Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 9731 

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 a currently 

approved collection; Title of 

Information Collection: Summary of 

Benefits and Coverage and Uniform 

Glossary; Use: Section 2715 of the PHS 

Act directs the Department of Health 

and Human Services (HHS), the 

Department of Labor (DOL), and the 

Department of the Treasury 

(collectively, the Departments), in 

consultation with the National 

Association of Insurance Commissioners 

(NAIC) and a working group comprised 

of stakeholders, to ‘‘develop standards 

for use by a group health plan and a 

health insurance issuer in compiling 

and providing to applicants, enrollees, 

and policyholders and certificate 

holders a summary of benefits and 

coverage explanation that accurately 

describes the benefits and coverage 

under the applicable plan or coverage.’’ 

To implement these disclosure 

requirements, collection of information 

requests relate to the provision of the 

following: Summary of benefits and 

coverage, which includes coverage 

examples; a uniform glossary of health 

coverage and medical terms; and a 

notice of modifications. Form Number: 

CMS–10407 (OMB control number 

0938–1146); Frequency: Annual; 

Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 126,500; Number of 

Responses: 41,153,858; Total Annual 

Hours: 322,411. (For policy questions 

regarding this collection, contact 

Heather Raeburn at 301–492–4224.) 

Dated: February 18, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–03650 Filed 2–23–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB No.: 0970–0139] 

Uniform Project Description (UPD) 

Project Narrative Format for 

Discretionary Grant Application 

Forms; Correction 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice; correction. 

SUMMARY: The Administration for 

Children and Families published a 

document in the Federal Register of 

February 17, 2015, concerning a request 

for comments on a proposed 

information collection. The document 

contained an incorrect citation. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Beach, Senior Grants Policy 

Specialist, Division of Grants Policy, 

Office of Administration, 

Administration for Children and 

Families, telephone (202) 401–1539. 

Correction: In the Federal Register of 

February 17, 2015, in FR. Doc. 2015– 

03144, on page 8324, in the third 

column, correct the last sentence of the 

‘‘Description’’ caption to read: 

‘‘Guidance for the content of 

information requested in the Uniform 

Project Description is based in 45 CFR 

75.203 and Appendix I to 45 CFR part 

75.’’ 

Christopher Beach, 

Senior Grants Policy Specialist, Office of 

Administration. 

[FR Doc. 2015–03627 Filed 2–23–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0235] 

Evaluating the Effectiveness of New 

Animal Drugs for the Reduction of 

Pathogenic Shiga Toxin-Producing 

Escherichia coli in Cattle; Draft 

Guidance for Industry; 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 (GFI #229) entitled ‘‘Evaluating 

the Effectiveness of New Animal Drugs 

for the Reduction of Pathogenic Shiga 

Toxin-Producing E. coli in Cattle.’’ The 

purpose of this document is to provide 

recommendations to industry relating to 

study design and describe criteria the 

Center for Veterinary Medicine (CVM) 

thinks are the most appropriate for the 

evaluation of the effectiveness of new 

animal drugs that are intended to reduce 

pathogenic Shiga toxin-producing E. 

coli (STEC) in cattle. 

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 April 27, 2015. 

ADDRESSES: Submit written requests for 

single copies of the 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: 

Joshua R. Hayes, Center for Veterinary 

Medicine (HFV–133), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0651, 

Joshua.hayes@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (GFI #229) 

entitled ‘‘Evaluating the Effectiveness of 

New Animal Drugs for the Reduction of 

Pathogenic Shiga Toxin-Producing E. 

coli in Cattle.’’ This draft guidance 

provides recommendations to industry 

relating to study design and describes 

criteria CVM thinks are the most 

appropriate for the evaluation of the 

effectiveness of new animal drugs that 

are intended to reduce pathogenic STEC 

in cattle. It discusses general 

considerations regarding the 

development of protocols, study 

conduct, animal welfare, substantial 

evidence of effectiveness, experimental 

parameters, nutritional content of 

experimental diets, and the assessment 

of drug concentrations in experimental 

diets. It also discusses the studies and 

analyses CVM recommends for sponsors 


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