65198 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 

Technological and administrative 

changes necessitate that a new toll-free 

telephone number and a new, more 

sophisticated routing system be 

operational by January 1, 2005. This 

entails collecting administrative 

information from each of the 144 crisis 

centers currently participating in the 

network (e.g., location, hours of 

operation, call capacity, non-English 

language capability) and programming 

the data into a new routing system to 

ensure that each caller is linked to the 

nearest and most appropriate crisis 

center. The form developed to secure 

this information requests only factual 

information that is essential to the 

design of the routing system. 

The following table is the estimated 

hour burden:

Number of respondents Responses/

respondent 

Burden/

response

(hrs.) 

Total

burden 

hours 

144 ........................................................................................................................................................... 1 .17 24.50 

Emergency approval is being 

requested because SAMHSA does not 

want to risk the possibility of disrupting 

the functioning of the national suicide 

prevention hotline network, and the 

subsequent possibility that even one 

individual who tries calling a nonworking hotline might ultimately take 

his/her own life. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within two weeks of this notice 

to: John Kraemer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974.

Dated: November 4, 2004. 

Patricia S. Bransford, 

Acting Executive Officer, SAMHSA.

[FR Doc. 04–25028 Filed 11–9–04; 8:45 am] 

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Request for Application 05017] 

Intervention and Evaluation Trials To 

Prevent Intimate Partner Violence; 

Notice of Availability of FundsAmendment 

A notice announcing the availability 

of fiscal year (FY) 2005 funds for a 

research cooperative agreement program 

to conduct efficacy and effectiveness 

trials of intervention strategies to 

prevent intimate partner violence and/

or its negative consequences, 

particularly studies of strategies that 

have not been well studied, for at-risk 

or underserved populations was 

published in the Federal Register on 

October 27, 2004, Vol. 69, No. 207, 

pages 62694–62701. The notice is 

amended as follows: On page 62696, 

Column 3, Line 2, delete $1,800,000 and 

replace with the new amount of 

$2,250,000.

Dated: November 3, 2004. 

William Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–25027 Filed 11–9–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Public Health Service Act; Delegation 

of Authority 

Notice is hereby given that I have 

delegated to the Director, Centers for 

Disease Control and Prevention (CDC), 

the authority vested in the Secretary of 

Health and Human Services under 

Section 319F–2 of Title III of the Public 

Health Service Act, as amended, to enter 

into agreements with recipients of the 

Stockpile material will be deployed. 

The authority to deploy the Stockpile 

referred to herein is limited to the 

CHEMPACK Program. 

This authority cannot be redelegated. 

Further, CDC must notify the Office of 

Public Health Emergency Preparedness 

before entering into an agreement. 

This delegation became effective upon 

date of signature. In addition, I have 

affirmed and ratified any actions taken 

by the Director, CDC, or his/her 

subordinates which involved the 

exercise of the authorities delegated 

therein prior to the effective date of the 

delegation.

Dated: October 27, 2004. 

Tommy G. Thompson, 

Secretary.

[FR Doc. 04–25002 Filed 11–9–04; 8:45 am] 

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0470]

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; New Animal Drugs 

For Investigational Use

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 reporting and recordkeeping 

requirements for ‘‘New Animal Drugs 

for Investigational Use.’’

DATES: Submit written or electronic 

comments on the collection of 

information by January 10, 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:

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 65199

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 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.

New Animal Drugs for 

Investigational Use—21 CFR Part 511 

(OMB Control Number 0910–0117)—

Extension

FDA has the responsibility under the 

Federal Food, Drug, and Cosmetic Act 

(the act), for approval of new animal 

drugs. Section 512(j) of the act (21 

U.S.C. 360b(j)), authorizes FDA to issue 

regulations relating to the 

investigational use of new animal drugs. 

The regulations setting forth the 

conditions for investigational use of 

new animal drugs have been codified at 

part 511 (21 CFR part 511). A sponsor 

must submit to FDA a Notice of Claimed 

Investigational Exemption (INAD), 

before shipping the new animal drug for 

clinical tests in animals. The INAD must 

contain, among other things, the 

following specific information: (1) 

Identity of the new animal drug, (2) 

labeling, (3) statement of compliance of 

any nonclinical laboratory studies with 

good laboratory practices, (4) name and 

address of each clinical investigator, (5) 

the approximate number of animals to 

be treated or amount of new animal 

drug(s) to be shipped, and (6) 

information regarding the use of edible 

tissues from investigational animals. 

Part 511 also requires that records be 

established and maintained to 

document the distribution and use of 

the investigational drug to assure that its 

use is safe, and that distribution is 

controlled to prevent potential abuse. 

The agency utilizes these required 

records under its Bio-Research 

Monitoring Program to monitor the 

validity of the studies submitted to FDA 

to support new animal drug approval 

and to assure that proper use of the drug 

is maintained by the investigator.

Investigational new animal drugs are 

used primarily by drug industry firms, 

academic institutions, and the 

government. Investigators may include 

individuals from these entities as well 

as research firms and members of the 

medical profession. Respondents to this 

collection of information are the persons 

who use new animal drugs 

investigationally.

FDA estimates the burden for this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents 

Annual Frequency per

Response Total Annual Responses Hours per Response Total Hours 

511.1(b)(4) 190 4.09 778 8 6,224

511.1(b)(5) 190 0.58 110 140 15,400

511.1(b)(6) 190 .01 20 1 20

511.1(b)(8)(ii) 190 .005 1 20 20

511.1(b)(9) 190 .10 20 8 160

Total Burden Hours 21,824

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

ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers 

Annual Frequency per

Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 

511.1(a)(3) 190 2.11 400 9 3,600

511.1(b)(3) 190 4.20 798 1 798

511.1(b)(7)(ii) 400 3.00 1,200 3.5 4,200

511.1(b)(8)(i) 190 6.38 1,200 3.5 4,200

Total Burden Hours 12,798

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

65200 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 

The estimate of the time required for 

reporting requirements, record 

preparation and maintenance for this 

collection of information is based on 

agency communication with industry. 

Additional information needed to make 

a final calculation of the total burden 

hours (i.e. the number of respondents, 

the number of recordkeepers, the 

number of INAD applications received, 

etc.) is derived from agency records.

Dated: November 3, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24991 Filed 11–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N–0481]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Food Additive Petitions

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Food Additive Petitions’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information 

Resources Management (HFA–250), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–1472

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 4, 2004 (69 FR 

31617), 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 0910–0546. The 

approval expires on November 30, 2006. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 3, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24992 Filed 11–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0244]

Agency Information Collection 

Activities: Submission for Office of 

Management and Budget Review; 

Comment Request, Current Good 

Manufacturing Practice Regulations for 

Type A Medicated Articles

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that the proposed collection of 

information listed below has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance under the Paperwork 

Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the 

collection of information by December 

10, 2004.

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 written 

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:

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

4B–41, Rockville, MD 20857, 301–827–

1472.

SUPPLEMENTARY INFORMATION: In 

compliance with section 3507 of the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3507), FDA has submitted the 

following proposed collection of 

information to OMB for review and 

clearance.

Current Good Manufacturing Practice 

Regulations for Type A Medicated 

Articles—21 CFR 226 (OMB Control No. 

0910–0154) Extension

Under section 501 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

351) (the act), FDA has the statutory 

authority to issue current good 

manufacturing practice (cGMP) 

regulations for drugs, including type A 

medicated articles. A type A medicated 

article is a feed product containing a 

concentrated drug diluted with a feed 

carrier substance. A type A medicated 

article is intended solely for use in the 

manufacture of another type A 

medicated article or a type B or type C 

medicated feed. Medicated feeds are 

administered to animals for the 

prevention, cure, mitigation, or 

treatment of disease or for growth 

promotion and feed efficiency. Statutory 

requirements for cGMP‘s for type A 

medicated articles have been codified in 

part 226 (21 CFR part 226). Type A 

medicated articles which are not 

manufactured in accordance with these 

regulations are considered adulterated 

under section 501(a)(2)(B) of the act. 

Under 21 CFR part 226, a manufacturer 

is required to establish, maintain, and 

retain records for Type A medicated 

articles, including records to document 

procedures required under the 

manufacturing process to assure that 

proper quality control is maintained. 

Such records would, for example, 

contain information concerning receipt 

and inventory of drug components, 

batch production, laboratory assay 

results (i.e. batch and stability testing) 

and product distribution. This 

information is needed so that FDA can 

monitor drug usage and possible 

misformulation of type A medicated 

articles. The information could also 

prove useful to FDA in investigating 

product defects when a drug is recalled. 

In addition, FDA will use the cGMP 

criteria in part 226 to determine 

whether or not the systems used by 

manufacturers of Type A medicated 

articles are adequate to assure that their 

medicated articles meet the 

requirements of the act as to safety and 

also meet the articles, claimed identity, 

strength, quality and purity, as required 

by section 501(a)(2)(B) of the act as to 

safety and also meet the articles claimed 

identity, strength, quality, and purity, as 

required by section 501(a)(2)(B) of the 

act.

In the Federal Register of June 4, 2004 

(69 FR 31615), the FDA published a 60-

day notice, soliciting comment on the 

collection of information requirements. 

In response to that notice, no comments 

were received. The respondents for type 

A medicated articles are pharmaceutical 

firms that manufacture both human and 

veterinary drugs, those firms that 

produce only veterinary drugs and 

commercial feed mills.

FDA estimates the burden of this 

collection of information as follows: