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

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average 

burden hours 

per response 

Total burden 

hours 

RI 15-month, parent physiological component ...................................... 400 8 5 minutes or 

.08 hrs 

266.66 

RI 15-month young child physiological component ............................... 160 8 5 minutes or 

.08 hrs 

106.66 

RI 15-month, youth physiological component ....................................... 242 8 5 minutes or 

.08 hrs 

161.33 

Estimates Total Annual Burden 

Hours: 534.65 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Information Services, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for, Children and 

Families. 

Dated: January 3, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–14 Filed 1–5–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0527] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Threshold of 

Regulation for Substances Used in 

Food-Contact Articles 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requests for exemption from the food 

additive listing regulation requirements 

that are submitted under part 170 (21 

CFR part 170). 

DATES: Submit written or electronic 

comments on the collection of 

information by March 9, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Threshold of Regulation for Substances 

Used in Food-Contact Articles—21 CFR 

170.39 (OMB Control Number 0910– 

0298)—Extension 

Under section 409(a) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 348(a)), the use of a food 

additive is deemed unsafe unless one of 

the following is applicable: (1) It 

conforms to an exemption for 

investigational use under section 409(j) 

of the act, (2) it conforms to the terms 

of a regulation prescribing its use, or (3) 

in the case of a food additive which 

meets the definition of a food-contact 

substance in section 409(h)(6) of the act, 

there is either a regulation authorizing 

its use in accordance with section 

409(a)(3)(A) or an effective notification 

in accordance with section 409(a)(3)(B). 

The regulations in § 170.39 (21 CFR 

170.39) established a process that 

provides the manufacturer with an 

opportunity to demonstrate that the 

likelihood or extent of migration to food 

of a substance used in a food-contact 

article is so trivial that the use need not 

be the subject of a food additive listing 


jlentini on PROD1PC65 with NOTICES
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