10754 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

III. 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 

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/FoodGuidances or 

http://www.regulations.gov. Always 

access an FDA guidance document by 

using the Web sites listed previously to 

find the most current version of the 

guidance. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4166 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0327] 

International Conference on 

Harmonisation; Final Recommendation 

for the Revision of the Permitted Daily 

Exposure for the Solvent Cumene 

According to the Maintenance 

Procedures for the Guidance Q3C 

Impurities: Residual Solvents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final recommendation 

for the revision of the permitted daily 

exposure (PDE) for the solvent cumene 

according to the maintenance 

procedures for the guidance for industry 

entitled ‘‘Q3C Impurities: Residual 

Solvents.’’ The recommendation was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the recommendation to 

the Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The draft 

recommendation may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft 

recommendation. 

Submit electronic comments on the 

recommendation 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: 

Regarding the Q3C Guidance 

David Jacobson-Kram, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6488, 

Silver Spring, MD 20993, 301–796– 

0175. 

Regarding the ICH 

Michelle Limoli, Office of 

International Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 3506, Silver Spring, 

MD 20993–0002, 301–796–4600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory Agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In 1999, ICH instituted a Q3C 

maintenance agreement and formed a 

maintenance Expert Working Group 

(Q3C EWG). The agreement provided for 

the reconsideration of solvent PDEs and 

allowed for minor changes to the tables 

and list that include the existing PDEs. 

The agreement also provided that new 

solvents and PDEs could be added to the 

tables and list based on adequate 

toxicity data. In the Federal Register of 

February 12, 2002 (67 FR 6542), FDA 

briefly described the process for 

proposing future revisions to the PDEs. 

In the same notice, the Agency 

announced its decision to delink the 

tables and list from the Q3C guidance 

and create a stand alone document 

entitled ‘‘Q3C—Tables and List’’ to 

facilitate making changes recommended 

by ICH. 

II. Revised PDE for Cumene 

In the Federal Register of July 20, 

2010 (75 FR 42098), FDA published a 

notice announcing the availability of a 

draft recommendation for the revision of 

the PDE for cumene according to the 

ICH maintenance procedures. The 

notice gave interested persons an 

opportunity to submit comments by 

September 20, 2010. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the recommendation was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory Agencies in 

February 2011. 

The final recommendation addresses 

the safety classification of cumene. 

When the Q3C guidance was published 

in 1997 (62 FR 67377, December 24, 

1997), cumene was listed as a class 3 

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Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 10755 

solvent (i.e., a solvent with low 

toxicity). The Q3C EWG reviewed new 

toxicity data derived from a 

carcinogenicity study performed by the 

National Toxicology Program. The new 

data suggest a positive systemic 

carcinogenic effect, and this observation 

raises the toxicity associated with this 

solvent. The final recommendation is 

that cumene be placed into class 2. A 

PDE of 0.7 milligrams per day and a 

concentration limit of 70 parts per 

million are being declared for this 

solvent. The analysis and 

recommendation are available for 

review on the Internet (see section V of 

this document on electronic access). 

The final recommendation is also 

available from the Division of Drug 

Information (see ADDRESSES). The 

Agency will revise the tables in the 

guidance ‘‘Q3C—Tables and List’’ to 

reflect the ICH final recommendation for 

cumene. 

The final recommendation for the 

solvent cumene is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The revised PDE for the solvent cumene 

contained in the revised guidance 

‘‘Q3C—Tables and List’’ represents 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. 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 

docket number found in brackets in the 

heading of this document. The 

recommendation and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the Q3C guidance 

documents at http:// 

www.regulations.gov, http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/;BiologicsBlood;Vaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Information on the Q3C maintenance 

process as well as proposals, data 

analysis, and draft and final 

recommendations for revisions to the 

tables and list are available at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/ucm125820.htm. 

Dated: February 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4164 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Risk Communication 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Risk Communication Advisory 

Committee, Office of Planning, Office of 

Policy and Planning, Office of the 

Commissioner. 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Nominations received on or 

before April 23, 2012 will be given first 

consideration for membership on the 

Risk Communication Advisory 

Committee. Nominations received after 

April 23, 2012 will be considered for 

nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to cv@oc.fda.gov or by 

mail to the Advisory Committee 

Oversight and Management Staff, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5103, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, the primary contact is: Lee 

L. Zwanziger, Risk Communication 

Staff, Office of Planning, Office of Policy 

and Planning, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–9151, Fax: 301–847–8611, 

RCAC@FDA.HHS.GOV. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site by using the following link: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members on the Risk Communication 

Advisory Committee. 

I. General Description of the Committee 

Duties 

The Risk Communication Advisory 

Committee advises the Commissioner of 

Food and Drugs or designee on methods 

to effectively communicate risks 

associated with products regulated by 

the Food and Drug Administration and 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and any 

other product for which the Food and 

Drug Administration has regulatory 

responsibility. 

The Committee reviews and evaluates 

strategies and programs designed to 

communicate with the public about the 

risks and benefits of FDA-regulated 

products so as to facilitate optimal use 

of these products. The Committee also 

reviews and evaluates research relevant 

to such communication to the public by 

both FDA and other entities. It also 

facilitates interactively sharing risk and 

benefit information with the public to 

enable people to make informed 

independent judgments about use of 

FDA-regulated products. 

II. Criteria for Voting Members 

The Committee consists of a core of 

15 voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among authorities knowledgeable in 

fields such as social marketing, health 

literacy, and other relevant areas. 

Members will include experts on risk 

communication, experts on emerging 

postmarket drug risks and individuals 

knowledgeable about and experienced 

in the work of patient, consumer, and 

health professional organizations. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. Some members will be 

selected to provide experiential insight 

on the communication needs of the 

various groups who use FDA-regulated 

products. The latter may include 

patients and patients’ family members, 

health professionals, communicators in 

health, medicine and science, and 

persons affiliated with consumer, 

specific disease, or patient safety 

advocacy groups. Members will be 

invited to serve for terms of up to 4 

years. 

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