Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices 793 

regulation or an effective notification. 

The agency has established two 

thresholds for the regulation of 

substances used in food-contact articles. 

The first exempts those substances used 

in food-contact articles where the 

resulting dietary concentration would 

be at or below 0.5 part per billion (ppb). 

The second exempts regulated direct 

food additives for use in food-contact 

articles where the resulting dietary 

exposure is 1 percent or less of the 

acceptable daily intake for these 

substances. 

In order to determine whether the 

intended use of a substance in a foodcontact article meets the threshold 

criteria, certain information specified in 

§ 170.39(c) must be submitted to FDA. 

This information includes the following 

components: (1) The chemical 

composition of the substance for which 

the request is made, (2) detailed 

information on the conditions of use of 

the substance, (3) a clear statement of 

the basis for the request for exemption 

from regulation as a food additive, (4) 

data that will enable FDA to estimate 

the daily dietary concentration resulting 

from the proposed use of the substance, 

(5) results of a literature search for 

toxicological data on the substance and 

its impurities, and (6) information on 

the environmental impact that would 

result from the proposed use. 

FDA uses this information to 

determine whether the food-contact 

article meets the threshold criteria. 

Respondents to this information 

collection are individual manufacturers 

and suppliers of substances used in 

food-contact articles (i.e., food 

packaging and food processing 

equipment) or of the articles themselves. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

170.39 15 1 15 48 720 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In compiling these estimates, FDA 

consulted its records of the number of 

regulation exemption requests received 

in the past 3 years. The annual hours 

per response reporting estimate is based 

on information received from 

representatives of the food packaging 

and processing industries and agency 

records. 

FDA estimates that approximately 15 

requests per year will be submitted 

under the threshold of regulation 

exemption process of § 170.39. The 

threshold of regulation process offers 

one advantage over the premarket 

notification process for food-contact 

substances established by section 409(h) 

of the act (OMB control number 0910–

0495) in that the use of a substance 

exempted by the agency is not limited 

to only the manufacturer or supplier 

who submitted the request for an 

exemption. Other manufacturers or 

suppliers may use exempted substances 

in food-contact articles as long as the 

conditions of use (e.g., use levels, 

temperature, type of food contacted, 

etc.) are those for which the exemption 

was issued. As a result, the overall 

burden on both the agency and the 

regulated industry would be 

significantly less in that other 

manufacturers and suppliers would not 

have to prepare, and FDA would not 

have to review, similar submissions for 

identical components of food-contact 

articles used under identical conditions. 

Manufacturers and other interested 

persons can easily access an up-to-date 

list of exempted substances which is on 

display at FDA’s Division of Dockets 

Management and on the Internet at 

http://www.cfsan.fda.gov. Having the 

list of exempted substances publicly 

available decreases the likelihood that a 

company would submit a food additive 

petition or a notification for the same 

type of food-contact application of a 

substance for which the agency has 

previously granted an exemption from 

the food additive listing regulation 

requirement. 

Dated: December 29, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6 Filed 1–5–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0526] 

International Conference on 

Harmonisation; Draft Guidance on E15 

Terminology in Pharmacogenomics; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘E15 Terminology in 

Pharmacogenomics.’’ The draft guidance 

was prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance contains definitions 

of key terms in the discipline of 

pharmacogenomics and 

pharmacogenetics, namely genomic 

biomarkers, pharmacogenomics, 

pharmacogenetics, and genomic data 

and sample coding categories. In the 

effort to develop harmonized 

approaches to drug regulation, it is 

important to ensure that consistent 

definitions of terminology are being 

applied across all constituents of the 

ICH. The draft guidance is intended 

facilitate the integration of the 

discipline of pharmacogenomics and 

pharmacogenetics into global drug 

development and approval processes. 

DATES: Submit written or electronic 

comments on the draft guidance by 

April 9, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857; or the Office of 

Communication, Training and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The draft 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

labels to assist the office in processing 

your requests. Submit written comments 

on the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 


jlentini on PROD1PC65 with NOTICES
794 Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Felix Frueh, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4512, 

Silver Spring, MD 20993–0002, 

301–796–1530; or 

Raj K. Puri, Center for Biologics 

Evaluation and Research (HFM–

735), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–0471. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

4480. 

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 October 2006, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘E15 Terminology in 

Pharmacogenomics’’ should be made 

available for public comment. The draft 

guidance is the product of the E15 

Pharmacogenomics Expert Working 

Group of the ICH. Comments about this 

draft will be considered by FDA and the 

E15 Pharmacogenomics Expert Working 

Group. 

The draft guidance represents an 

international effort to harmonize 

pharmacogenomics definitions and 

sample coding. Inconsistent definitions 

make it difficult to achieve agreement 

on parameters for implementation of 

pharmacogenomics in global 

pharmaceutical development, and might 

lead to inconsistent assessments by 

regulators. The draft guidance contains 

definitions of key terms in the 

discipline of pharmacogenomics and 

pharmacogenetics, namely genomic 

biomarkers, pharmacogenomics, 

pharmacogenetics, and genomic data 

and sample coding categories. Timely 

harmonisation of terminology and 

definitions will create a common 

foundation for future guidance on 

pharmacogenomics. 

This 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. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Submit 

a single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/publications.htm. 

Dated: December 29, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5 Filed 1–5–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Proposed Project: GPRA Client 

Outcomes for the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA)—(OMB No. 0930–0208)—

Revision. 

The mission of the Substance Abuse 

and Mental Health Services 

Administration (SAMHSA) is to 

improve the effectiveness and efficiency 

of substance abuse and mental health 

treatment and prevention services 

across the United States. All of 

SAMHSA’s activities are designed to 

ultimately reduce the gap in the 

availability of substance abuse and 

mental health services and to improve 

their effectiveness and efficiency. 

Data are collected from all SAMHSA 

discretionary services grants and 

contracts where client/participant 

outcomes are to be assessed at three 

points (for the Center for Substance 

Abuse Treatment (CSAT): Intake, 

discharge, and post-intake and for the 

Center for Substance Abuse Prevention 

(CSAP): pre-intervention, postintervention, and follow-up). SAMHSAfunded projects are required to submit 

these data as a contingency of their 

award. The analysis of the data also will 

help determine whether the goal of 

reducing health and social costs of drug 

use to the public is being achieved. 

The primary purpose of this data 

collection activity is to meet the 

reporting requirements of the 

Government Performance and Results 

Act (GPRA) by allowing SAMHSA to 

quantify the effects and 


jlentini on PROD1PC65 with NOTICES