15014 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1180] 

Draft Guidance for Industry on 

Ensuring Safety of Animal Feed 

Maintained and Fed On-Farm; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry #203 entitled ‘‘Ensuring Safety 

of Animal Feed Maintained and Fed OnFarm.’’ This draft guidance is intended 

to help animal producers (persons who 

feed animals) develop and implement 

on-farm practices to ensure the safety of 

animal feed maintained and fed to 

animals on the farm. 

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on the draft guidance by June 3, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. 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draft guidance to http://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: 

Phares Okelo, Center for Veterinary 

Medicine (HFV–226), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6862, 

email: phares.okelo@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry # 203 

entitled ‘‘Ensuring Safety of Animal 

Feed Maintained and Fed On-Farm.’’ 

This draft guidance is intended to help 

animal producers (persons who feed 

animals) develop and implement onfarm practices to ensure the safety of 

animal feed maintained and fed to 

animals on the farm. In this document, 

‘‘farm’’ means animal production units 

such as integrated poultry grower 

operations, swine finishing units, and 

cattle feedlots. This document outlines 

basic measures that may be taken to 

maintain the safety of all types of feed 

held on the farm for use in animal 

production. This draft guidance 

recommends establishing measures to 

ensure the acquisition of safe feed and 

maintenance of its safety until the feed 

is offered to animals in the farm 

environment. This document does not 

address feed manufacture, which also 

may occur on farms. 

II. Significance of Guidance 

This level 1 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 Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

FDA concludes that there are no 

collections of information under the 

Paperwork Reduction Act of 1995. 

IV. 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 

will be posted to the docket at http://

www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06390 Filed 3–19–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10550 and CMS– 

10551] 

Agency Information Collection 

Activities: Proposed Collection; 

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 (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 

May 19, 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 llll, Room C4–26– 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 15015 

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–10550 Hospital National 

Provider Survey 

CMS–10551 Nursing Home National 

Provider Survey 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Hospital 

National Provider Survey; Use: Section 

3104 of the Patient and Protection and 

Affordable Care Act (ACA) requires that 

the Secretary of the Department of 

Health and Human Services (HHS) 

conduct an assessment of the quality 

and efficiency impact of the use of 

endorsed measures in specific Medicare 

quality reporting and incentive 

programs. The ACA further specifies 

that the initial assessment must occur 

no later than March 1, 2012, and once 

every 3 years thereafter. This planned 

data collection activity was developed 

and tested as part of the 2015 Impact 

Report and data collection will be 

conducted for reporting in the 2018 

Impact Report. 

There are two modes of data 

collection with hospital quality leaders: 

(1) A semi-structured qualitative 

interview and (2) a standardized survey. 

The data from the qualitative interviews 

and standardized surveys will be 

analyzed to provide us with information 

on the quality and efficiency impact of 

measures that we use to assess care in 

the hospital inpatient and outpatient 

settings. The surveys seek to understand 

whether the use of performance 

measures has led to changes in provider 

behavior, and where undesired effects 

are occurring as a result of 

implementing quality and efficiency 

measures. The survey will also help 

identify characteristics associated with 

high performance, which if understood, 

could be used to leverage improvements 

in care among lower performing 

hospitals. The focus of the survey is to 

assess the impacts of the measures that 

we use in the context of public reporting 

(pay-for-reporting) and value-based 

purchasing programs. Form Number: 

CMS–10550 (OMB control number: 

0938–NEW); Frequency: Occasionally; 

Affected Public: Private Sector (Business 

or other for-profit and Not-for-profit 

institutions); Number of Respondents: 

940; Total Annual Responses: 940; Total 

Annual Hours: 639. (For policy 

questions regarding this collection 

contact Noni Bodkin at 410–786–7837.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Nursing Home 

National Provider Survey; Use: Section 

3104 of the Patient and Protection and 

Affordable Care Act (ACA) requires that 

the Secretary of the Department of 

Health and Human Services (HHS) 

conduct an assessment of the quality 

and efficiency impact of the use of 

endorsed measures in specific Medicare 

quality reporting and incentive 

programs. The ACA further specifies 

that the initial assessment must occur 

no later than March 1, 2012, and once 

every 3 years thereafter. This planned 

data collection activity was developed 

and tested as part of the 2015 Impact 

Report and data collection will be 

conducted for reporting in the 2018 

Impact Report. 

There are two modes of data 

collection with nursing home quality 

leaders: (1) A semi-structured 

qualitative interview and (2) a 

standardized survey. The data from the 

qualitative interviews and standardized 

surveys will be analyzed to provide us 

with information on the quality and 

efficiency impact of measures that we 

use to assess care in nursing homes 

delivering skilled nursing care. The 

surveys seek to understand whether the 

use of performance measures has led to 

changes in provider behavior (both at 

the nursing home-level and at the 

frontline of care), and whether 

undesired effects are occurring as a 

result of implementing quality and 

efficiency measures. The survey will 

also help identify characteristics 

associated with high performance, 

which if understood, could be used to 

leverage improvements in care among 

lower performing nursing homes. The 

focus of the survey is to assess the 

impacts of the measures that we use in 

the context of public reporting (pay-forreporting) and quality improvement. 

Form Number: CMS–10551 (OMB 

control number: 0938–NEW); 

Frequency: Occasionally; Affected 

Public: Private Sector (Business or other 

for-profit and Not-for-profit 

institutions); Number of Respondents: 

940; Total Annual Responses: 940; Total 

Annual Hours: 639. (For policy 

questions regarding this collection 

contact Noni Bodkin at 410–786–7837.) 

Dated: March 17, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–06408 Filed 3–19–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse: 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

mstockstill on DSK4VPTVN1PROD with NOTICES