80 FR 27971 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 80, Issue 94 (May 15, 2015)

Page Range		27971-27972
FR Document		2015-11798

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 80 Issue 94 (Friday, May 15, 2015)

[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Notices]
[Pages 27971-27972]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-437A & CMS-437B]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by July 14, 2015.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number ____, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION:

Contents

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

CMS-437A & CMS-437B State Agency Sheets for Verifying Exclusions From 
the Inpatient Prospective Payment System and Supporting Regulations

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: State Agency 
Sheets for Verifying Exclusions from the Inpatient Prospective Payment 
System and Supporting Regulations Use: For first time verification 
requests for exclusion from the Inpatient Prospective Payment System 
(IPPS), a hospital/unit must notify the Regional Office (RO) servicing 
the State in which it is located that it believes it meets the criteria 
for exclusion from the IPPS. Currently, all new inpatient 
rehabilitation facilities (IRFs) must provide written certification 
that the inpatient population it intends to serve will meet the 
requirements of the IPPS exclusion criteria for IRFs. They must also 
complete the Form CMS-437A if they are a rehabilitation unit or 
complete Form CMS-437B if they are a rehabilitation hospital. This 
information is submitted to the State Agency (SA) no later than 5 
months before the date the hospital/unit would become subject to IRF-
PPS.
    We propose to continue to use the Criteria Worksheets (Forms CMS-
437A and CMS-437B) for verifying first-time exclusions from the IPPS, 
for complaint surveys, for its annual 5 percent validation sample, and 
for facility self-attestation. These forms are related to the survey 
and certification and Medicare approval of the IPPS-excluded 
rehabilitation units and rehabilitation hospitals.
    For rehabilitation hospitals and rehabilitation units already 
excluded from the IPPS, annual onsite re-verification surveys by the SA 
are not required. These hospitals and units will be provided with a 
copy of the appropriate CMS-437 Worksheet at least 5-months prior to 
the beginning of its cost reporting period, so that the hospital/unit 
official may complete and sign an attestation statement and complete 
and return the appropriate CMS-437A or CMS-437B at least 5-months prior 
to the beginning of its cost reporting period. Fiscal Intermediaries 
will continue to verify, on an annual basis, compliance with the 60 
percent rule (42 CFR 412.29(b)(2)) for rehabilitation hospitals and 
rehabilitation units through a sample of medical records and the SA 
will verify the medical director requirement.
    The SA will maintain the documents unless instructed otherwise by 
the RO.

[[Page 27972]]

The SA will notify the RO at least 60 days prior to the end of the 
rehabilitation hospital's/unit's cost reporting period of the IRF's 
compliance or non-compliance with the payment requirements. The 
information collected on these forms, along with other information 
submitted by the IRF is necessary for determining exclusion from the 
IPPS. Hospitals and units that have already been excluded need not 
reapply for exclusion. These facilities will automatically be 
reevaluated yearly to determine whether they continue to meet the 
exclusion criteria.
    Form Number: CMS-437A and CMS-437B (OMB Control Number: 0938-0986); 
Frequency: Yearly; Affected Public: Private Sector (Business or other 
for-profits); Number of Respondents: 478; Total Annual Responses: 478; 
Total Annual Hours: 120. (For policy questions regarding this 
collection contact James Cowher at 410-786-1948).

    Dated: May 12, 2015.
William N. Parham, III
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-11798 Filed 5-14-15; 8:45 am]
 BILLING CODE 4120-01-P

27972 Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices

The SA will notify the RO at least 60 the IND review process and general submission process. Although not an
days prior to the end of the responsibilities of sponsor-investigators exhaustive step-by-step instruction
rehabilitation hospital’s/unit’s cost related to clinical investigations. Details manual, this guidance highlights certain
reporting period of the IRF’s compliance of the informational content of an IND elements of this process to facilitate a
or non-compliance with the payment as well as information needed to sponsor-investigator’s successful
requirements. The information collected complete required forms also are submission of an IND. This guidance
on these forms, along with other provided throughout this guidance. also discusses the IND review process
information submitted by the IRF is DATES: Although you can comment on and general responsibilities of sponsor-
necessary for determining exclusion any guidance at any time (see 21 CFR investigators related to clinical
from the IPPS. Hospitals and units that 10.115(g)(5)), to ensure that the Agency investigations. The guidance does not
have already been excluded need not considers your comment on this draft include discussions of all of the
reapply for exclusion. These facilities guidance before it begins work on the requirements that apply to the IND
will automatically be reevaluated yearly final version of the guidance, submit submission and review process or to
to determine whether they continue to either electronic or written comments conducting clinical research.
meet the exclusion criteria. on the draft guidance by July 14, 2015. This guidance is directed primarily at
Form Number: CMS–437A and CMS– those sponsor-investigators who are
ADDRESSES: Submit written requests for
437B (OMB Control Number: 0938– seeking to evaluate a drug that is either
single copies of the draft guidance to the
0986); Frequency: Yearly; Affected currently approved or is being
Division of Drug Information, Center for
Public: Private Sector (Business or other investigated under an existing IND for a
Drug Evaluation and Research, Food
for-profits); Number of Respondents: different indication. This guidance is
and Drug Administration, 10001 New
478; Total Annual Responses: 478; Total not intended for sponsor-investigators
Hampshire Ave., Hillandale Building,
Annual Hours: 120. (For policy who are developing a drug for
4th Floor, Silver Spring, MD 20993–
questions regarding this collection commercial purposes (i.e., seeking
0002; or the Office of Communication,
contact James Cowher at 410–786– market approval or licensure). This
Outreach, and Development (HFM–40),
1948). guidance does not apply to clinical
Center for Biologics Evaluation and
Dated: May 12, 2015. Research, Food and Drug trials that do not need to be conducted
William N. Parham, III Administration, 10903 New Hampshire under an IND (i.e., that qualify for an
Director, Paperwork Reduction Staff, Office Ave., Bldg. 71, Rm. 3128, Silver Spring, IND exemption). The guidance also is
of Strategic Operations and Regulatory MD 20993–0002. Send one self- not intended to address expanded
Affairs. addressed adhesive label to assist that access INDs or biologic devices.
[FR Doc. 2015–11798 Filed 5–14–15; 8:45 am] office in processing your requests. See This draft guidance is being issued
BILLING CODE 4120–01–P the SUPPLEMENTARY INFORMATION section consistent with FDA’s good guidance
for electronic access to the draft practices regulation (21 CFR 10.115).
guidance document. The draft guidance, when finalized, will
DEPARTMENT OF HEALTH AND Submit electronic comments on the represent the current thinking of FDA
HUMAN SERVICES draft guidance to http:// on INDs prepared and submitted by
www.regulations.gov. Submit written sponsor-investigators. It does not
Food and Drug Administration comments to the Division of Dockets establish any rights for any person and
[Docket No. FDA–2015–D–1484] Management (HFA–305), Food and Drug is not binding on FDA or the public.
Administration, 5630 Fishers Lane, Rm. You can use an alternative approach if
Investigational New Drug Applications 1061, Rockville, MD 20852. it satisfies the requirements of the
Prepared and Submitted by Sponsor- FOR FURTHER INFORMATION CONTACT: applicable statutes and regulations.
Investigators; Draft Guidance for Amalia Himaya, Center for Drug
Industry; Availability II. The Paperwork Reduction Act of
Evaluation and Research, Food and 1995
AGENCY: Food and Drug Administration, Drug Administration, 10903 New
HHS. Hampshire Ave., Bldg. 22, Rm. 6439, This guidance refers to previously
ACTION: Notice. Silver Spring, MD 20993–0002, 301– approved collections of information that
796–0700; or Stephen Ripley, Center for are subject to review by the Office of
SUMMARY: The Food and Drug Biologics Evaluation and Research, Management and Budget (OMB) under
Administration (FDA or Agency) is Food and Drug Administration, 10903 the Paperwork Reduction Act of 1995
announcing the availability of a draft New Hampshire Ave., Bldg. 71, Rm. (44 U.S.C. 3501–3520). The collections
guidance for industry entitled 7301, Silver Spring, MD 20993–0002, of information in 21 CFR part 312 have
‘‘Investigational New Drug Applications 240–402–7911. been approved under OMB control
Prepared and Submitted by Sponsor- SUPPLEMENTARY INFORMATION: number 0910–0014.
Investigators.’’ The purpose of this
I. Background III. Comments
guidance is to assist sponsor-
investigators in preparing and FDA is announcing the availability of Interested persons may submit either
submitting complete investigational a draft guidance for industry entitled electronic comments regarding this
new drug applications (INDs) to the ‘‘Investigational New Drug Applications document to http://www.regulations.gov
Center for Drug Evaluation and Research Prepared and Submitted by Sponsor- or written comments to the Division of
mstockstill on DSK4VPTVN1PROD with NOTICES

(CDER) and the Center for Biologics Investigators.’’ The purpose of this Dockets Management (see ADDRESSES). It
Evaluation and Research (CBER) at FDA. guidance is to assist investigators in is only necessary to send one set of
Although not an exhaustive step-by-step preparing and submitting complete comments. Identify comments with the
instruction manual, this guidance INDs to CDER and CBER at FDA. docket number found in brackets in the
highlights certain elements of this Sponsor-investigators seeking to do heading of this document. Received
process to facilitate a sponsor- clinical research often do not have the comments may be seen in the Division
investigator’s successful submission of regulatory knowledge or the resources to of Dockets Management between 9 a.m.
an IND. This guidance also discusses hire experts to help them with the IND and 4 p.m., Monday through Friday, and

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Document Created: 2018-02-21 10:27:26
Document Modified: 2018-02-21 10:27:26

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 must be received by July 14, 2015.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		80 FR 27971

80 FR 27971 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 94 (May 15, 2015)

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