final rules were published in the Availability
Federal Register on July 14, 2015 (80 FR Written/Paper Submissions
41318) under which qualifying closely AGENCY: Food and Drug Administration, Submit written/paper submissions as
held, for-profit entities may avail HHS. follows:
themselves of the accommodation to ACTION: Notice of availability. • Mail/Hand Delivery/Courier (for
effectively exempt their plans from the written/paper submissions): Dockets
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
otherwise applicable requirement to Administration (FDA or Agency) is Drug Administration, 5630 Fishers
cover certain contraceptive services. announcing the availability of a final Lane, Rm. 1061, Rockville, MD 20852.
Previously, this accommodation had guidance for industry entitled ‘‘Q7 Good • For written/paper comments
been available only to non-profit eligible Manufacturing Practice Guidance for submitted to the Dockets Management
organizations. These final rules also Active Pharmaceutical Ingredients: Staff, FDA will post your comment, as
finalized the 2014 interim final rules Questions and Answers.’’ The guidance well as any attachments, except for
permit an eligible organization to notify was prepared under the auspices of the information submitted, marked and
HHS directly that it will not contract, International Council for Harmonisation identified, as confidential, if submitted
arrange, pay, or refer for all or a subset (ICH), formerly the International as detailed in ‘‘Instructions.’’
of contraceptive services. Conference on Harmonisation. This Instructions: All submissions received
Due to judicial decisions question and answer (Q&A) guidance must include the Docket No. FDA–
preliminarily enjoining the addresses questions about 2018–D–1176 for ‘‘Q7 Good
implementation of the 2017 interim implementation of FDA’s guidance ‘‘Q7 Manufacturing Practice Guidance for
Good Manufacturing Practice Guidance Active Pharmaceutical Ingredients:
final regulations, the information
for Active Pharmaceutical Ingredients’’ Questions and Answers; International
collection requirements are drafted to be
(ICH Q7). The Q&A guidance is Council for Harmonisation; Guidance
applicable under whichever intended to clarify uncertainties due to for Industry; Availability.’’ Received
accommodation rules are in effect (for the interpretation of certain sections of comments will be placed in the docket
example, the 2017 interim final rules, or ICH Q7 and to help ensure that all and, except for those submitted as
the 2015 final rules if the 2017 interim active pharmaceutical ingredients (APIs) ‘‘Confidential Submissions,’’ publicly
final rules continue to be enjoined). meet the standards for quality and viewable at https://www.regulations.gov
HHS will only implement the ICRs purity they purport or are represented to or at the Dockets Management Staff
under regulations that are legally in possess. between 9 a.m. and 4 p.m., Monday
effect at the time the ICRs are used. DATES: The announcement of the through Friday.
Form Number: CMS–10653 (OMB guidance is published in the Federal • Confidential Submissions—To
control number: 0938–1344); Frequency: Register on April 20, 2018. submit a comment with confidential
On Occasion; Affected Public: Private ADDRESSES: You may submit either information that you do not wish to be
Sector; Number of Respondents: 110; electronic or written comments on made publicly available, submit your
Number of Responses: 110; Total Agency guidances at any time as comments only as a written/paper
Annual Hours: 181. (For policy follows: submission. You should submit two
questions regarding this collection, copies total. One copy will include the
contact Usree Bandyopadhyay at 410– Electronic Submissions information you claim to be confidential
786–6650.) Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
Dated: April 17, 2018. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
William N. Parham, III, https://www.regulations.gov. Follow the Agency will review this copy, including
Director, Paperwork Reduction Staff, Office instructions for submitting comments. the claimed confidential information, in
of Strategic Operations and Regulatory Comments submitted electronically, its consideration of comments. The
Affairs. including attachments, to https:// second copy, which will have the
[FR Doc. 2018–08329 Filed 4–19–18; 8:45 am] www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4120–01–P the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
sradovich on DSK3GMQ082PROD with NOTICES
confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
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Document Created: 2018-04-20 00:02:39
Document Modified: 2018-04-20 00:02:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by May 21, 2018. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 83 FR 17555 |
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