Agency Information Collection Activities: Submission for OMB Review; Comment Request, 56243-56244 [2017-25612]

Download as PDF Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices Dated: November 21, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017–25621 Filed 11–27–17; 8:45 am] BILLING CODE 4120–01–P 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 Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: 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. SUMMARY: 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: OIRA_submission@omb.eop.gov. ethrower on DSK3G9T082PROD with NOTICES DATES: VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 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-andGuidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. 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: 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 56243 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 Notfor-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 forprofits; 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 E:\FR\FM\28NON1.SGM 28NON1 56244 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 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 notfor-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). ethrower on DSK3G9T082PROD with NOTICES 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 VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–E–0533 and FDA– 2016–E–0534] Determination of Regulatory Review Period for Purposes of Patent Extension; RAPIVAB AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RAPIVAB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. SUMMARY: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 29, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 29, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 29, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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 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 Nos. FDA– 2016–E–0533 and FDA–2016–E–0534 for ’’Determination of Regulatory Review Period for Purposes of Patent Extension; RAPIVAB.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56243-56244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25612]


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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: 
OIRA_submission@omb.eop.gov.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at 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 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: 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