17868 Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–8818 Filed 4–16–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold a meeting, 

to be held by teleconference. This 

meeting will be equivalent to an inperson meeting and will be open to the 

public. Pre-registration is required for 

both public attendance by phone as well 

as public comment. Any individual who 

wishes to attend the meeting and/or 

participate in the public comment 

session should e-mail nvpo@hhs.gov. 

DATES: The Committee will meet by 

teleconference on May 7, 2009, from 3 

p.m. to 4:30 p.m., Eastern Daylight Time 

(EDT). 

ADDRESSES: The meeting will occur by 

teleconference. To attend, please call 1– 

800–369–1957, passcode ‘‘NVAC’’. 

International callers must dial 1–630– 

395–0286. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Andrea Krull, Public Health Advisor, 

National Vaccine Program Office, 

Department of Health and Human 

Services, Room 715–H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

Phone: (202) 690–5566; Fax: (202) 260– 

1165; e-mail: nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. 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. 

This is a special meeting of the 

NVAC. Discussions will surround the 

draft recommendations on the draft ISO 

Scientific Agenda contained in the 

document titled ‘‘NVAC Vaccine Safety 

Working Group Draft Report’’ prepared 

at the request of the Assistant Secretary 

for Health by the Committee’s Vaccine 

Safety Working Group. The NVAC 

Vaccine Safety Working Group was 

initially established to (1) undertake and 

coordinate a scientific review of the 

draft Centers for Disease Control and 

Prevention (CDC) Immunization Safety 

Office (ISO) Scientific Agenda, and (2) 

review the current vaccine safety 

system. The draft report may be found 

at http://www.hhs.gov/nvpo/nvac/ 

reports.html. The draft ISO Scientific 

Agenda can be found at: http:// 

www.cdc.gov/vaccinesafety/00_pdf/ 

draft_agenda_recommendations_

080404.pdf and the addendum at http:// 

www.cdc.gov/vaccinesafety/00_pdf/

draft_recommendations_add_080410.

pdf. The Committee will review the 

draft document and discuss the 

proposed recommendations in 

preparation for an upcoming vote on 

these recommendations at the June 2009 

NVAC meeting. 

For this special meeting, members of 

the public are invited to attend by 

teleconference via a toll-free call-in 

phone number. The call-in number will 

be operator assisted to provide members 

of the public the opportunity to provide 

comments to the Committee. Public 

participation and ability to comment 

will be limited to space and time 

available. Public comment will be 

limited to no more than three minutes 

per speaker. Pre-registration is required 

for both public attendance and 

comment. Individuals who plan to 

attend and need special assistance, such 

as accommodation for hearing 

impairment or other reasonable 

accommodations, should notify the 

designated contact person at least one 

week prior to the meeting. 

Any members of the public who wish 

to have printed material distributed to 

NVAC should submit materials to the 

Executive Secretary, NVAC, through the 

contact person listed above prior to 

close of business April 30, 2009. A draft 

agenda and any additional materials 

will be posted on the NVAC Vaccine 

Safety Working Group Web site (http:// 

www.hhs.gov/nvpo/nvac/) prior to the 

meeting. 

Dated: April 14, 2009. 

Raymond A. Strikas, 

Medical Officer, National Vaccine Program 

Office, U.S. Department of Health and Human 

Services. 

[FR Doc. E9–8825 Filed 4–16–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Solicitation for Nominations for 

Members of the U.S. Preventive 

Services Task Force (USPSTF) 

Correction 

In notice document E9–8040 

beginning on page 16408 in the issue of 

Friday, April 10, 2009, make the 

following corrections: 

1. On page 16409, in the first column, 

in the fifth line from the top, 

‘‘indMduals’’ should read 

‘‘individuals’’. 

2. On the same page, in the ADDRESSES

section, in the eighth and ninth lines, 

‘‘http://dreamless.keenspot.com/ 

comic.rss’’ should read 

‘‘uspstaskforce@ahrq.hhs.gov’’. 

3. On the same page, in the FOR

FURTHER INFORMATION CONTACT section, 

in the second line, 

‘‘uspstaskforce@ahrg.hhs.gov’’ should 

read ‘‘uspstaskforce@ahrq.hhs.gov’’. 

4. On the same page, in the last full 

paragraph, in the second line from the 

bottom, ‘‘http:// 

preventiveservices.ahrg.gov’’ should 

read ‘‘http:// 

preventiveservices.ahrq.gov’’. 

[FR Doc. Z9–8040 Filed 4–16–09; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0657] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recommendations 

for the Early Food Safety Evaluation of 

New Non-Pesticidal Proteins Produced 

by New Plant Varieties Intended for 

Food Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices 17869 

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 May 18, 

2009. 

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, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0583. Also 

include the FDA 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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recommendations for the Early Food 

Safety Evaluation of New NonPesticidal Proteins Produced by New 

Plant Varieties Intended for Food Use— 

(OMB Control Number 0910–0583)— 

Extension 

Since May 29, 1992 (57 FR 22984), 

when FDA issued a policy statement on 

foods derived from new plant varieties, 

FDA has encouraged developers of new 

plant varieties, including those varieties 

that are developed through 

biotechnology, to consult with FDA 

early in the development process to 

discuss possible scientific and 

regulatory issues that might arise. The 

guidance entitled ‘‘Recommendations 

for the Early Food Safety Evaluation of 

New Non-Pesticidal Proteins Produced 

by New Plant Varieties Intended for 

Food Use’’ continues to foster early 

communication by encouraging 

developers to submit to FDA their 

evaluation of the food safety of their 

new protein. Such communication 

helps to ensure that any potential food 

safety issues regarding a new protein in 

a new plant variety are resolved early in 

development, prior to any possible 

inadvertent introduction into the food 

supply of material from that plant 

variety. 

FDA believes that any food safety 

concern related to such material 

entering the food supply would be 

limited to the potential that a new 

protein in food from the plant variety 

could cause an allergic reaction in 

susceptible individuals or could be a 

toxin. The guidance describes the 

procedures for early food safety 

evaluation of new proteins in new plant 

varieties, including bioengineered food 

plants, and the procedures for 

communicating with FDA about the 

safety evaluation. 

The respondents to this collection of 

information are developers of new plant 

varieties intended for food use. 

In the Federal Register of January 9, 

2009 (74 FR 906), 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: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

First four data components 20 1 20 4 80 

Two other data components 20 1 20 16 320 

Total 400 

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

FDA estimates the annual total hour 

burden for this collection of information 

to be 400 hours. This estimate is based 

on early food safety evaluations 

submitted in the past 3 years. FDA’s 

estimate of the time that it would take 

a respondent to prepare the data 

components of the early food safety 

evaluation submission is based on the 

agency’s experience with similar 

submissions. 

Completing an early food safety 

evaluation for a new protein from a new 

plant variety is a one-time burden (one 

evaluation per new protein). Based on 

its experience over the past 3 years, 

FDA estimates that approximately 20 

developers will choose to complete an 

early food safety evaluation for their 

new plant protein. Many developers of 

novel plants may choose not to submit 

an evaluation because the field testing 

of a plant containing a new protein is 

conducted in such a way (e.g., on such 

a small scale, or in such isolated 

conditions, etc.) that cross-pollination 

with traditional crops or commingling 

of plant material is not likely to be an 

issue. Also, other developers may have 

previously communicated with FDA 

about the food safety of a new plant 

protein, for example, when the same 

protein was expressed in a different 

crop. 

The early food safety evaluation for 

new proteins includes six main data 

components. Four of these data 

components are easily and quickly 

obtainable, having to do with the 

identity and source of the protein. FDA 

estimates that completing these data 

components will take about 4 hours per 

evaluation. In table 1 of this document, 

row 1 shows that for 20 evaluations, the 

total burden for these 4 data 

components is 80 hours. 

Two data components ask for original 

data to be generated. One data 

component consists of a bioinformatics 

analysis which can be performed using 

publicly available databases. The other 

data component involves ‘‘wet’’ lab 

work to assess the new protein’s 

stability and the resistance of the 

protein to enzymatic degradation using 

appropriate in vitro assays (protein 

digestibility study). The paperwork 

burden of these two data components 

consists of the time it takes the company 

to assemble the information on these 

two data components to submit to FDA. 

We estimate that these two data 

components will take 16 hours to 

complete (8 hours for each component). 

In table 1 of this document, row 2 shows 

that for 20 evaluations, the total burden 

for these two data components is 320 

hours. 

Dated: April 10, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8773 Filed 4–16–09; 8:45 am] 

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mstockstill on PROD1PC66 with NOTICES