80_FR_9768 80 FR 9732 - Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish; Closure of the Public Comment Period

80 FR 9732 - Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish; Closure of the Public Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range9732-9732
FR Document2015-03691

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.

Federal Register, Volume 80 Issue 36 (Tuesday, February 24, 2015) 
[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Page 9732]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03691]


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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.

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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: 
[email protected]; EPA: Jeffrey Bigler, MS-4305T, U.S. 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460, 202-566-0389, email: [email protected].

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/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM425352.pdf and http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/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

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 13:23:32
Document Modified: 2015-12-18 13:23:32
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; closure of the public comment period.
DatesThe comment period will close on March 26, 2015.
ContactFDA: 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: [email protected]; EPA: Jeffrey Bigler, MS-4305T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460, 202-566-0389, email: [email protected]
FR Citation80 FR 9732 
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