9732 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 

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This level 1 draft guidance is being 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 The draft guidance, when 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This draft guidance refers to 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may obtain the draft guidance at either 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] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0595] 

Environmental Protection Agency and 

Food and Drug Administration Advice 

About Eating Fish; Closure of the 

Public Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; closure of the public 

comment period. 

SUMMARY: 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 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. 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 

updated fish advice, entitled ‘‘Fish: 

What Pregnant Women and Parents 

Should Know,’’ for public comment (the 

notice). The draft advice is available 

electronically at http://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 

http://www.fda.gov/downloads/

AdvisoryCommittees/Committees

MeetingMaterials/RiskCommunication

AdvisoryCommittee/UCM425352.pdf 

and http://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] 

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