50628 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Notices 

Terry Nicolosi, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E8–19849 Filed 8–26–08; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (DHHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold a meeting. 

The meeting is open to the public. 

DATES: The meeting will be held on 

September 16, 2008, from 9 a.m. to 5:30 

p.m., and on September 17, 2008, from 

9 a.m. to 3 p.m. 

ADDRESSES: Department of Health and 

Human Services, Hubert H. Humphrey 

Building, Room 800, 200 Independence 

Avenue, SW., Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Andrea Krull, National Vaccine Program 

Office, Department of Health and 

Human Services, Room 443–H, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201; (202) 690–5566, 

nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. Section 300aa–1), 

the Secretary of Health and Human 

Services was mandated to establish the 

National Vaccine Program to achieve 

optimal prevention of human infectious 

diseases through immunization and to 

achieve optimal prevention against 

adverse reactions to vaccines. The 

National Vaccine Advisory Committee 

was established to provide advice and 

make recommendations to the Director 

of the National Vaccine Program on 

matters related to the Program’s 

responsibilities. The Assistant Secretary 

for Health serves as Director of the 

National Vaccine Program. 

Topics to be discussed at the meeting 

include vaccine financing, vaccine 

stockpile, seasonal influenza and related 

issues, vaccine safety, vaccine 

development, and the National Vaccine 

Plan. Updates will be given by each of 

the working groups. An agenda will be 

posted on the NVAC Web site: http:// 

www.hhs.gov/nvpo/nvac prior to 

September 1, 2008. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

designated contact person. Members of 

the public will have the opportunity to 

provide comments at the meeting. 

Public comment will be limited to five 

minutes per speaker. Any members of 

the public who wish to have printed 

material distributed to NVAC members 

should submit materials to the 

Executive Secretary, NVAC, through the 

contact person listed above prior to 

close of business September 11, 2008. 

Pre-registration is required for both 

public attendance and comment. Any 

individual who wishes to attend the 

meeting and/or participate in the public 

comment session should e-mail 

nvpo@hhs.gov or call 202–690–5566. 

Dated: August 21, 2008. 

Bruce Gellin, 

Director, National Vaccine Program Office. 

[FR Doc. E8–19848 Filed 8–26–08; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

President’s Committee for People with 

Intellectual Disabilities; Notice of 

Meeting 

AGENCY: President’s Committee for 

People with Intellectual Disabilities 

(PCPID). 

ACTION: Notice of quarterly meeting. 

DATES: September 9, 2008, from 8:30 

a.m. to 5 p.m. EST; and September 10, 

2008, from 9 a.m. to 5 p.m. The meeting 

will be open to the public. 

ADDRESSES: The meeting will be held in 

Room 800 of the Hubert H. Humphrey 

Building, 200 Independence Ave., SW., 

Washington, DC 20201. Individuals who 

would like to participate via conference 

call may do so by dialing 888–603–

6970, passcode: PCPID. Individuals who 

will need accommodations for a 

disability in order to attend the meeting 

(e.g., sign language interpreting services, 

assistive listening devices, materials in 

alternative formats such as large print or 

Braille) should notify MJ Karimi via 

e-mail at 

Madjid.KarimieAsl@ACF.hhs.gov, or via 

telephone at 202–619–0634, no later 

than August 29, 2008. PCPID will 

attempt to meet requests made after that 

date, but cannot guarantee availability. 

All meeting sites are barrier free. 

Agenda: PCPID will meet to continue 

work on the 2009 Annual Report to the 

President. 

Additional Information: For further 

information, please contact Sally D. 

Atwater, Executive Director, President’s 

Committee for People with Intellectual 

Disabilities, the Aerospace Center, 

Second Floor West, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447. Telephone: 202–619–0634. Fax: 

202–205–9591. E-mail: 

satwater@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: PCPID 

acts in an advisory capacity to the 

President and the Secretary of Health 

and Human Services on a broad range 

of topics relating to programs, services 

and supports for persons with 

intellectual disabilities. PCPID, by 

Executive Order, is responsible for 

evaluating the adequacy of current 

practices in programs, services and 

supports for persons with intellectual 

disabilities, and for reviewing legislative 

proposals that impact the quality of life 

experienced by citizens with 

intellectual disabilities and their 

families. 

Dated: August 19, 2008. 

Sally D. Atwater, 

Executive Director, President’s Committee for 

People with Intellectual Disabilities. 

[FR Doc. E8–19898 Filed 8–26–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0454] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Contact 

Substances Notification System 

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 

the collection of information associated 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Notices 50629 

with the Food Contact Substances 

Notification System. 

DATES: Submit written or electronic 

comments on the collection of 

information by October 27, 2008. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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 Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Food Contact Substances Notification 

System—21 CFR 170.101, 170.106, and 

171.1 (OMB Control Number 0910–

0495)—Extension 

Section 409(h) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 348(h)) establishes a premarket 

notification process for food contact 

substances. Section 409(h)(6) of the act 

defines a ‘‘food contact substance’’ as 

‘‘any substance intended for use as a 

component of materials used in 

manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food.’’ Section 409(h)(3) of 

the act requires that the notification 

process be used for authorizing the 

marketing of food contact substances 

except when: (1) FDA determines that 

the submission and premarket review of 

a food additive petition (FAP) under 

section 409(b) of the act is necessary to 

provide adequate assurance of safety or 

(2) FDA and the manufacturer or 

supplier agree that an FAP should be 

submitted. Section 409(h)(1) of the act 

requires that a notification include: (1) 

Information on the identity and the 

intended use of the food contact 

substance and (2) the basis for the 

manufacturer’s or supplier’s 

determination that the food contact 

substance is safe under the intended 

conditions of use. 

Sections 170.101 and 170.106 of 

FDA’s regulations (21 CFR 170.101 and 

170.106) specify the information that a 

notification must contain and require 

that: (1) A food contact notification 

(FCN) include FDA Form 3480 entitled 

‘‘Notification for New Use of a Food 

Contact Substance’’ and (2) a 

notification for a food contact substance 

formulation include FDA Form 3479 

entitled ‘‘Notification for a Food Contact 

Substance Formulation.’’ These forms 

will serve to summarize pertinent 

information in the notification. FDA 

believes that these forms will facilitate 

both preparation and review of 

notifications because the forms will 

serve to organize information necessary 

to support the safety of the use of the 

food contact substance. The burden of 

filling out the appropriate form has been 

included in the burden estimate for the 

notification. 

Section 171.1 of FDA’s regulations (21 

CFR 171.1) specifies the information 

that a petitioner must submit in order 

to: (1) Establish that the proposed use of 

an indirect food additive is safe and (2) 

secure the publication of an indirect 

food additive regulation in parts 175 

through 178 (21 CFR parts 175 through 

178). Parts 175 through 178 describe the 

conditions under which the additive 

may be safely used. 

In addition, FDA’s guidance 

document entitled ‘‘Use of Recycled 

Plastics in Food Packaging: Chemistry 

Considerations’’ provides assistance to 

manufacturers of food packaging in 

evaluating processes for producing 

packaging from post-consumer recycled 

plastic. The recommendations in the 

guidance address the process by which 

manufacturers certify to FDA that their 

plastic products are safe for food 

contact. 

Description of Respondents: 

Manufacturers of food contact 

substances. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

170.1062 (Category A) FDA 3479 5 1 5 2 10 

170.1013,7 (Category B) FDA 3480 5 1 5 25 125 

170.1014,7 (Category C) FDA 3480 5 2 10 120 1,200 

170.1015,7 (Category D) FDA 3480 33 2 66 150 9,900 

170.1016,7 (Category E) FDA 3480 30 1 30 150 4,500 

171.1 Indirect Food Additive 

Petitions 

2 2 2 10,995 21,990 


sroberts on PROD1PC70 with NOTICES
50630 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Guidance 

Use of Recycled Plastics in 

Food Packaging: Chemistry 

Considerations 

10 1 10 25 250 

Total 37,975 

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

2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of FDA Form 3479 

(‘‘Notification for a Food Contact Substance Formulation’’) only. 3 Duplicate notifications for uses of food contact substances. 

4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 

5 Notifications for uses that are the subject of moderately complex food additive petitions. 

6 Notifications for uses that are the subject of very complex food additive petitions. 

7These notifications require the submission of FDA Form 3480. 

These estimates are based on FDA’s 

experience with the food contact 

substances notification system. Based 

on input from industry sources, FDA 

estimates that approximately five 

respondents will submit one 

notification annually for food contact 

substance formulations (Form FDA 

3479), for a total of five responses. FDA 

estimates the reporting burden to be 2.0 

hours per response, for a total burden of 

10 hours. FDA also has included five 

expected duplicate submissions in the 

second row of table 1 of this document. 

FDA expects that the burden for 

preparing these notifications primarily 

will consist of the manufacturer or 

supplier filling out FDA Form 3480, 

verifying that a previous notification is 

effective and preparing necessary 

documentation. Thus, FDA estimates 

that five respondents will submit one 

such submission annually, for a total of 

five responses. FDA estimates the 

reporting burden to be 25.0 hours per 

response, for a total burden of 125 

hours. 

Based on the submissions received, 

FDA identified three other tiers of FCNs 

that represent escalating levels of 

burden required to collect information 

(denoted as Categories C, D, and E in the 

third, fourth, and fifth rows of table 1 of 

this document). FDA estimated the 

median number of hours necessary for 

collecting information for each type of 

notification within each of the three 

tiers based on input from industry 

sources. FDA estimates that five 

respondents will submit two Category C 

submissions annually, for a total of ten 

responses. FDA estimates the reporting 

burden to be 120 hours per response, for 

a total burden of 1,200 hours. FDA 

estimates that 33 respondents will 

submit 2 Category D submissions 

annually, for a total of 66 responses. 

FDA estimates the reporting burden to 

be 150 hours per response, for a total 

burden of 9,900 hours. FDA estimates 

that 30 respondents will submit 1 

Category E submission annually, for a 

total of 30 responses. FDA estimates the 

reporting burden to be 150 hours per 

response, for a total burden of 4,500 

hours. 

FDA estimates that two respondents 

will submit one indirect food additive 

petition under § 171.1, for a total of two 

responses. FDA estimates the reporting 

burden to be 10,995 hours per response, 

for a total burden of 21,990 hours. 

FDA estimates that 10 respondents 

will utilize the recommendations in the 

guidance document entitled ‘‘Use of 

Recycled Plastics in Food Packaging: 

Chemistry Considerations,’’ to develop 

the additional information for one such 

submission annually, for a total of 10 

responses. FDA estimates the reporting 

burden to be 25 hours per response, for 

a total burden of 250 hours. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: August 20, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19843 Filed 8–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Subcommittee I—

Career Development, September 30, 

2008, 8 a.m. to October 1, 2008, 5 p.m., 

Crowne Plaza National Airport, 1480 

Crystal Drive, Arlington, VA, 22202 

which was published in the Federal 

Register on August 8, 2008, 73 FR 

46308. 

This meeting is amended to change 

the meeting date to September 30, 2008. 

The meeting is closed to the public. 

Dated: August 20, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–19805 Filed 8–26–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 


sroberts on PROD1PC70 with NOTICES