Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Notices 2533 

CMS, Office of Strategic Operations and 

Regulatory Affairs, Division of 

Regulations Development—A, 

Attention: Melissa Musotto, Room 

C4–26–05, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

Dated: January 12, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–700 Filed 1–18–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0014] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 information collection provisions of 

FDA’s regulations for submission of 

petitions, including food and color 

additive petitions (including labeling) 

and generally recognized as safe (GRAS) 

affirmations, and electronic submission 

using FDA Forms 3503 and 3504. This 

notice also notifies the public of, and 

solicits comments on, FDA’s proposal to 

transfer the collection of information 

and burden associated with petitions 

submitted to amend the indirect food 

additive regulations from the subject 

collection of information Office of 

Management and Budget (OMB) control 

number 0910–0016 to the collection of 

information for the Food Contact 

Substances Notification System (OMB 

control number 0910–0495). 

DATES: Submit written or electronic 

comments on the collection of 

information by March 20, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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 the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from 

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. 

Submission of Petitions: Food Additive, 

Color Additive (Including Labeling), 

and GRAS Affirmation; Electronic 

Submission Using FDA Forms 3503 and 

3504—21 CFR 70.25, 71.1, 170.35, 

171.1, 172, 173, 179, and 180 (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 

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 GRAS if it 

is generally recognized among experts 


sroberts on PROD1PC70 with NOTICES
2534 Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Notices 

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. 

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) (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. 

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 

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 

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 

three 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 throuhg 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 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Notices 2535 

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: January 12, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–681 Filed 1–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

Determination Pursuant to Section 102 

of the Illegal Immigration Reform and 

Immigrant Responsibility Act of 1996 

as Amended by Section 102 of the 

REAL ID Act of 2005 and as Amended 

by the Secure Fence Act of 2006 

AGENCY: Office of the Secretary, 

Department of Homeland Security. 

ACTION: Notice of determination. 

SUMMARY: The Secretary of Homeland 

Security has determined, pursuant to 

law, that it is necessary to waive certain 

laws, regulations and other legal 

requirements in order to ensure the 

expeditious construction of physical 

barriers and roads in the vicinity of the 

international land border of the United 

States in Arizona. The Secretary’s 

waiver is effective upon publication of 

this Notice. 

DATES: This Notice is effective on 

January 19, 2007. 

Determination and Waiver: In section 

102(a) of the Illegal Immigration Reform 

and Immigrant Responsibility Act of 

1996 (IIRIRA), Public Law 104–208, Div. 

C, 110 Stat. 3009–546, 3009–554 (Sept. 

30, 1996) (8 U.S.C. 1103, note), Congress 

provided that the Attorney General shall 

take such actions as may be necessary 

to install additional physical barriers 

and roads (including the removal of 

obstacles to detection of illegal entrants) 

in the vicinity of the United States 

border to deter illegal crossings in areas 

of high illegal entry into the United 

States. Pursuant to sections 1511 and 

1517 of the Homeland Security Act of 

2002 (HSA), Public Law 107–296, 116 

Stat. 2135, 2309, 2311 (Nov. 25, 2002) 

(6 U.S.C. 551, 557), the authorities of the 

Attorney General contained in section 

102 of the IIRIRA were transferred to the 

Secretary of Homeland Security 

(Secretary). 

In section 3 of the Secure Fence Act 

of 2006 (Secure Fence Act), Public Law 

109–367), Congress amended Section 

102(b) of IIRIRA to provide for the 

installation of fencing, barriers, roads, 

lighting, cameras, and sensors along five 

segments of the southern border of the 

United States, including much of the 

border between Arizona and Mexico. In 

section 102(c) of the IIRIRA, as amended 

by section 102 of the REAL ID Act of 

2005, Public Law 109–13, Div. B, 119 

Stat. 231, 302, 306 (May 11, 2005) 

(REAL ID Act) (8 U.S.C. 1103 note), 

Congress granted the Secretary 

‘‘authority to waive all legal 

requirements such Secretary, in such 

Secretary’s sole discretion, determines 

necessary to ensure the expeditious 

construction of barriers and roads 

under’’ section 102 of IIRIRA. 

I have determined that the area in the 

vicinity of the United States border 

known as the Barry M. Goldwater Range 

(BMGR), as described in the Bureau of 

Land Management’s ‘‘Legal Description 

of Barry M. Goldwater Range 

Withdrawal, AZ’’ (66 FR 59813 

(November 30, 2001)), in southwestern 

Arizona, including the adjacent area to 

the west of the BMGR, is an area of high 

illegal entry. This area is also within the 

footprint of infrastructure provided for 

in Section 102(b)(1)(A)(ii) of IIRIRA as 

amended by the Secure Fence Act. 

There is presently a need to construct 

fixed and mobile barriers (such as 

fencing, vehicle barriers, towers, 

sensors, cameras, and other 

surveillance, communication, and 

detection equipment) and roads in the 

vicinity of the border of the United 

States within and in the vicinity of the 

BMGR. In order to ensure the 

expeditious construction of the barriers 

and roads that Congress prescribed in 

sections 102(a) and 102(b) of the IIRIRA 

in the BMGR, which is an area of high 

illegal entry into the United States, I 

have determined that it is necessary to 

exercise the authority that was 

transferred to me by sections 1511 and 

1517 of the HSA and that is vested in 

me by section 102(c) of the IIRIRA as 

amended by section 102 of the REAL ID 

Act. 

Accordingly, with respect to the 

construction, as prescribed in sections 

102(a) and 102(b) of the IIRIRA, of roads 

and fixed and mobile barriers within the 

BMGR and within five miles to the west 

of the BMGR (including, but not limited 

to, accessing the project area, the 

conduct of earthwork, excavation, fill, 

and site preparation, and installation 

and upkeep of fences, roads, supporting 

elements, drainage, erosion controls, 

safety features, surveillance, 

communication, and detection 

equipment of all types, radar and radio 

towers, and lighting), I hereby waive, in 

their entirety, all Federal, State, or other 

laws, regulations and legal requirements 

of, deriving from, or related to the 

subject of, the following laws, as 

amended: the National Environmental 

Policy Act (Pub. L. 91–190, 83 Stat. 852, 

(Jan. 1, 1970) (42 U.S.C. 4321 et seq.)); 

the Endangered Species Act (Pub. L. 93–

205, 87 Stat. 884 (Dec. 28, 1973) (16 

U.S.C. 1531 et seq.)); the Federal Water 

Pollution Control Act (commonly 

referred to as the Clean Water Act) (Act 

of June 30, 1948, c. 758, 62 Stat. 1155 

(33 U.S.C. 1251 et seq.)); the Wilderness 

Act (Pub. L. 88–577, 16 U.S.C. 1131 et 


sroberts on PROD1PC70 with NOTICES