Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry; Availability, 9731-9732 [2015-03694]

Download as PDF Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 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. tkelley on DSK3SPTVN1PROD with NOTICES [FR Doc. 2015–03650 Filed 2–23–15; 8:45 am] 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 Administration for Children and Families, HHS. ACTION: Notice; correction. AGENCY: 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.’’ SUMMARY: 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. 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 SUMMARY: 17:31 Feb 23, 2015 Jkt 235001 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 https:// 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 BILLING CODE 4120–01–P VerDate Sep<11>2014 9731 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24FEN1.SGM 24FEN1 9732 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices to substantiate the effectiveness of pathogenic STEC reduction drugs. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Significance of Guidance Food and Drug Administration 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. [Docket No. FDA–2014–N–0595] III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 514 have been approved under OMB control number 0910–0032. IV. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: February 17, 2015. Leslie Kux, Associate Commissioner for Policy. tkelley on DSK3SPTVN1PROD with NOTICES [FR Doc. 2015–03694 Filed 2–23–15; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:31 Feb 23, 2015 Jkt 235001 Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish; Closure of the Public Comment Period AGENCY: Food and Drug Administration, HHS. Notice; closure of the public comment period. ACTION: On June 11, 2014, the Food and Drug Administration (FDA), in coordination with the U.S. Environmental Protection Agency (EPA), (the Agencies), released for public comment draft fish consumption advice entitled ‘‘Fish: What Pregnant Women and Parents Should Know.’’ The draft advice would update the Agencies’ consumption advice and recommend that women who are pregnant (or might become pregnant) or nursing and anyone who prepares food for young children eat certain amounts and types of fish in order to improve health and developmental outcomes while minimizing risk from methylmercury in fish. The draft advice is consistent with recommendations in the Dietary Guidelines for Americans 2010, which are issued every 5 years by the U.S. Departments of Agriculture and Health and Human Services. FDA and EPA are now announcing the closure of the public comment period. DATES: The comment period will close on March 26, 2015. ADDRESSES: Comments may continue to be submitted until March 26, 2015. Submit electronic comments to https:// 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. FDA will share with EPA all comments submitted to the FDA docket. FOR FURTHER INFORMATION CONTACT: FDA: William Jones, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 240–402–1422, email: William.Jones@ fda.hhs.gov; EPA: Jeffrey Bigler, MS– 4305T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460, 202–566–0389, email: bigler.jeff@epa.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of June 11, 2014 (79 FR 33559), FDA, in coordination with EPA, announced the availability of the draft SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 updated fish advice, entitled ‘‘Fish: What Pregnant Women and Parents Should Know,’’ for public comment (the notice). The draft advice is available electronically at https://www.fda.gov/ Food/FoodborneIllnessContaminants/ Metals/ucm393070.htm. The notice stated that the comment period would be open until 30 days after the last transcript became available from either the FDA Risk Communication Advisory Committee (RCAC) meeting to be held on the draft advice or any other public meeting that the Agencies chose to hold on the draft advice (79 FR 33559). The notice also stated that the date for closure of public comment will be published in a future notice in the Federal Register (id.). The RCAC meeting was held on November 3 and 4, 2014, and the transcript of the meeting became available on December 2, 2014. The meeting addressed the draft updated fish advice in great detail and included presentations by the Agencies on both the substance and the presentation of the draft advice, and included presentations by invited experts in risk communications. The meeting also provided members of the public with an opportunity to express their views to the RCAC and to members of the Agencies who were in attendance. A number of organizations and private citizens availed themselves of this opportunity. For these reasons, FDA and EPA have concluded that the thoroughness of this public meeting, in addition to the public comments received and still to be received, remove the need for additional public meetings and are hereby closing the public comment period on March 26, 2015. The transcript from the RCAC meeting is available electronically at https://www.fda.gov/downloads/ AdvisoryCommittees/Committees MeetingMaterials/RiskCommunication AdvisoryCommittee/UCM425352.pdf and https://www.fda.gov/downloads/ AdvisoryCommittees/Committees MeetingMaterials/RiskCommunication AdvisoryCommittee/UCM425353.pdf. Dated: February 18, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–03691 Filed 2–23–15; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9731-9732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03694]


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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 self-addressed 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 https://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

[[Page 9732]]

to substantiate the effectiveness of pathogenic STEC reduction drugs.

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

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 514 have been approved under 
OMB control number 0910-0032.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://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 https://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

    Dated: February 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03694 Filed 2-23-15; 8:45 am]
BILLING CODE 4164-01-P
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