14404 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: March 5, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–5674 Filed 3–8–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2002–D–0094; (formerly 

Docket No. 02D–0049)] 

Guidance for the Public, Food and 

Drug Administration (FDA) Advisory 

Committee Members, and FDA Staff: 

Public Availability of Advisory 

Committee Members’ Financial Interest 

Information and Waivers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for the public, 

FDA advisory committee members, and 

FDA staff, entitled ‘‘Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers.’’ We are issuing the 

guidance to help the public, FDA 

advisory committee members, and FDA 

staff to understand the public 

availability of information regarding 

certain financial interests and waivers 

granted by FDA to permit individuals to 

participate in an advisory committee 

meeting. The guidance provides 

additional transparency to FDA’s 

advisory committee process beyond 

current guidance. This guidance 

finalizes the draft guidance of the same 

title dated March 2010 and replaces the 

guidance of the same title dated August 

2008. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to 

Advisory Committee Oversight and 

Management Staff, Office of Special 

Medical Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5103, Silver Spring, 

MD 20993. Send one self-addressed 

adhesive label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ortwerth, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5104, Silver Spring, 

MD 20993, email: 

Michael.Ortwerth@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. The Guidance 

FDA is announcing the availability of 

a guidance entitled, ‘‘Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers.’’ FDA issues guidance 

documents for FDA staff, applicants and 

sponsors, and the public that describe 

the Agency’s current views on a subject. 

In January 2002, FDA issued draft 

guidance on ‘‘Disclosure of Conflicts of 

Interest for Special Government 

Employees Participating in FDA Product 

Specific Advisory Committees,’’ and 

requested comments on the draft 

guidance (formerly Docket No. 02D– 

0049, now Docket No. FDA–2002–D– 

0094, 67 FR 6545, February 12, 2002). 

The draft guidance was limited in 

application to special government 

employees (SGEs) participating in 

advisory committee meetings at which 

particular matters relating to particular 

products were discussed. In October 

2007, after an internal assessment of 

FDA’s advisory committee process, FDA 

published a revised draft guidance for 

public comment (72 FR 61657, October 

31, 2007). The Agency reviewed the 

submitted comments on the January 

2002 draft guidance, the October 2007 

draft guidance, and the results of the 

internal assessment of FDA’s advisory 

committee process and issued guidance 

that expanded public availability of 

relevant information to include regular 

Government employees and SGEs, 

brought additional transparency to 

FDA’s waiver process, and increased the 

consistency and clarity of the process 

(73 FR 45459, August 5, 2008) 

(www.fda.gov/downloads/ 

RegulatoryInformation/Guidances/ 

ucm125647.pdf). 

In the Federal Register of April 22, 

2010 (75 FR 21000), FDA issued for 

public comment ‘‘Draft Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers,’’ dated March 2010. The 

Agency explained that it tentatively 

concluded it is appropriate for 

additional information to be disclosed 

for individuals receiving a waiver of 

conflict of interest prior to participating 

in an FDA advisory committee meeting. 

Specifically, FDA proposed disclosure 

of the name of the company or 

institution associated with the financial 

interest. The Agency based its draft 

guidance on the expectation that: (1) 

This information would help the public 

understand the nature of the potential 

conflict and FDA’s decision-making and 

that (2) individuals invited as advisory 

committee members would agree to the 

inclusion of this level of detail as a 

routine part of required disclosures. 

FDA specifically requested comments 

on whether disclosing the name of the 

company or institution associated with 

the financial interest would: (1) Increase 

the transparency of FDA’s decisions 

regarding advisory committee member 

participation and (2) not significantly 

deter current and potential advisory 

committee members from service on 

those committees. The draft guidance 

also included a template for disclosing 

to the public the financial interests for 

which waivers are granted, a template 

for public disclosure of waivers that 

FDA grants, and FDA’s process for 

making these documents available on its 

Web site. 

We received several comments on the 

draft guidance. No commenter indicated 

that the proposed policies would deter 

participation and most noted that it 

would increase transparency. 

FDA is issuing the draft guidance 

with minor revisions to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the public 

availability of financial interest 

information and waivers relating to the 

disclosure of conflicts of interest for 

advisory committee members 

participating in FDA advisory 

committee meetings. 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. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 14405 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

Dated: February 28, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5776 Filed 3–8–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Preparation for International 

Cooperation on Cosmetics 

Regulations; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘International 

Cooperation on Cosmetics Regulations 

(ICCR)–Preparation for ICCR–6 Meeting 

in Rockville, Maryland’’ to provide 

information and receive comments on 

the International Cooperation on 

Cosmetics Regulations (ICCR) as well as 

the upcoming meetings in Rockville, 

MD. The topics to be discussed are the 

topics for discussion at the forthcoming 

ICCR Steering Committee meeting. The 

purpose of the meeting is to solicit 

public input prior to the next steering 

committee and expert working group 

meetings in Rockville, MD on July10 to 

13, 2012. 

Date and Time: The meeting will be 

held on May 15, 2012, from 2 to 4 p.m. 

Location: The meeting will be held in 

the Washington Theater Room at the 

Hilton Washington DC/Rockville Hotel 

& Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: All participants must 

register with Kimberly Franklin, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, by 

email: Kimberly.Franklin@fda.hhs.gov 

or FAX: 301–595–7937. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including: Name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentation, to the contact 

person by May 9, 2012. 

If you need special accommodations 

due to a disability, please contact 

Kimberly Franklin (see Contact Person) 

at least 7 days in advance. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by May 9, 2012, and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 

telephone number, FAX and email of 

the proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg. Rockville, 

MD 20857. 

SUPPLEMENTARY INFORMATION: The 

purpose of the multilateral framework 

on the ICCR is to pave the way for the 

removal of regulatory obstacles to 

international trade while maintaining 

global consumer protection. 

ICCR is a voluntary international 

group of cosmetics regulatory 

authorities from the: United States, 

Japan, the European Union, and Canada. 

These regulatory authority members 

will enter into constructive dialogue 

with their relevant cosmetics’ industry 

trade associations. Currently, the ICCR 

members are: Health Canada; the 

European Directorate General for 

Enterprise and Industry; the Ministry of 

Health, Labor and Welfare of Japan; and 

the U.S. Food and Drug Administration. 

All decisions made by consensus will be 

compatible with the laws, policies, 

rules, regulations, and directives of the 

respective administrations and 

governments. Members will implement 

and/or promote actions or documents 

within their own jurisdictions and seek 

convergence of regulatory policies and 

practices. Successful implementation 

will require input from stakeholders. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by April 22, 2011, and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 

telephone number, fax, and email of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

The agenda for the public meeting 

will be made available on the Internet 

at http://www.fda.gov/Cosmetics/ 

InternationalActivities/ 

ConferencesMeetingsWorkshops/

InternationalCooperationon

CosmeticsRegulationsICCR/default.htm. 

Dated: March 6, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5744 Filed 3–8–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Ancillary Studies 

for ISC Consortium. 

Date: March 29, 2012. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Maria E. Davila-Bloom, 

Ph.D., Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 758, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 


srobinson on DSK4SPTVN1PROD with NOTICES