Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 14581 

[FR Doc. E7–5631 Filed 3–27–07; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0091] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Preparing a Claim 

of Categorical Exclusion or an 

Environmental Assessment for 

Submission to the Center for Food 

Safety and Applied Nutrition 

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 in 

the guidance document entitled 

‘‘Preparing a Claim of Categorical 

Exclusion or an Environmental 

Assessment for Submission to the 

Center for Food Safety and Applied 

Nutrition.’’

DATES: Submit written or electronic 

comments on the collection of 

information by May 29, 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 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. 

Preparing a Claim of Categorical 

Exclusion or an Environmental 

Assessment for Submission to the 

Center for Food Safety and Applied 

Nutrition (OMB Control Number 0910–

0541)—Extension 

As an integral part of its 

decisionmaking process, FDA is 

obligated under the National 

Environmental Policy Act of 1969 

(NEPA) to consider the environmental 

impact of its actions, including allowing 

notifications for food contact substances 

to become effective and approving food 

additive petitions, color additive 

petitions, GRAS affirmation petitions, 

requests for exemption from regulation 

as a food additive, and actions on 

certain food labeling citizen petitions, 

nutrient content claims petitions, and 

health claims petitions. In 1997, FDA 

amended its regulations in part 25 (21 

CFR part 25) to provide for categorical 

exclusions for additional classes of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment (62 FR 40570, 

July 29, 1997). As a result of that 

rulemaking, FDA no longer routinely 

requires submission of information 

about the manufacturing and production 

of FDA-regulated articles. FDA also has 

eliminated the previously required 

Environmental Assessment (EA) and 

abbreviated EA formats from the 

amended regulations. Instead, FDA has 

provided guidance that contains sample 

formats to help industry submit a claim 

of categorical exclusion or an EA to 

CFSAN. The guidance document 

entitled ‘‘Preparing a Claim of 

Categorical Exclusion or an 

Environmental Assessment for 

Submission to the Center for Food 

Safety and Applied Nutrition’’

identifies, interprets, and clarifies 

existing requirements imposed by 

statute and regulation, consistent with 

the Council on Environmental Quality 

regulations (40 CFR 1507.3). It consists 

of recommendations that do not 

themselves create requirements; rather, 

they are explanatory guidance for FDA’s 

own procedures in order to ensure full 

compliance with the purposes and 

provisions of NEPA. 

The guidance provides information to 

assist in the preparation of claims of 

categorical exclusion and EAs for 

submission to CFSAN. The following 

questions are covered in this guidance: 

(1) What types of industry-initiated 

actions are subject to a claim of 

categorical exclusion? (2) What must a 

claim of categorical exclusion include 

by regulation? (3) What is an EA? (4) 

When is an EA required by regulation 

and what format should be used? (5) 

What are extraordinary circumstances? 

and (6) What suggestions does CFSAN 

have for preparing an EA? Although 

CFSAN encourages industry to use the 

EA formats described in the guidance 

because standardized documentation 

submitted by industry increases the 

efficiency of the review process, 

alternative approaches may be used if 

these approaches satisfy the 

requirements of the applicable statutes 

and regulations. 

FDA is requesting the extension of 

OMB approval for the information 

collection provisions in the guidance. 

Description of Respondents: The 

likely respondents include businesses 

engaged in the manufacture or sale of 

food, food ingredients, and substances 

used in materials that come into contact 

with food. 

FDA estimates the burden of this 

collection of information as follows: 


sroberts on PROD1PC70 with NOTICES
14582 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 

Total Burden 

Hours 

25.32(i) 52 3 156 1 156 

25.32(o) 1 1 1 1 1 

25.32(q) 7 2 14 1 14 

Total 171 171 

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

The above estimates for respondents 

and numbers of responses are based on 

the annualized numbers of petitions and 

notifications qualifying for § 25.32(i) 

and (q) that the agency has received in 

the past 3 years. Please note that, in the 

past 3 years, there have been no 

submissions that requested an action 

that would have been subject to the 

categorical exclusion in § 25.32(o). To 

avoid counting this burden as zero, FDA 

has estimated the burden for this 

categorical exclusion at one respondent 

making one submission a year for a total 

of one annual submission. 

To calculate the estimate for the hours 

per response values, we assumed that 

the information requested in this 

guidance for each of these three 

categorical exclusions is readily 

available to the submitter. For the 

information requested for the exclusion 

in § 25.32(i), we expect that submitter 

will need to gather information from 

appropriate persons in the submitter’s 

company and to prepare this 

information for attachment to the claim 

for categorical exclusion. We believe 

that this effort should take no longer 

than 1 hour per submission. For the 

information requested for the exclusions 

in § 25.32(o) and (q), the submitters will 

almost always merely need to copy 

existing documentation and attach it to 

the claim for categorical exclusion. We 

believe that collecting this information 

should also take no longer than 1 hour 

per submission. 

Dated: March 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5634 Filed 3–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. 2003E–0243 and 2003E–0244] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; INFUSE BONE GRAFT/LT–

CAGE LUMBAR TAPERED FUSION 

DEVICE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for INFUSE 

BONE GRAFT/LT–CAGE LUMBAR 

TAPERED FUSION DEVICE and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of two applications to 

the Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of patents which claim that 

medical device. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 

FDA recently approved for marketing 

the medical device INFUSE BONE 

GRAFT/LT–CAGE LUMBAR TAPERED 

FUSION DEVICE. INFUSE BONE 

GRAFT/LT–CAGE LUMBAR TAPERED 

FUSION DEVICE is indicated for spinal 

fusion procedures in skeletally mature 

patients with degenerative disc disease 

(DDD) at one level from L4—S1. 

Subsequent to this approval, the Patent 

and Trademark Office received two 

patent term restoration applications for 

INFUSE BONE GRAFT/LT–CAGE 

LUMBAR TAPERED FUSION DEVICE 

(U.S. Patent Nos. 5,782,919 and 

5,984,967)) from SDGI Holdings, Inc., 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining these patents’ eligibility for 

patent term restoration. In a letter dated 

April 6, 2004, FDA advised the Patent 

and Trademark Office that this medical 

device had undergone a regulatory 

review period and that the approval of 

INFUSE BONE GRAFT/LT–CAGE 

LUMBAR TAPERED FUSION DEVICE 

represented the first permitted 


sroberts on PROD1PC70 with NOTICES