Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices 20553 

understanding the health effects of 

asbestos and mineral fibers, and 

(5) The appropriateness and relevancy 

of the discussion of the path forward 

and whether the ultimate vision is a 

reasonable outcome for the proposed 

research strategy for asbestos and 

mineral fibers. 

Status: The forum will include 

scientists and representatives from 

various government agencies, industry, 

labor, and other stakeholders, and is 

open to the public, limited only by the 

space available. Persons wanting to 

attend and provide oral comments at the 

meeting are requested to notify Diane 

Miller no later than May 1, 2007 to 

reserve time for their comments. Those 

interested in attending without 

providing oral comments at the meeting 

also are requested to notify Ms. Miller 

by May 1, 2007 to reserve a seat. Ms. 

Miller can be reached by telephone at 

513/533–8450 or by e-mail at 

niocindocket@cdc.gov. Priority for 

attendance will be given to those 

providing oral comments. Other 

requests to attend the meeting will then 

be accommodated on a first-come basis. 

Unreserved walk-in attendees will be 

accommodated on the day of the 

meeting if space is available. 

Persons wanting to provide oral 

comments will be permitted up to 15 

minutes. If additional time becomes 

available, presenters will be notified. 

Oral comments given at the meeting will 

be recorded and included in the docket. 

Written comments will also be accepted 

at the meeting. Written comments may 

also be submitted to Diane Miller, 

Robert A. Taft Laboratories, 4676 

Columbia Parkway, MS C–34, 

Cincinnati, Ohio 45226, telephone 513/ 

533–8450. All material submitted to the 

Agency should reference docket number 

NIOSH–099 and must be submitted by 

May 31, 2007 (public review closing 

date) to be considered by the Agency. 

All electronic comments should be 

formatted as Microsoft Word. Please 

make reference to docket number 

NIOSH–099. 

NIOSH seeks to obtain materials, 

including published and unpublished 

reports and research findings, relevant 

to the characterization of exposures and 

possible health risks of occupational 

exposure to asbestos and other mineral 

fibers. Examples of requested 

information include, but are not limited 

to, the following: 

(1) Identification of industries, 

occupations, and processes where 

exposure to mineral fibers may occur, 

including exposure to fiber-like cleavage 

fragments and thoracic-sized fibers (as 

defined in the draft NIOSH document). 

(2) Current and historical mineral 

fibers exposure measurement data, 

including exposure to fiber-like cleavage 

fragments and thoracic-sized fibers at 

various types of industries and jobs. 

(3) Case reports or other health 

information demonstrating health 

effects in workers exposed to mineral 

fibers, including exposure to fiber-like 

cleavage fragments and thoracic-sized 

fibers. 

(4) Reports of experimental in vivo, in 

vitro, and inhalation studies with 

rodents that provide evidence of 

biopersistence and/or of a doserelationship between the particle 

dimension (e.g., fiber) of the mineral 

and its biological activity. 

(5) Information on sampling and 

analytical methods that could be used to 

improve the identification and 

differentiation of ‘‘fibers’’ of different 

dimensions and composition. 

(6) Information on technologies that 

could be used to separate thoracic-sized 

fibers, including fiber-like cleavage 

fragments, into discrete size dimensions 

in quantities sufficient for conducting 

chronic rodent inhalation studies. 

NIOSH will use this information to 

assess the scientific basis for the draft 

document and the need to revise 

research recommendations. 

Contact Person for Technical 

Information: Paul Middendorf, 

telephone (513) 533–8606, M/S C–9, 

Robert A. Taft Laboratories, 4676 

Columbia Parkway, Cincinnati, Ohio 

45226. 

Contact Person for Submitting 

Comments/Meeting Attendance: Diane 

Miller, Robert A. Taft Laboratories, 4676 

Columbia Parkway, M/S C–34, 

Cincinnati, Ohio 45226, telephone (513) 

533–8450. All material submitted to the 

Agency should reference Docket 

Number NIOSH–099. 

All information received in response 

to this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, 4676 Columbia Parkway, 

Cincinnati, Ohio 45226. 

Dated: April 18, 2007. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E7–7882 Filed 4–24–07; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0014] 

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; Electronic Submission 

Using Food and Drug Administration 

Forms 3503 and 3504 

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 May 25, 

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. 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: 

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. 

Submission of Petitions: Food Additive, 

Color Additive (Including Labeling), 

and Generally Recognized as Safe 

Affirmation; Electronic Submission 

Using Food and Drug Administration 

Forms 3503 and 3504 (OMB Control 

Number 0910–0016)—Extension 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (the 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 


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20554 Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices 

the 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 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 (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 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 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 (21 CFR 

71.1) specifies the information that a 

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. 

Under section 201(s) of the 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 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 

act (21 U.S.C. 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) (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. 

In the Federal Register of July 31, 

2001 (66 FR 39517), FDA announced the 

availability of a draft guidance entitled 

‘‘Draft Guidance for Industry on 

Providing Regulatory Submissions to 

Office of Food Additive Safety in 

Electronic Format for Food Additive 

and Color Additive Petitions.’’ This 

guidance describes the procedures for 

electronic submission of FAPs and 

CAPs using FDA Form 3503 and FDA 

Form 3504, respectively. 

FDA scientific personnel review food 

and color additive and GRAS 

affirmation petitions to ensure the safety 

of the intended use of the substance in 

or on food, or of a food additive that 

may be present in food as a result of its 

use in articles that contact food (or for 

color additives, its use in food, drugs, 

cosmetics, or medical devices). 

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 January 19, 

2007 (72 FR 2533), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. FDA received one comment 

that was outside the scope of the request 

for comments. 

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 & 

Maintenance Costs Total Hours 

CAPs 

70.25, 71.1 3 1 3 1,337 $8,200 4,010 

FDA Form 3504 1 1 1 1 0 1 

GRAS Affirmation Petitions 

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

FAPs 

171.1 6 1 6 7,093 0 42,560 

FDA Form 3503 1 1 1 1 0 1 

Total $8,200 49,186 

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 

2003, 2004, and 2005, 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 3 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 


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Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices 20555 

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 

$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 two category A and 

one category B color additive petitions 

are 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. Since an average of 

3 color additive petitions are expected 

per calendar year, the estimated total 

annual cost burden to petitioners for 

this start-up cost would be less than or 

equal to $8,200 ((2 x $2,600) + (1 x 

$3,000) = $8,200)). There are no capital 

costs associated with color additive 

petitions. 

The estimated burden reported in 

table 1 of this document does not 

include the previously estimated burden 

for the preparation of FAPs submitted to 

amend parts 175 through 178 (21 CFR 

parts 175 through 178). The burden to 

respondents is similar between the 

preparation of petitions submitted to 

amend parts 175 through 178 and the 

preparation of a food contact substance 

notification. In this request for 

extension of OMB approval for the 

collection of information for FAPs, FDA 

proposes to transfer the collection of 

information and burden associated with 

petitions submitted to amend the 

indirect food additive regulations (parts 

175 through 178) from this collection of 

information (OMB control number 

0910–0016) to the existing collection of 

information for the Food Contact 

Substances Notification System (OMB 

control number 0910–0495). 

FDA estimates the annual reporting 

burden associated with petitions 

submitted to amend parts 175 through 

178 to be transferred from OMB control 

number 0910–0016 to OMB control 

number 0910–0495. An average of two 

indirect food additive petitions are 

expected per calendar year. The 

estimated total annual hour burden to 

petitioners per petition is 10,995 hours, 

for a total burden of 21,990 hours. There 

are no capital costs or operating and 

maintenance costs associated with the 

burden hours being transferred from 

OMB control number 0910–0016 to 

OMB control number 0910–0495. 

Electronic submissions of petitions 

contain the same petition information 

required for paper submissions. The 

agency estimates that one petitioner for 

both food and color additives will take 

advantage of the electronic submission 

process per year. By using the 

guidelines and forms that FDA is 

providing, the petitioner will be able to 

organize the petition to focus on the 

information needed for FDA’s safety 

review. Therefore, we estimate that 

petitioners will only need to spend 

approximately 1 hour completing the 

electronic submission application form 

(Form 3503 or 3504, as appropriate) 

because they will have already used the 

guidelines to organize the petition 

information needed for the submission. 

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 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 under § 70.25, 

labeling requirements 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. 

In cases where a regulation 

implements a statutory information 

collection requirement, only the 

additional burden attributable to the 

regulation, if any, has been included in 

FDA’s burden estimate. 

Dated: April 18, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–7813 Filed 4–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0475] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Tissue 

Intended for Transplantation 

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 May 25, 

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. All comments should be 

identified with the OMB control number 

0910–0302. Also include the FDA 

docket number found in brackets in the 

heading of this document. 

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. 

Human Tissue Intended for 

Transplantation (OMB Control Number 

0910–0302)—Extension 

Under section 361 of the Public 

Health Service (PHS) Act (42 U.S.C. 

264), FDA issued regulations to prevent 

the transmission of human 

immunodeficiency virus (HIV), hepatitis 

B, and hepatitis C, through the use of 

human tissue for transplantation. The 

regulations provide for inspection by 

FDA of persons and tissue 

establishments engaged in the recovery, 

screening, testing, processing, storage, 

or distribution of human tissue. These 

facilities are required to meet provisions 

intended to ensure appropriate 

screening and testing of human tissue 

donors and to ensure that records are 


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