Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61453 

except where FDA determines that the 

submission and premarket review of a 

food additive petition (FAP) under 

section 409(b) of the act is necessary to 

provide adequate assurance of safety or 

where FDA and the manufacturer or 

supplier agree that an FAP should be 

submitted. Section 409(h)(1) of the act 

requires that a notification include 

information on the identity and the 

intended use of the food contact 

substance and the basis for the 

manufacturer’s or supplier’s 

determination that the food contact 

substance is safe under the intended 

conditions of use. 

Sections 170.101 and 170.106 of 

FDA’s regulations (21 CFR 170.101 and 

170.106) require that a food contact 

notification (FCN) include FDA Form 

3480 entitled ‘‘Notification for New Use 

of a Food Contact Substance’’ and that 

a notification for a food contact 

substance formulation include FDA 

Form 3479 entitled ‘‘Notification for a 

Food Contact Substance Formulation.’’

These forms will serve to summarize 

pertinent information in the 

notification. FDA believes that these 

forms will facilitate both preparation 

and review of notifications because the 

forms will serve to organize information 

necessary to support the safety of the 

use of the food contact substance. The 

burden of filling out the appropriate 

form has been included in the burden 

estimate for the notification. 

Description of Respondents: 

Manufacturers of food contact 

substances. 

In the Federal Register of June 7, 2005 

(70 FR 33180), 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

21 CFR Section No. of Respondents Form Annual Frequency per 

Response 

Total Annual 

Responses Hours per Response Total Hours 

170.1062

(Category A) 

5 FDA 3479 1 5 2 10 

170.1013,7

(Category B) 

5 FDA 3480 1 5 25 125 

170.1014,7

(Category C) 

5 FDA 3480 2 10 120 1,200 

170.1015,7

(Category D) 

33 FDA 3480 2 66 150 9,900 

170.1016,7

(Category E) 

30 FDA 3480 1 30 150 4,500 

Total 15,735 

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

2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of FDA form 3479 

(‘‘Notification for a Food Contact Substance Formulation’’) only. 3 Duplicate notifications for uses of food contact substances. 

4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 

5 Notifications for uses that are the subject of moderately complex food additive petitions. 

6 Notifications for uses that are the subject of very complex food additive petitions. 

7These notifications require the submission of FDA Form 3480. 

These estimates are based on FDA’s 

experience with the food contact 

substances notification system. 

• Based on input from industry 

sources, FDA estimates that the agency 

will receive approximately five 

notifications annually for food contact 

substance formulations. 

• FDA also has included five 

expected duplicate submissions in the 

second row of table 1 of this document. 

FDA expects that the burden for 

preparing these notifications primarily 

will consist of the manufacturer or 

supplier filling out FDA Form 3480, 

verifying that a previous notification is 

effective, and preparing necessary 

documentation. 

• Based on the submissions received, 

FDA identified three other tiers of FCNs 

that represent escalating levels of 

burden required to collect information 

(the third, fourth and fifth rows of table 

1 of this document). 

• FDA estimated the median number 

of hours necessary for collecting 

information for each type of notification 

within each of the three tiers based on 

input from industry sources. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21155 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0396] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution; Appeals Above the 

Division Level 

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 

61454 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

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 contained in 

the guidance for industry on formal 

dispute resolution for appeals above the 

division level. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 23, 2005. 

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: 

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. 

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: (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. 

Guidance for Industry on Formal 

Dispute Resolution; Appeals Above the 

Division Level (OMB Control Number 

0910–0430)—Extension 

This information collection approval 

request is for an FDA guidance on the 

process for formally resolving scientific 

and procedural disputes in the Center 

for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) that 

cannot be resolved at the division level. 

The guidance describes procedures for 

formally appealing such disputes to the 

office or center level and for submitting 

information to assist center officials in 

resolving the issue(s) presented. The 

guidance provides information on how 

the agency will interpret and apply 

provisions of the existing regulations 

regarding internal agency review of 

decisions (21 CFR 10.75), dispute 

resolution during the investigational 

new drug (IND) process (21 CFR 

312.48), and the new drug application/ 

abbreviated new drug application 

(NDA/ANDA) process (21 CFR 314.103). 

In addition, the guidance provides 

information on how the agency will 

interpret and apply the specific 

Prescription Drug User Fee Act 

(PDUFA) goals for major dispute 

resolution associated with the 

development and review of PDUFA 

products. 

Existing regulations, which appear 

primarily in parts 10, 312, and 314 (21 

CFR parts 10, 312, and 314), establish 

procedures for the resolution of 

scientific and procedural disputes 

between interested persons and the 

agency, CDER, and CBER. All agency 

decisions on such matters are based on 

information in the administrative file 

(§ 10.75(d)). In general, the information 

in an administrative file is collected 

under existing regulations in parts 312 

(OMB control number 0910–0014), 314 

(OMB control number 0910–0001), and 

part 601 (21 CFR part 601) (OMB control 

number 0910–0338), which specify the 

information that manufacturers must 

submit so that FDA may properly 

evaluate the safety and effectiveness of 

drugs and biological products. This 

information is usually submitted as part 

of an IND, NDA, or biologics license 

application (BLA), or as a supplement to 

an approved application. While FDA 

already possesses in the administrative 

file the information that would form the 

basis of a decision on a matter in 

dispute resolution, the submission of 

particular information regarding the 

request itself and the data and 

information relied on by the requestor 

in the appeal would facilitate timely 

resolution of the dispute. The guidance 

describes the following collection of 

information not expressly specified 

under existing regulations: The 

submission of the request for dispute 

resolution as an amendment to the 

application for the underlying product, 

including the submission of supporting 

information with the request for dispute 

resolution. 

Agency regulations (§§ 312.23(d), 

314.50, 314.94, and 601.2) state that 

information provided to the agency as 

part of an IND, NDA, ANDA, or BLA is 

to be submitted in triplicate and with an 

appropriate cover form. Form FDA 1571 

must accompany submissions under 

INDs and Form FDA 356h must 

accompany submissions under NDAs, 

ANDAs, and BLAs. Both forms have 

valid OMB control numbers as follows: 

FDA Form 1571, OMB control number 

0910–0014, expires January 31, 2006; 

and FDA Form 356h, OMB control 

number 0910–0338, expires August 31, 

2005. 

In the guidance document, CDER and 

CBER ask that a request for formal 

dispute resolution be submitted as an 

amendment to the application for the 

underlying product and that it be 

submitted to the agency in triplicate 

with the appropriate form attached, 

either Form FDA 1571 or Form FDA 

356h. The agency recommends that a 

request be submitted as an amendment 

in this manner for two reasons: To 

ensure that each request is kept in the 

administrative file with the entire 

underlying application, and to ensure 

that pertinent information about the 

request is entered into the appropriate 

tracking databases. Use of the 

information in the agency’s tracking 

databases enables the appropriate 

agency official to monitor progress on 

the resolution of the dispute and to 

ensure that appropriate steps will be 

taken in a timely manner. 

CDER and CBER have determined, 

and the guidance recommends, that the 

following information should be 

submitted to the appropriate center with 

each request for dispute resolution so 

that the center may quickly and 

efficiently respond to the request: (1) A 

brief but comprehensive statement of 

each issue to be resolved, including a 

description of the issue, the nature of 

the issue (i.e., scientific, procedural, or 

both), possible solutions based on 

information in the administrative file, 

whether informal dispute resolution 

was sought prior to the formal appeal, 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61455 

whether advisory committee review is 

sought, and the expected outcome; (2) a 

statement identifying the review 

division/office that issued the original 

decision on the matter and, if 

applicable, the last agency official that 

attempted to formally resolve the 

matter; (3) a list of documents in the 

administrative file, or additional copies 

of such documents, that are deemed 

necessary for resolution of the issue(s); 

and (4) a statement that the previous 

supervisory level has already had the 

opportunity to review all of the material 

relied on for dispute resolution. The 

agency suggests submitting the 

following information with a formal 

request for dispute resolution: (1) 

Statements describing the issue from the 

perspective of the person with a 

dispute, (2) brief statements describing 

the history of the matter, and (3) the 

documents previously submitted to FDA 

under an OMB approved collection of 

information. 

Based on FDA’s experience with 

dispute resolution, the agency expects 

that most persons seeking formal 

dispute resolution will have gathered 

the materials listed previously when 

identifying the existence of a dispute 

with the agency. Consequently, FDA 

anticipates that the collection of 

information attributed solely to the 

guidance will be minimal. 

Respondents are expected to be 

sponsors, applicants, or manufacturers 

of drug or biological products regulated 

by the agency under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355) or section 351 of the 

Public Health Service Act (42 U.S.C. 

262) who request formal resolution of a 

scientific or procedural dispute. 

Provided below is an estimate of the 

annual reporting burden for requests for 

dispute resolution. Based on data 

collected from review divisions and 

offices within CDER and CBER, FDA 

estimates that approximately eight 

sponsors and applicants (respondents) 

submit requests for formal dispute 

resolution to CDER annually and 

approximately one respondent submits 

requests for formal dispute resolution to 

CBER annually. The total annual 

responses are the total number of 

requests submitted to CDER and CBER 

in 1 year, including requests for dispute 

resolution that a single respondent 

submits more than one time. FDA 

estimates that CDER receives 

approximately 10 requests annually and 

CBER receives approximately 1 request 

annually. The hours per response are 

the estimated number of hours that a 

respondent would spend preparing the 

information to be submitted with a 

request for formal dispute resolution in 

accordance with this guidance, 

including the time it takes to gather and 

copy brief statements describing the 

issue from the perspective of the person 

with the dispute, brief statements 

describing the history of the matter, and 

supporting information that has already 

been submitted to the agency. Based on 

experience, FDA estimates that 

approximately 8 hours on average 

would be needed per response. 

Therefore, FDA estimates that 88 hours 

will be spent per year by respondents 

requesting formal dispute resolution 

under the guidance. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Requests for Formal Dispute 

Resolution 

No. of 

Respondents 

Number of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

CDER 8 1 .25 10 8 80 

CBER 1 1 1 8 8 

Total 88 

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

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21156 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0516] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

2005 Food Safety Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘2005 Food Safety Survey’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 24, 2005 (70 FR 

29768), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0345. The 

approval expires on February 30, 2008. 

A copy of the supporting statement 

for this information collection is 

available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21157 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0216] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices: 

Humanitarian Use Devices 

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