Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 13499 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

200 30 6,000 .5 3,000 

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

FDA projects 30 emergency risk 

related surveys per year with a sample 

of between 50 and 200 respondents per 

survey. FDA also projects a response 

time of 0.5 hours per response. These 

estimates are based on the maximum 

sample size per questionnaire that FDA 

can analyze in a timely manner. The 

annual frequency of response was 

determined by the maximum number of 

questionnaires that will be sent to any 

individual respondent. Some 

respondents may be contacted only one 

time per year, while other respondents 

may be contacted several times 

annually, depending on the human 

drug, biologic, or medical device under 

evaluation. It is estimated that, given the 

expected type of issues that will be 

addressed by the surveys, it will take 0.5 

hours for a respondent to gather the 

requested information and fill in the 

answers. 

Dated: March 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5195 Filed 3–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0527] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 23, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Threshold of Regulation for Substances 

Used in Food-Contact Articles (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 

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. 

In the Federal Register of January 8, 

2007 (72 FR 792), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


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13500 Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 

TABLE 1. —ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual 

Frequencyper 

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 Web site 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: March 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5196 Filed 3–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Request for Nominations for Voting 

Members on Public Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Allergenic Products 

Advisory Committee, Blood Products 

Advisory Committee, Cellular, Tissue 

and Gene Therapies Advisory 

Committee, Transmissible Spongiform 

Encephalopathies Advisory Committee, 

and the Vaccines and Related Biological 

Products Advisory Committee in the 

Center for Biologics Evaluation and 

Research (CBER). Nominations will be 

accepted for vacancies that will or may 

occur through January 31, 2008. 

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: Because scheduled vacancies 

occur on various dates throughout each 

year, no cutoff date is established for the 

receipt of nominations. However, when 

possible, nominations should be 

received 6 months before the date of 

scheduled vacancies for each year, as 

indicated in this notice. 

ADDRESSES: All nominations and 

curricula vitae should be sent to the 

contact person listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Donald Jehn, Division of Scientific 

Advisors and Consultants, Center for 

Biologics Evaluation and Research 

(HFM–71), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448, 301–827–

0314, e-mail: donald.jehn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations of voting 

members with appropriate expertise for 

vacancies listed below: 

TABLE 1. 

Advisory Committee and Expertise Needed to Fill Vacancies No. of 

Vacancies 

Approximate Date 

Members are Needed 

Allergenic Products Advisory Committee—allergy, immunology, pediatrics, internal medicine, biochemistry, statistics, and related scientific fields 2 As soon as possible 

2 August 31, 2007 

Blood Products Advisory Committee—clinical and administrative medicine, hematology, immunology, 

blood banking, surgery, internal medicine, biochemistry, engineering, statistics, biological and physical sciences, biotechnology, computer technology, epidemiology, consumer advocacy, sociology/ethics, clinical trials, behavioral science, risk communication and other related professions 2 September 30, 2007 


rwilkins on PROD1PC63 with NOTICES