52954 Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 

Questionnaire has been developed by 

the NEDSS program to gather 

information needed for formulating a 

technical and project management 

support strategy for 57 reporting 

jurisdictions (i.e., 50 states, 5 territories, 

and 2 cities (New York City, NY and 

Washington, DC)) as they implement 

NEDSS messaging using MMGs. A 

jurisdiction’s response to the 

questionnaire will be used by the 

NEDSS implementation and 

management teams to assess the 

jurisdiction’s IT system environment 

and capacity and help determine the 

project schedule and level of human 

and technical support needed to 

complete the jurisdiction’s 

implementation of a nationally 

notifiable condition message. NEDSS 

infrastructure implementation support 

includes, but is not limited to 

implementing NEDSS Message 

Subscription Service (MSS) and NEDSS 

Messaging Solution (NMS) software in 

requesting jurisdictions; providing MSS 

and NMS software training and ongoing 

technical support; and distributing 

funding via the CDC Epidemiology and 

Laboratory Capacity cooperative 

agreement. 

Questionnaires will be distributed to 

jurisdictions that initiate MMG 

implementation for a condition; 

therefore, the maximum annual 

frequency of responses per jurisdiction 

is three. The NEDSS team will request 

the jurisdiction to voluntarily complete 

the questionnaire, but a response is not 

a pre-requisite for support. 

There is no cost to respondents other 

than their time to participate in the 

survey. The total estimated annual 

burden hours are 114. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

State, Territory and Local Public Health Department.National Notifiable Condition Messaging 

Support Strategy Questionnaire.

57 3 40/60 

Dated: August 23, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–21497 Filed 8–27–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0258] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Submission of 

Petitions: Food Additive, Color 

Additive (Including Labeling), and 

Generally Recognized as Safe 

Affirmation; Submission of Information 

to a Master File in Support of Petitions; 

Electronic Submission Using Food and 

Drug Administration Form 3503 

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 September 

29, 2010. 

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: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0016. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Submission of Petitions: Food Additive, 

Color Additive (Including Labeling), 

and Generally Recognized as Safe 

Affirmation; Submission of Information 

to a Master File in Support of Petitions; 

Electronic Submission Using FDA Form 

3503—21 CFR 70.25, 71.1, 170.35, 

171.1, 172, 173, 179, and 180 (OMB 

Control Number 0910–0016)—Revision 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe, 

unless: (1) The additive and its use, or 

intended use, are in conformity with a 

regulation issued under section 409 of 

the FD&C Act that describes the 

condition(s) under which the additive 

may be safely used; (2) the additive and 

its use, or intended use, conform to the 

terms of an exemption for 

investigational use; or (3) a food contact 

notification submitted under section 

409(h) of the FD&C Act is effective. 

Food additive petitions (FAPs) are 

submitted by individuals or companies 

to obtain approval of a new food 

additive or to amend the conditions of 

use permitted under an existing food 

additive regulation. Section 171.1 of 

FDA’s regulations (21 CFR 171.1) 

specifies the information that a 

petitioner must submit in order to 

establish that the proposed use of a food 

additive is safe and to secure the 

publication of a food additive regulation 

describing the conditions under which 

the additive may be safely used. Parts 

172, 173, 179, and 180 (21 CFR parts 

172, 173, 179, and 180) contain labeling 

requirements for certain food additives 

to ensure their safe use. 

Section 721(a) of the FD&C Act (21 

U.S.C. 379e(a)) provides that a color 

additive shall be deemed to be unsafe 

unless the additive and its use are in 

conformity with a regulation that 

describes the condition(s) under which 

the additive may safely be used, or the 

additive and its use conform to the 

terms of an exemption for 

investigational use issued under section 

721(f) of the FD&C Act. Color additive 

petitions (CAPs) are submitted by 

individuals or companies to obtain 

approval of a new color additive or a 

change in the conditions of use 

permitted for a color additive that is 

already approved. Section 71.1 of the 

agency’s regulations (21 CFR 71.1) 

specifies the information that a 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 52955 

petitioner must submit to establish the 

safety of a color additive and to secure 

the issuance of a regulation permitting 

its use. FDA’s color additive labeling 

requirements in § 70.25 (21 CFR 70.25) 

require that color additives that are to be 

used in food, drugs, devices, or 

cosmetics be labeled with sufficient 

information to ensure their safe use. 

FDA scientific personnel review FAPs 

to ensure the safety of the intended use 

of the additive in or on food or that may 

be present in food as a result of its use 

in articles that contact food. Likewise, 

FDA personnel review color additive 

petitions to ensure the safety of the 

color additive prior to its use in food, 

drugs, cosmetics, or medical devices. 

Under section 201(s) of the FD&C Act 

(21 U.S.C. 321(s)), a substance is 

Generally Recognized as Safe (GRAS) if 

it is generally recognized among experts 

qualified by scientific training and 

experience to evaluate its safety, to be 

safe through either scientific procedures 

or common use in food. The FD&C Act 

historically has been interpreted to 

permit food manufacturers to make their 

own initial determination that use of a 

substance in food is GRAS and 

thereafter seek affirmation of GRAS 

status from FDA. FDA reviews petitions 

for affirmation of GRAS status that are 

submitted on a voluntary basis by the 

food industry and other interested 

parties under authority of sections 201, 

402, 409, and 701 of the FD&C Act (21 

U.S.C. 321, 342, 348, and 371). To 

implement the GRAS provisions of the 

act, FDA has set forth procedures for the 

GRAS affirmation petition process in 

§ 170.35(c)(1) of its regulations (21 CFR 

170.35(c)(1)). While the GRAS 

affirmation petition process still exists, 

FDA has not received a GRAS 

affirmation petition since the 

establishment of the voluntary GRAS 

notification program and is not 

expecting any during the period covered 

by this proposed extension of collection 

of information. 

Currently, interested persons may 

transmit regulatory submissions to the 

Office of Food Additive Safety in the 

Center for Food Safety and Applied 

Nutrition using Form FDA 3503 for FAP 

and Form FDA 3504 for CAP. FDA is 

revising Form FDA 3503 to better enable 

its use for electronic submission and to 

permit its use for multiple types of 

submissions, which eliminates the need 

for Form FDA 3504. Because Form FDA 

3503 helps the respondent organize 

their submission to focus on the 

information needed for FDA’s safety 

review, FDA now recommends that this 

form be used for FAPs and CAPs, 

whether submitted in electronic format 

or paper format. FDA estimates that the 

amount of time for respondents to 

complete the revised FDA Form 3503 

will continue to be 1 hour. The revised 

Form FDA 3503 can be used to submit 

information to FDA in electronic format 

using the Electronic Submission 

Gateway portal. The revised Form FDA 

3503 can be used to substitute for the 

‘‘Dear Sir’’ section of 21 CFR 71.1(c) for 

a CAP and 21 CFR 171.1(c) for a FAP. 

The revised Form FDA 3503 provides 

for submitters to indicate the date of 

their most recent presubmission 

consultation activity with FDA. The 

revised Form FDA 3503 can also be 

used to organize information within a 

Master File submitted in support of 

petitions according to the items listed 

on the form. Master Files can be used as 

repositories for information that can be 

referenced in multiple submissions to 

the Agency, thus minimizing paperwork 

burden for food and color additive 

approvals. The revised Form FDA 3503 

is formatted to accept submissions for 

both FAP and CAP, thus making 

redundant Form FDA 3504 for 

collecting CAP submissions. Therefore, 

FDA is eliminating Form FDA 3504. 

Description of respondents: 

Respondents are businesses engaged in 

the manufacture or sale of food, food 

ingredients, color additives, or 

substances used in materials that come 

into contact with food. 

In the Federal Register of June 14, 

2010 (75 FR 33624), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

FDA Form 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 

Total Operating and 

Maintenance Costs 

Total 

Hours 

70.25, 71.1 2 1 2 1,337 $5,600 2,674 

GRAS Affirmation Petitions 

170.35 1 or fewer 1 1 or fewer 2,614 0 2,614 

FAPs 

171.1 3 1 3 7,093 0 21,279 

FDA Form 3503 6 1 6 1 0 6 

Total $5,600 26,573 

1There are no capital costs associated with this collection of information. 

The estimate of burden for food 

additive, color additive, or GRAS 

affirmation petitions is based on FDA’s 

experience and the average number of 

new petitions received in calendar years 

2006, 2007, 2008, and 2009, and the 

total hours expended in preparing the 

petitions. In compiling these estimates, 

FDA consulted its records of the number 

of petitions received in the past 4 years. 

The figures for ‘‘Hours per Response’’ are 

based on estimates from experienced 

persons in the Agency and in industry. 

Although the estimated hour burden 

varies with the type of petition 

submitted, an average petition involves 

analytical work and appropriate 

toxicological studies, as well as the 

work of drafting the petition itself. The 

burden varies depending on the 

complexity of the petition, including the 

amount and types of data needed for 

scientific analysis. 

Color additives are subjected to 

payment of fees for the petitioning 

process. The listing fee for a color 

additive petition ranges from $1,600 to 


jlentini on DSKJ8SOYB1PROD with NOTICES
52956 Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 

$3,000, depending on the intended use 

of the color and the scope of the 

requested amendment. A complete 

schedule of fees is set forth in 21 CFR 

70.19. An average of one Category A and 

one Category B color additive petition is 

expected per year. The maximum color 

additive petition fee for a Category A 

petition is $2,600 and the maximum 

color additive petition fee for a Category 

B petition is $3,000. Because an average 

of two color additive petitions are 

expected per calendar year, the 

estimated total annual cost burden to 

petitioners for this startup cost would be 

less than or equal to $5,600 (1 x $2,600 

+ 1 x $3,000 listing fees = $5,600). There 

are no capital costs associated with 

color additive petitions. 

The labeling requirements for food 

and color additives were designed to 

specify the minimum information 

needed for labeling in order that food 

and color manufacturers may comply 

with all applicable provisions of the 

FD&C Act and other specific labeling 

acts administered by FDA. Label 

information does not require any 

additional information gathering beyond 

what is already required to assure 

conformance with all specifications and 

limitations in any given food or color 

additive regulation. Label information 

does not have any specific 

recordkeeping requirements unique to 

preparing the label. Therefore, because 

labeling requirements under § 70.25 for 

a particular color additive involve 

information required as part of the CAP 

safety review process, the estimate for 

number of respondents is the same for 

§§ 70.25 and 71.1, and the burden hours 

for labeling are included in the estimate 

for § 71.1. Also, because labeling 

requirements under parts 172, 173, 179, 

and 180 for particular food additives 

involve information required as part of 

the FAP safety review process under 

§ 171.1, the burden hours for labeling 

are included in the estimate for § 171.1. 

Dated: August 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–21388 Filed 8–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Funding Opportunity 

Purpose of Notice: Availability of 

funding opportunity announcement. 

Funding Opportunity Title/Program 

Name: Older Americans Act (OAA), 

Title VI, Part A: Grants for Native 

Americans; Part B: Grants for Native 

Hawaiian Programs; and Part C: Grants 

for the Native American Caregiver 

Support Program. 

Announcement Type: This is the 

initial announcement for this funding 

opportunity. 

Funding Opportunity Number: 

Program Announcement No. is HHS– 

2011–AoA–TitleVI–1101. 

Statutory Authority: The Older 

Americans Act, Public Law 109–365. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.047, 

Title VI Parts A and B and 93.054, Title 

VI Part C. 

Dates: The deadline date for the 

submission of applications is November 

30, 2010. 

I. Funding Opportunity Description 

This announcement seeks proposals 

for grants to provide nutritional and 

supportive services to Indian elders and 

Alaskan Natives under Part A; Native 

Hawaiian elders under Part B; and 

Family Caregiver support services under 

Part C of the OAA. The goal of these 

programs is to increase home and 

community-based services to older 

Indians, Alaskan Natives and Native 

Hawaiians, that respond to local needs 

and are consistent with evidence-based 

practices. A detailed description of the 

funding opportunity may be found at 

http://www.grants.gov, http:// 

www.aoa.gov under Grant Opportunities 

→Funding Opportunities, or http:// 

www.olderindians.org. 

II. Award Information 

1. Funding Instrument Type 

Grant. 

2. Anticipated Total Priority Area 

Funding per Budget Period 

The Administration on Aging (AoA) 

will accept applications for funding for 

a three-year project period, April 1, 

2011 to March 31, 2014, in FY 2011 

under the OAA, Title VI, Part A: Grants 

for Native Americans; Part B: Grants for 

Native Hawaiian Programs; and Part C: 

Grants for the Native American 

Caregiver Support Program. Current 

annual funding levels for Title VI, Part 

A and Part B range from $76,160 to 

$186,000. Current annual funding levels 

for Title VI, Part C range from $14,410 

to $57,680. Distribution of funds among 

tribal organizations and Native 

Hawaiian organizations is subject to the 

availability of appropriations to carry 

out Title VI. Funding is based on the 

number of eligible elders age 60 and 

older in your proposed service area. 

Successful applications from current 

grantees will receive priority 

consideration. Successful applications 

from new applicants will be funded 

pending the availability of funds or at 

the discretion of the Assistant Secretary 

for Aging. For those applying for Title 

VI, Parts A or B funding you have the 

option to also apply for Part C. 

However, to apply for Part C, you must 

apply for both Part A and Part C or Part 

B and Part C. 

III. Eligibility Criteria and Other 

Requirements 

1. Eligible Applicants 

Eligibility for grant awards is limited 

to all current Title VI, Part A and Part 

B grantees; current grantees who wish to 

leave a consortium; and eligible 

federally recognized Indian tribal 

organizations that are not now 

participating in Title VI and would like 

to apply as a new grantee. Those tribes 

who were a part of a consortium 

receiving a Title VI grant in 1991 and 

applying individually will be 

considered a ‘‘current grantee.’’ Proof of 

being a part of a consortium that was 

funded in FY 1991 must be submitted 

as part of the application. A tribal 

organization or Indian tribe must meet 

the application requirements contained 

in sections 612(a), 612(b), and 612(c) of 

the OAA and 45 CFR 1326.19. A public 

or nonprofit private organization serving 

Native Hawaiians must meet the 

application requirements contained in 

sections 622(1), 622(2), and 625 of the 

OAA and 45 CFR 1328.19. Under the 

Native American Caregiver Support 

Program, a tribal or Native Hawaiian 

organization must meet the 

requirements as contained in section 

631 of the OAA. These sections are 

described in the application kit. 

2. Cost Sharing or Matching 

Cost Sharing or matching does not 

apply to these grants. 

3. D–U–N–S Number 

All grant applicants must obtain a 

D–U–N–S number from Dun and 

Bradstreet. It is a nine-digit 

identification number, which provides 

unique identifiers of single business 

entities. The D–U–N–S number is free 

and easy to obtain from http:// 

www.dnb.com/US/duns_update/ or by 

calling their live help line at 1–888– 

814–1435. Applicants are also 

encouraged to check their Web site for 

other pertinent information regarding 

this process. 

4. Intergovernmental Review 

Executive Order 12372, 

Intergovernmental Review of Federal 


jlentini on DSKJ8SOYB1PROD with NOTICES