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 


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Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 13501 

TABLE 1.—Continued 

Advisory Committee and Expertise Needed to Fill Vacancies No. of 

Vacancies 

Approximate Date 

Members are Needed 

Cellular, Tissue, and Gene Therapies Advisory Committee—cellular therapies, tissue transplantation, 

gene transfer therapies and xenotransplantation including biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, 

developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics 1 March 31, 2007 

Transmissible Spongiform Encephalopathies Advisory Committee—clinical and administrative medicine, 

hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical 

sciences, consumer advocacy, sociology/ethics, and other related professions 4 As soon as possible 

3 January 31, 2008 

Vaccines and Related Biological Products Advisory Committee—immunology, molecular biology, rDNA, 

virology, bacteriology, epidemiology, biostatistics, allergy, preventive medicine, infectious diseases, 

pediatrics, microbiology, biochemistry, and other related scientific fields 3 As soon as possible 

5 January 31, 2008 

I. Functions 

A. Allergenic Products Advisory 

Committee 

The committee reviews and evaluates 

available data concerning the safety, 

effectiveness, and adequacy of labeling 

of marketed and investigational 

allergenic biological products or 

materials that are administered to 

humans for the diagnosis, prevention, or 

treatment of allergies and allergic 

diseases. 

B. Blood Products Advisory Committee 

The committee reviews and evaluates 

available data concerning the safety, 

effectiveness, and appropriate use of 

blood and products derived from blood 

and serum or biotechnology which are 

intended for use in the diagnosis, 

prevention, or treatment of human 

diseases. 

C. Cellular, Tissue and Gene Therapies 

Advisory Committee 

The committee reviews and evaluates 

available data relating to the safety, 

effectiveness, and appropriate use of 

human cells, human tissues, gene 

transfer therapies and 

xenotransplantation products which are 

intended for transplantation, 

implantation, infusion and transfer in 

the prevention and treatment of a broad 

spectrum of human diseases and in 

reconstruction, repair, or replacement of 

tissues for various conditions. 

D. Transmissible Spongiform 

Encephalopathies Advisory Committee 

The committee reviews and evaluates 

available scientific data concerning the 

safety of products which may be at risk 

for transmission of spongiform 

encephalopathies having an impact on 

the public health. 

E. Vaccines and Related Biological 

Products Advisory Committee 

The committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

which are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases. 

II. Qualifications 

Persons nominated for membership 

on the committees shall have adequately 

diversified experience appropriate to 

the work of the committee in such fields 

as clinical and administrative medicine, 

engineering, biological and physical 

sciences, statistics, and other related 

professions. The nature of specialized 

training and experience necessary to 

qualify the nominee as an expert 

suitable for appointment may include 

experience in medical practice, 

teaching, and/or research relevant to the 

field of activity of the committee. The 

particular need for vacancies on each 

committee through January 31, 2008, is 

shown in Table 1 of this document. The 

term of office is up to 4 years, 

depending on the appointment date. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified persons for 

membership on one or more of the 

advisory committees. Self-nominations 

are also accepted. Nominations shall 

include the name of the committee, a 

complete curriculum vitae of each 

nominee, current business address and 

telephone number, and shall state that 

the nominee is aware of the nomination, 

is willing to serve as a member (name 

of committee(s) must be specified), and 

appears to have no conflict of interest 

that would preclude membership. FDA 

will ask the potential candidates to 

provide detailed information concerning 

such matters as financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14 

relating to advisory committees. 

Dated: March 14, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy. 

[FR Doc. E7–5193 Filed 3–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: PulmonaryAllergy Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 1, 2007, from 8 a.m. to 5:30 

p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD. 


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