80_FR_9767 80 FR 9731 - Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry; Availability

80 FR 9731 - Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 36 (February 24, 2015)

Page Range9731-9732
FR Document2015-03694

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #229) entitled ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle.''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.

Federal Register, Volume 80 Issue 36 (Tuesday, February 24, 2015) 
[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9731-9732]
From the Federal Register Online  [www.thefederalregister.org]
[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Cattle; Draft Guidance for Industry; Availability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.

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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availability of a draft guidance for industry (GFI #229) entitled 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 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, [email protected].

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 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: 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

Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 9731 to publish a 30-day notice in the DEPARTMENT OF HEALTH AND Toxin-Producing E. coli in Cattle.’’ The Federal Register concerning each HUMAN SERVICES purpose of this document is to provide proposed collection of information, recommendations to industry relating to including each proposed extension or Administration for Children and study design and describe criteria the reinstatement of an existing collection Families Center for Veterinary Medicine (CVM) of information, before submitting the thinks are the most appropriate for the [OMB No.: 0970–0139] collection to OMB for approval. To evaluation of the effectiveness of new comply with this requirement, CMS is Uniform Project Description (UPD) animal drugs that are intended to reduce publishing this notice that summarizes Project Narrative Format for pathogenic Shiga toxin-producing E. the following proposed collection(s) of Discretionary Grant Application coli (STEC) in cattle. information for public comment: Forms; Correction DATES: Although you can comment on 1. Type of Information Collection any guidance at any time (see 21 CFR AGENCY: Administration for Children 10.115(g)(5)), to ensure that the Agency Request: Extension of a currently and Families, HHS. considers your comment on this draft approved collection; Title of ACTION: Notice; correction. guidance before it begins work on the Information Collection: Summary of final version of the guidance, submit Benefits and Coverage and Uniform SUMMARY: The Administration for either electronic or written comments Glossary; Use: Section 2715 of the PHS Children and Families published a on the draft guidance by April 27, 2015. Act directs the Department of Health document in the Federal Register of February 17, 2015, concerning a request ADDRESSES: Submit written requests for and Human Services (HHS), the for comments on a proposed single copies of the guidance to the Department of Labor (DOL), and the information collection. The document Communications Staff (HFV–12), Center Department of the Treasury contained an incorrect citation. for Veterinary Medicine, Food and Drug (collectively, the Departments), in FOR FURTHER INFORMATION CONTACT: Administration, 7519 Standish Pl., consultation with the National Rockville, MD 20855. Send one self- Association of Insurance Commissioners Christopher Beach, Senior Grants Policy Specialist, Division of Grants Policy, addressed adhesive label to assist that (NAIC) and a working group comprised office in processing your requests. See of stakeholders, to ‘‘develop standards Office of Administration, Administration for Children and the SUPPLEMENTARY INFORMATION section for use by a group health plan and a for electronic access to the draft health insurance issuer in compiling Families, telephone (202) 401–1539. Correction: In the Federal Register of guidance document. and providing to applicants, enrollees, Submit electronic comments on the February 17, 2015, in FR. Doc. 2015– and policyholders and certificate draft guidance to http:// 03144, on page 8324, in the third holders a summary of benefits and www.regulations.gov. Submit written column, correct the last sentence of the coverage explanation that accurately ‘‘Description’’ caption to read: comments to the Division of Dockets describes the benefits and coverage ‘‘Guidance for the content of Management (HFA–305), Food and Drug under the applicable plan or coverage.’’ information requested in the Uniform Administration, 5630 Fishers Lane, Rm. To implement these disclosure Project Description is based in 45 CFR 1061, Rockville, MD 20852. requirements, collection of information 75.203 and Appendix I to 45 CFR part FOR FURTHER INFORMATION CONTACT: requests relate to the provision of the 75.’’ Joshua R. Hayes, Center for Veterinary following: Summary of benefits and Medicine (HFV–133), Food and Drug coverage, which includes coverage Christopher Beach, Administration, 7500 Standish Pl., examples; a uniform glossary of health Senior Grants Policy Specialist, Office of Rockville, MD 20855, 240–402–0651, Administration. coverage and medical terms; and a Joshua.hayes@fda.hhs.gov. [FR Doc. 2015–03627 Filed 2–23–15; 8:45 am] notice of modifications. Form Number: SUPPLEMENTARY INFORMATION: CMS–10407 (OMB control number BILLING CODE 4184–01–P 0938–1146); Frequency: Annual; I. Background Affected Public: Private Sector— FDA is announcing the availability of DEPARTMENT OF HEALTH AND Business or other for-profits and Not- HUMAN SERVICES a draft guidance for industry (GFI #229) for-profit institutions; Number of entitled ‘‘Evaluating the Effectiveness of Respondents: 126,500; Number of Food and Drug Administration New Animal Drugs for the Reduction of Responses: 41,153,858; Total Annual Pathogenic Shiga Toxin-Producing E. Hours: 322,411. (For policy questions [Docket No. FDA–2015–D–0235] coli in Cattle.’’ This draft guidance regarding this collection, contact provides recommendations to industry Evaluating the Effectiveness of New Heather Raeburn at 301–492–4224.) relating to study design and describes Animal Drugs for the Reduction of criteria CVM thinks are the most Dated: February 18, 2015. Pathogenic Shiga Toxin-Producing appropriate for the evaluation of the William N. Parham, III, Escherichia coli in Cattle; Draft effectiveness of new animal drugs that Director, Paperwork Reduction Staff, Office Guidance for Industry; Availability are intended to reduce pathogenic STEC of Strategic Operations and Regulatory AGENCY: Food and Drug Administration, in cattle. It discusses general Affairs. HHS. considerations regarding the [FR Doc. 2015–03650 Filed 2–23–15; 8:45 am] development of protocols, study ACTION: Notice. tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4120–01–P conduct, animal welfare, substantial SUMMARY: The Food and Drug evidence of effectiveness, experimental Administration (FDA) is announcing the parameters, nutritional content of availability of a draft guidance for experimental diets, and the assessment industry (GFI #229) entitled ‘‘Evaluating of drug concentrations in experimental the Effectiveness of New Animal Drugs diets. It also discusses the studies and for the Reduction of Pathogenic Shiga analyses CVM recommends for sponsors VerDate Sep<11>2014 17:31 Feb 23, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\24FEN1.SGM 24FEN1

9732 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices to substantiate the effectiveness of DEPARTMENT OF HEALTH AND updated fish advice, entitled ‘‘Fish: pathogenic STEC reduction drugs. HUMAN SERVICES What Pregnant Women and Parents Should Know,’’ for public comment (the II. Significance of Guidance Food and Drug Administration notice). The draft advice is available This level 1 draft guidance is being [Docket No. FDA–2014–N–0595] electronically at http://www.fda.gov/ issued consistent with FDA’s good Food/FoodborneIllnessContaminants/ guidance practices regulation (21 CFR Environmental Protection Agency and Metals/ucm393070.htm. The notice 10.115). The draft guidance, when Food and Drug Administration Advice stated that the comment period would finalized, will represent the Agency’s About Eating Fish; Closure of the be open until 30 days after the last current thinking on this topic. It does Public Comment Period transcript became available from either not create or confer any rights for or on AGENCY: Food and Drug Administration, the FDA Risk Communication Advisory any person and does not operate to bind HHS. Committee (RCAC) meeting to be held FDA or the public. An alternative Notice; closure of the public ACTION: on the draft advice or any other public approach may be used if such approach comment period. meeting that the Agencies chose to hold satisfies the requirements of the on the draft advice (79 FR 33559). The applicable statutes and regulations. SUMMARY: On June 11, 2014, the Food notice also stated that the date for and Drug Administration (FDA), in closure of public comment will be III. Paperwork Reduction Act of 1995 coordination with the U.S. published in a future notice in the Environmental Protection Agency Federal Register (id.). This draft guidance refers to (EPA), (the Agencies), released for previously approved collections of The RCAC meeting was held on public comment draft fish consumption information found in FDA regulations. November 3 and 4, 2014, and the advice entitled ‘‘Fish: What Pregnant These collections of information are Women and Parents Should Know.’’ transcript of the meeting became subject to review by the Office of The draft advice would update the available on December 2, 2014. The Management and Budget (OMB) under Agencies’ consumption advice and meeting addressed the draft updated the Paperwork Reduction Act of 1995 recommend that women who are fish advice in great detail and included (44 U.S.C. 3501–3520). The collections pregnant (or might become pregnant) or presentations by the Agencies on both of information in 21 CFR part 514 have nursing and anyone who prepares food the substance and the presentation of been approved under OMB control for young children eat certain amounts the draft advice, and included number 0910–0032. and types of fish in order to improve presentations by invited experts in risk health and developmental outcomes communications. The meeting also IV. Comments provided members of the public with an while minimizing risk from Interested persons may submit either methylmercury in fish. The draft advice opportunity to express their views to the electronic comments regarding this is consistent with recommendations in RCAC and to members of the Agencies document to http://www.regulations.gov the Dietary Guidelines for Americans who were in attendance. A number of or written comments to the Division of 2010, which are issued every 5 years by organizations and private citizens Dockets Management (see ADDRESSES). It the U.S. Departments of Agriculture and availed themselves of this opportunity. is only necessary to send one set of Health and Human Services. FDA and For these reasons, FDA and EPA have EPA are now announcing the closure of concluded that the thoroughness of this comments. Identify comments with the the public comment period. public meeting, in addition to the public docket number found in brackets in the DATES: The comment period will close comments received and still to be heading of this document. Received comments may be seen in the Division on March 26, 2015. received, remove the need for additional of Dockets Management between 9 a.m. ADDRESSES: Comments may continue to public meetings and are hereby closing and 4 p.m., Monday through Friday, and be submitted until March 26, 2015. the public comment period on March will be posted to the docket at http:// Submit electronic comments to http:// 26, 2015. The transcript from the RCAC www.regulations.gov. www.regulations.gov. Submit written meeting is available electronically at comments to the Division of Dockets http://www.fda.gov/downloads/ V. Electronic Access Management (HFA–305), Food and Drug AdvisoryCommittees/Committees Administration, 5630 Fishers Lane, Rm. MeetingMaterials/RiskCommunication Persons with access to the Internet 1061, Rockville, MD 20852. FDA will may obtain the draft guidance at either AdvisoryCommittee/UCM425352.pdf share with EPA all comments submitted and http://www.fda.gov/downloads/ http://www.fda.gov/AnimalVeterinary/ to the FDA docket. GuidanceComplianceEnforcement/ AdvisoryCommittees/Committees FOR FURTHER INFORMATION CONTACT: MeetingMaterials/RiskCommunication GuidanceforIndustry/default.htm or FDA: William Jones, Center for Food http://www.regulations.gov. AdvisoryCommittee/UCM425353.pdf. Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Dated: February 18, 2015. Dated: February 17, 2015. Pkwy., College Park, MD 20740–3835, Leslie Kux, Leslie Kux, 240–402–1422, email: William.Jones@ Associate Commissioner for Policy. Associate Commissioner for Policy. fda.hhs.gov; EPA: Jeffrey Bigler, MS– [FR Doc. 2015–03691 Filed 2–23–15; 8:45 am] [FR Doc. 2015–03694 Filed 2–23–15; 8:45 am] 4305T, U.S. Environmental Protection BILLING CODE 4164–01–P Agency, 1200 Pennsylvania Ave. NW., tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4164–01–P 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 VerDate Sep<11>2014 17:31 Feb 23, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\24FEN1.SGM 24FEN1


Document Created: 2015-12-18 13:22:28
Document Modified: 2015-12-18 13:22:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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.
ContactJoshua R. Hayes, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0651, [email protected]
FR Citation80 FR 9731 
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