Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2785 

was no use of seclusion and the only 

restraint was 2-point soft wrist restraints 

beginning in May 9, 2014. This 

reporting requirement change resulted 

in no necessary edits to the form CMS– 

10455 as soft wrist restraints may be 

used in combination with other types of 

restraints. It was estimated that this 

would reduce the volume of reports that 

must be submitted by 90 percent for 

hospitals. In addition, the final rule 

replaced the previous requirement for 

reporting via telephone to CMS, which 

proved to be cumbersome for both CMS 

and hospitals, with a requirement that 

allows submission of reports via 

telephone, facsimile or electronically, as 

determined by CMS. 

Form CMS–10455 is being revised in 

order to obtain the necessary 

information for the ROs to make a 

determination whether or not to 

authorize an on-site investigation 

related to the details surrounding the 

death of individuals associated with 

restraint and/or seclusion. Form 

Number: CMS–10455 (OMB control 

number: 0938–1210); Frequency: 

Occasionally; Affected Public: Private 

Sector; Number of Respondents: 6,389; 

Number of Responses: 6,389; Total 

Annual Hours: 2,619. (For policy 

questions regarding this collection 

contact Karina Meushaw at 410–786– 

1000.) 

Dated: January 12, 2018. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–00834 Filed 1–18–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10390] 

Agency Information Collection 

Activities: Proposed Collection; 

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 (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 

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 must be received by 

March 20, 2018. 

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 lll, 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’ website 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: 

William Parham at (410) 786–4669. 

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–10390 Hospice Quality 

Reporting Program 

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 

Type of Information Collection 

Request: Extension of a currently 

approved collection without change; 

Title of Information Collection: Hospice 

Quality Reporting Program; Use: The 

Hospice Item Set (HIS) is a 

standardized, patient-level data 

collection tool developed specifically 

for use by hospices. It is currently used 

for the collection of quality measure 

data pertaining to the Hospice Quality 

Reporting Program (HQRP). Since April 

1, 2017, hospices have been using the 

HIS V2.00.0 which specifies the 

collection of data items that support 

eight National Quality Forum (NQF) 

endorsed Quality Measures (QMs) and 

an additional measure pair for hospice. 

All Medicare-certified hospice providers 

are required to submit HIS admission 

and discharge records to CMS for each 

patient admission and discharge. The 

HIS contains data elements that are used 

by the CMS to calculate these measures 

and also allows CMS to collect quality 

data from hospices in compliance with 

Section 3004 of the Affordable Care Act. 

Form Number: CMS–10390 (OMB 

control number: 0938–1153); Frequency: 

On Occasion; Affected Public: State, 

Local, or Tribal Governments, Private 

Sector (not-for-profit institutions); 

individuals or households; Number of 

Respondents: 4,259; Total Annual 

Responses: 4,259; Total Annual Hours: 

686,630. For policy questions regarding 

this collection contact Cindy Massuda at 

(410) 786–0652. 


daltland on DSKBBV9HB2PROD with NOTICES
2786 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

Dated: January 12, 2018. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–00832 Filed 1–18–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1267] 

Compounded Drug Products That Are 

Essentially Copies of Approved Drug 

Products Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

guidance for industry entitled 

‘‘Compounded Drug Products That Are 

Essentially Copies of Approved Drug 

Products Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

For a drug product compounded by an 

outsourcing facility to qualify for the 

exemptions under section 503B of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), it must not be essentially a 

copy of one or more approved drug 

products and must meet other 

conditions in section 503B. This 

guidance sets forth FDA’s policies 

concerning the ‘‘essentially a copy’’ 

provision of section 503B of the FD&C 

Act. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 19, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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 

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 No. FDA– 

2016–D–1267 for ‘‘Compounded Drug 

Products That Are Essentially Copies of 

Approved Drug Products Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act.’’ Received comments 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 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Sara 

Rothman, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5197, Silver Spring, 

MD 20993, 301–796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Compounded Drug Products That Are 

Essentially Copies of Approved Drug 

Products Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

In 2013, the Drug Quality and Security 

Act, created new section 503B of the 

FD&C Act (21 U.S.C. 353b), which 

describes a new category of 

compounders called outsourcing 

facilities. Section 503B of the FD&C Act 

describes the conditions that must be 

satisfied for human drug products 

compounded by or under the direct 

supervision of a licensed pharmacist in 

an outsourcing facility to qualify for 

exemptions from the following three 

sections of the FD&C Act: 

• Section 502(f)(1) (21 U.S.C. 

352(f)(1)) (concerning labeling of drugs 

with adequate directions for use); 


daltland on DSKBBV9HB2PROD with NOTICES