61452 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

alternative ways. A biowaiver may be 

granted if it can be shown that the 

generic soluble powder oral dosage form 

product or Type A medicated article 

contains the same active and inactive 

ingredient(s) and is using the same 

manufacturing processes as the 

approved comparator product or article. 

Alternatively, a biowaiver may be 

granted without direct comparison to 

the pioneer product‘s formulation and 

manufacturing process if it can be 

shown that the active pharmaceutical 

ingredient(s), is the same as the pioneer 

product, is soluble , and that there are 

no ingredients in the formulation likely 

to cause adverse pharmacologic effects. 

For the purpose of evaluating soluble 

powder oral dosage form products and 

Type A medicated articles, solubility 

can be demonstrated in two ways: ‘‘USP 

definition’’ approach or ‘‘Dosage 

Adjusted’’ approach. 

In the Federal Register of August 3, 

2004 (69 FR 46553), the agency 

requested comments on this collection 

of information. In response to that 

notice, the agency received several 

comments on the guidance, two from 

individuals who were generally 

favorable and one from the Animal 

Health Institute (AHI), which was 

supportive of some aspects of the 

proposed guidance and not supportive 

of others. None of the comments 

received took issue with any aspect of 

the paperwork burden associated with 

the draft policy. The Center for 

Veterinary Medicine has revised the 

substance of the proposed guidance in 

several respects in response to AHI 

comments. 

The respondents for this collection of 

information are pharmaceutical 

companies manufacturing animal drugs. 

FDA estimates the burden for this 

collection of information as follows in 

tables 1 and 2 of this document. The 

source of the data is records of generic 

drug applications over the past 10 years. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS1

No. of Respondents Annual Frequency per 

Responses 

Total Annual Responses Hours per Response Total Hours 

Same Formulation / Manufacturing Process Approach 1 1 1 5 5 

Same API / Solubility Approach 5 5 5 10 50 

Total Burden Hours 55 

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

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES1

No. of Respondents Annual Frequency per 

Responses 

Total Annual Responses Hourse per Response Total Hours 

Same Formulation / Manufacturing Process Approach. 2 2 2 5 10 

Same API / Solubility Approach 10 10 10 20 200 

Total Burden Hours 210 

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. 05–21154 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–0209] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; Food 

Contact Substances Notification 

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 November 

23, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

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 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Contact Substances Notification 

System—21 CFR 170.101 and 170.106—

(OMB Control Number 0910–0495)—

Extension 

Section 409(h) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 348(h)) establishes a premarket 

notification process for food contact 

substances. Section 409(h)(6) of the act 

defines a ‘‘food contact substance’’ as 

‘‘any substance intended for use as a 

component of materials used in 

manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food.’’ Section 409(h)(3) of 

the act requires that the notification 

process be used for authorizing the 

marketing of food contact substances 

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