Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices 27971 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat Division, 1800 F 

Street NW., Washington, DC 20405, 

telephone 202–501–4755. 

Please cite OMB Control No. 3090– 

0205, Environmental Conservation, 

Occupational Safety, and Drug-Free 

Workplace, in all correspondence. 

Dated: May 12, 2015. 

Jeffrey A Koses, 

Director, Office of Acquisition Policy, Senior 

Procurement Executive. 

[FR Doc. 2015–11749 Filed 5–14–15; 8:45 am] 

BILLING CODE 6820–61–P 

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. 

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 

Paperwork@cms.hhs.gov. 

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 selfattestation. 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 reverification 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

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

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–1484] 

Investigational New Drug Applications 

Prepared and Submitted by SponsorInvestigators; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Investigational New Drug Applications 

Prepared and Submitted by SponsorInvestigators.’’ The purpose of this 

guidance is to assist sponsorinvestigators in preparing and 

submitting complete investigational 

new drug applications (INDs) to the 

Center for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) at FDA. 

Although not an exhaustive step-by-step 

instruction manual, this guidance 

highlights certain elements of this 

process to facilitate a sponsorinvestigator’s successful submission of 

an IND. This guidance also discusses 

the IND review process and general 

responsibilities of sponsor-investigators 

related to clinical investigations. Details 

of the informational content of an IND 

as well as information needed to 

complete required forms also are 

provided throughout this guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by July 14, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach, and Development (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 3128, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Amalia Himaya, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6439, 

Silver Spring, MD 20993–0002, 301– 

796–0700; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Investigational New Drug Applications 

Prepared and Submitted by SponsorInvestigators.’’ The purpose of this 

guidance is to assist investigators in 

preparing and submitting complete 

INDs to CDER and CBER at FDA. 

Sponsor-investigators seeking to do 

clinical research often do not have the 

regulatory knowledge or the resources to 

hire experts to help them with the IND 

submission process. Although not an 

exhaustive step-by-step instruction 

manual, this guidance highlights certain 

elements of this process to facilitate a 

sponsor-investigator’s successful 

submission of an IND. This guidance 

also discusses the IND review process 

and general responsibilities of sponsorinvestigators related to clinical 

investigations. The guidance does not 

include discussions of all of the 

requirements that apply to the IND 

submission and review process or to 

conducting clinical research. 

This guidance is directed primarily at 

those sponsor-investigators who are 

seeking to evaluate a drug that is either 

currently approved or is being 

investigated under an existing IND for a 

different indication. This guidance is 

not intended for sponsor-investigators 

who are developing a drug for 

commercial purposes (i.e., seeking 

market approval or licensure). This 

guidance does not apply to clinical 

trials that do not need to be conducted 

under an IND (i.e., that qualify for an 

IND exemption). The guidance also is 

not intended to address expanded 

access INDs or biologic devices. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on INDs prepared and submitted by 

sponsor-investigators. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

mstockstill on DSK4VPTVN1PROD with NOTICES