82 FR 56243 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 227 (November 28, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 227 (November 28, 2017)
| Page Range | 56243-56244 | |
| FR Document | 2017-25612 |
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)] [Notices] [Pages 56243-56244] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25612] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-R-185, CMS-437 and CMS-10515] Agency Information Collection Activities: Submission for OMB Review; 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 (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 December 28, 2017. 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' Web site address at Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669. 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: Extension of currently approved collection; Title of Information Collection: Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs; Use: The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). If an accreditation organization is approved, the laboratories that it accredits are ``deemed'' to meet the CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements. The information collected will be used by HHS to: Determine comparability/equivalency of the accreditation organization standards and policies or State licensure program standards and policies to those of the CLIA program; to ensure the continued comparability/equivalency of the standards; and to fulfill certain statutory reporting requirements. Form Number: CMS-R- 185 (OMB control number: 0938-0686); Frequency: Occasionally; Affected Public: Private Sector--Business or other for-profits and Not-for- profit institutions; Number of Respondents: 9; Total Annual Responses: 9; Total Annual Hours: 5,464. (For policy questions regarding this collection contact Arlene Lopez at 410-786-6782.) 2. Type of Information Collection Request: Reinstatement with Change of a previously approved collection; Title of Information Collection: Psychiatric Unit Criteria Work Sheet; Use: Certain specialty hospitals and hospital specialty distinct-part units may be excluded from the Inpatient Medicare Prospective Payment System (IPPS) and be paid at a different rate. These specialty hospitals and distinct-part units of hospitals include Inpatient Rehabilitation Facilities (IRFs) units, Inpatient Rehabilitation Facilities (IRFs) hospitals and Inpatient Psychiatric Facilities (IPFs). CMS regulations at 42 CFR 412.20 through 412.29 describe the criteria under which these specialty hospitals and specialty distinct- part hospital units are excluded from the IPPS. Form CMS-437 is used by Inpatient Psychiatric Facilities (IPFs) to attest to meeting the necessary requirements that make them exempt for receiving payment from Medicare under the IPPS. These IPFs must use CMS-437 to attest that they meet the requirements for IPPS exempt status prior to being placed into excluded status. The IPFs must re-attest to meeting the exclusion criteria annually. Form Number: CMS-437 (OMB control number: 0938- 0358); Frequency: Annually; Affected Public: Private sector--Business or other for-profits; Number of Respondents: 1,616; Total Annual Responses: 1,616; Total Annual Hours: 1,212. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Payment Collections Operations Contingency [[Page 56244]] Plan; Use: Under sections 1401, 1411, and 1412 of the Affordable Care Act and 45 CFR part 155 subpart D, an Exchange makes an advance determination of tax credit eligibility for individuals who enroll in QHP coverage through the Exchange and seek financial assistance. Using information available at the time of enrollment, the Exchange determines whether the individual meets the income and other requirements for advance payments and the amount of the advance payments that can be used to pay premiums. Advance payments are made periodically under section 1412 of the Affordable Care Act to the issuer of the QHP in which the individual enrolls. Section 1402 of the Affordable Care Act provides for the reduction of cost sharing for certain individuals enrolled in a QHP through an Exchange, and section 1412 of the Affordable Care Act provides for the advance payment of these reductions to issuers. The statute directs issuers to reduce cost sharing for essential health benefits for individuals with household incomes between 100 and 400 percent of the Federal poverty level (FPL) who are enrolled in a silver level QHP through an individual market Exchange and are eligible for advance payments of the premium tax credit. The data collection will be used by HHS to make payments or collect charges from issuers under the following programs: advance payments of the premium tax credit, advanced cost-sharing reductions, and Marketplace user fees. The template will be used to make payments in January 2014 and for a number of months thereafter, as may be required based on HHS's operational progress. Form Number: CMS-10515 (OMB control number: 0938-1217); Frequency: Monthly; Affected Public: Private sector (Business or other for-profits and not-for-profit institutions); Number of Respondents: 575; Total Annual Responses: 7,475; Total Annual Hours: 51,175. (For policy questions regarding this collection contact Jaya Ghildiyal at 301-492-5149). Dated: November 21, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-25612 Filed 11-27-17; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 56243
Dated: November 21, 2017. To obtain copies of a supporting stringent than those of CLIA, its
William N. Parham, III, statement and any related forms for the laboratories are considered to be exempt
Director, Paperwork Reduction Staff, Office proposed collection(s) summarized in from CLIA certification and
of Strategic Operations and Regulatory this notice, you may make your request requirements. The information collected
Affairs. using one of following: will be used by HHS to: Determine
[FR Doc. 2017–25621 Filed 11–27–17; 8:45 am] 1. Access CMS’ Web site address at comparability/equivalency of the
BILLING CODE 4120–01–P Web site address at https:// accreditation organization standards
www.cms.gov/Regulations-and- and policies or State licensure program
Guidance/Legislation/ standards and policies to those of the
DEPARTMENT OF HEALTH AND PaperworkReductionActof1995/PRA- CLIA program; to ensure the continued
HUMAN SERVICES Listing.html. comparability/equivalency of the
2. Email your request, including your standards; and to fulfill certain statutory
Centers for Medicare & Medicaid address, phone number, OMB number, reporting requirements. Form Number:
Services and CMS document identifier, to CMS–R–185 (OMB control number:
Paperwork@cms.hhs.gov. 0938–0686); Frequency: Occasionally;
[Document Identifiers: CMS–R–185, CMS–
437 and CMS–10515] 3. Call the Reports Clearance Office at Affected Public: Private Sector—
(410) 786–1326. Business or other for-profits and Not-
Agency Information Collection FOR FURTHER INFORMATION CONTACT: for-profit institutions; Number of
Activities: Submission for OMB William Parham at (410) 786–4669. Respondents: 9; Total Annual
Review; Comment Request SUPPLEMENTARY INFORMATION: Under the
Responses: 9; Total Annual Hours:
Paperwork Reduction Act of 1995 (PRA) 5,464. (For policy questions regarding
AGENCY: Centers for Medicare & this collection contact Arlene Lopez at
Medicaid Services, HHS. (44 U.S.C. 3501–3520), federal agencies
410–786–6782.)
must obtain approval from the Office of
ACTION: Notice. 2. Type of Information Collection
Management and Budget (OMB) for each
Request: Reinstatement with Change of
SUMMARY: The Centers for Medicare & collection of information they conduct a previously approved collection; Title
Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of of Information Collection: Psychiatric
an opportunity for the public to information’’ is defined in 44 U.S.C. Unit Criteria Work Sheet; Use: Certain
comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and specialty hospitals and hospital
information from the public. Under the includes agency requests or specialty distinct-part units may be
Paperwork Reduction Act of 1995 requirements that members of the public excluded from the Inpatient Medicare
(PRA), federal agencies are required to submit reports, keep records, or provide Prospective Payment System (IPPS) and
publish notice in the Federal Register information to a third party. Section be paid at a different rate. These
concerning each proposed collection of 3506(c)(2)(A) of the PRA (44 U.S.C. specialty hospitals and distinct-part
information, including each proposed 3506(c)(2)(A)) requires federal agencies units of hospitals include Inpatient
extension or reinstatement of an existing to publish a 30-day notice in the Rehabilitation Facilities (IRFs) units,
collection of information, and to allow Federal Register concerning each Inpatient Rehabilitation Facilities (IRFs)
a second opportunity for public proposed collection of information, hospitals and Inpatient Psychiatric
comment on the notice. Interested including each proposed extension or Facilities (IPFs).
persons are invited to send comments reinstatement of an existing collection CMS regulations at 42 CFR 412.20
regarding the burden estimate or any of information, before submitting the through 412.29 describe the criteria
other aspect of this collection of collection to OMB for approval. To under which these specialty hospitals
information, including the necessity and comply with this requirement, CMS is and specialty distinct-part hospital units
utility of the proposed information publishing this notice that summarizes are excluded from the IPPS. Form CMS–
collection for the proper performance of the following proposed collection(s) of 437 is used by Inpatient Psychiatric
the agency’s functions, the accuracy of information for public comment: Facilities (IPFs) to attest to meeting the
the estimated burden, ways to enhance 1. Type of Information Collection necessary requirements that make them
the quality, utility, and clarity of the Request: Extension of currently exempt for receiving payment from
information to be collected; and the use approved collection; Title of Medicare under the IPPS. These IPFs
of automated collection techniques or Information Collection: Granting and must use CMS–437 to attest that they
other forms of information technology to Withdrawal of Deeming Authority to meet the requirements for IPPS exempt
minimize the information collection Private Nonprofit Accreditation status prior to being placed into
burden. Organizations and CLIA Exemption excluded status. The IPFs must re-attest
Under State Laboratory Programs; Use: to meeting the exclusion criteria
DATES: Comments on the collection(s) of The information required is necessary to annually. Form Number: CMS–437
information must be received by the determine whether a private (OMB control number: 0938–0358);
OMB desk officer by December 28, 2017. accreditation organization/State Frequency: Annually; Affected Public:
ADDRESSES: When commenting on the licensure program standards and Private sector—Business or other for-
proposed information collections, accreditation/licensure process is at profits; Number of Respondents: 1,616;
please reference the document identifier least equal to or more stringent than Total Annual Responses: 1,616; Total
or OMB control number. To be assured those of the Clinical Laboratory Annual Hours: 1,212. (For policy
consideration, comments and Improvement Amendments of 1988 questions regarding this collection
ethrower on DSK3G9T082PROD with NOTICES
recommendations must be received by (CLIA). If an accreditation organization contact Caroline Gallaher at 410–786–
the OMB desk officer via one of the is approved, the laboratories that it 8705.)
following transmissions: OMB, Office of accredits are ‘‘deemed’’ to meet the 3. Type of Information Collection
Information and Regulatory Affairs, CLIA requirements based on this Request: Extension of a currently
Attention: CMS Desk Officer, Fax accreditation. Similarly, if a State approved collection; Title of
Number: (202) 395–5806 OR, Email: licensure program is determined to have Information Collection: Payment
OIRA_submission@omb.eop.gov. requirements that are equal to or more Collections Operations Contingency
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![56244 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
Plan; Use: Under sections 1401, 1411, DEPARTMENT OF HEALTH AND comment will be made public, you are
and 1412 of the Affordable Care Act and HUMAN SERVICES solely responsible for ensuring that your
45 CFR part 155 subpart D, an Exchange comment does not include any
makes an advance determination of tax Food and Drug Administration confidential information that you or a
credit eligibility for individuals who third party may not wish to be posted,
[Docket Nos. FDA–2016–E–0533 and FDA–
enroll in QHP coverage through the 2016–E–0534]
such as medical information, your or
Exchange and seek financial assistance. anyone else’s Social Security number, or
Using information available at the time Determination of Regulatory Review confidential business information, such
of enrollment, the Exchange determines Period for Purposes of Patent as a manufacturing process. Please note
Extension; RAPIVAB that if you include your name, contact
whether the individual meets the
information, or other information that
income and other requirements for AGENCY: Food and Drug Administration, identifies you in the body of your
advance payments and the amount of HHS. comments, that information will be
the advance payments that can be used posted on https://www.regulations.gov.
ACTION: Notice.
to pay premiums. Advance payments • If you want to submit a comment
are made periodically under section SUMMARY: The Food and Drug with confidential information that you
1412 of the Affordable Care Act to the Administration (FDA or the Agency) has do not wish to be made available to the
issuer of the QHP in which the determined the regulatory review period public, submit the comment as a
individual enrolls. Section 1402 of the for RAPIVAB and is publishing this written/paper submission and in the
Affordable Care Act provides for the notice of that determination as required manner detailed (see ‘‘Written/Paper
reduction of cost sharing for certain by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
individuals enrolled in a QHP through determination because of the
Written/Paper Submissions
an Exchange, and section 1412 of the submission of applications to the
Affordable Care Act provides for the Director of the U.S. Patent and Submit written/paper submissions as
advance payment of these reductions to Trademark Office (USPTO), Department follows:
of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
issuers. The statute directs issuers to
patent which claims that human drug written/paper submissions): Dockets
reduce cost sharing for essential health Management Staff (HFA–305), Food and
benefits for individuals with household product.
Drug Administration, 5630 Fishers
incomes between 100 and 400 percent DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
of the Federal poverty level (FPL) who of the dates as published (in the • For written/paper comments
are enrolled in a silver level QHP SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
through an individual market Exchange incorrect may submit either electronic Staff, FDA will post your comment, as
and are eligible for advance payments of or written comments and ask for a well as any attachments, except for
the premium tax credit. The data redetermination by January 29, 2018. information submitted, marked and
collection will be used by HHS to make Furthermore, any interested person may identified, as confidential, if submitted
payments or collect charges from issuers petition FDA for a determination as detailed in ‘‘Instructions.’’
under the following programs: advance regarding whether the applicant for Instructions: All submissions received
payments of the premium tax credit, extension acted with due diligence must include the Docket Nos. FDA–
advanced cost-sharing reductions, and during the regulatory review period by 2016–E–0533 and FDA–2016–E–0534
Marketplace user fees. The template will May 29, 2018. See ‘‘Petitions’’ in the for ’’Determination of Regulatory
SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
be used to make payments in January
more information. Extension; RAPIVAB.’’ Received
2014 and for a number of months
thereafter, as may be required based on ADDRESSES: You may submit comments comments, those filed in a timely
HHS’s operational progress. Form as follows. Please note that late, manner (see ADDRESSES), will be placed
untimely filed comments will not be in the docket and, except for those
Number: CMS–10515 (OMB control
considered. Electronic comments must submitted as ‘‘Confidential
number: 0938–1217); Frequency:
be submitted on or before January 29, Submissions,’’ publicly viewable at
Monthly; Affected Public: Private sector
2018. The https://www.regulations.gov https://www.regulations.gov or at the
(Business or other for-profits and not- electronic filing system will accept Dockets Management Staff between 9
for-profit institutions); Number of comments until midnight Eastern Time a.m. and 4 p.m., Monday through
Respondents: 575; Total Annual at the end of January 29, 2018. Friday.
Responses: 7,475; Total Annual Hours: Comments received by mail/hand • Confidential Submissions—To
51,175. (For policy questions regarding delivery/courier (for written/paper submit a comment with confidential
this collection contact Jaya Ghildiyal at submissions) will be considered timely information that you do not wish to be
301–492–5149). if they are postmarked or the delivery made publicly available, submit your
Dated: November 21, 2017. service acceptance receipt is on or comments only as a written/paper
William N. Parham, III, before that date. submission. You should submit two
copies total. One copy will include the
Director, Paperwork Reduction Staff, Office Electronic Submissions information you claim to be confidential
of Strategic Operations and Regulatory
Submit electronic comments in the with a heading or cover note that states
Affairs.
following way: ‘‘THIS DOCUMENT CONTAINS
ethrower on DSK3G9T082PROD with NOTICES
[FR Doc. 2017–25612 Filed 11–27–17; 8:45 am]
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4120–01–P https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
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Document Created: 2017-11-28 01:51:09
Document Modified: 2017-11-28 01:51:09
| 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 December 28, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 56243 |
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