Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Notices 56707 

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 October 28, 

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 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, 

Rockville, MD 20857, 301–827–1472. 

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. 

Extralabel Drug Use in Animals—21 

CFR Part 530 (OMB Control No. 0910– 

0325)—Extension 

Description: The Animal Medicinal 

Drug Use Clarification Act of 1994 

(AMDUCA) (Public Law 103–396) 

allows a veterinarian to prescribe the 

extralabel use of approved new animal 

drugs. Also, AMDUCA permits FDA, if 

it finds that there is a reasonable 

probability that the extralabel use of an 

animal drug may present a risk to the 

public health, to establish a safe level 

for a residue from the extralabel use of 

an animal drug and to require the 

development of an analytical method for 

the detection of residues above that 

established safe level. Although to date, 

we have not established a safe level for 

a residue from the extralabel use of any 

new animal drug, and therefore have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State or 

Federal government, or individuals. 

In the Federal Register of May 3, 2005 

(70 FR 22884), the agency published a 

60-day notice requesting public 

comment on the collection of 

information. 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 Annual Frequency 

per Response 

Total Annual Responses Hours per Response Total Hours 

530.22(b) 2 1 2 4,160 8,320 

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

The Center for Veterinary Medicine 

(CVM) has not found circumstances to 

require the establishment of a safe level 

and subsequent development of an 

analytical methodology. However, CVM 

believes there will be instances when an 

analytical methodology will be required. 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19392 Filed 9–27–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0210] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Veterinary Feed 

Directive 

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 October 28, 

2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

inlcuding 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, 

Rockville, MD 20857, 301–827–1472. 

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. 

Veterinary Feed Directive—21 CFR Part 

558 (OMB Control Number 0910– 

0363)—Extension 

With the passage of the Animal Drug 

Availability Act (ADAA), Congress 

enacted legislation establishing a new 

class of restricted feed use drugs called 

Veterinary Feed Directive, which can be 

distributed without involving State 

pharmacy laws. Although controls on 

the distribution and use of VFD drugs 

are similar to those for prescription 

drugs regulated under section 503(f) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 353(f)), the implementing 

VFD regulation under 21 CFR 558.6 is 

tailored to the unique circumstances 

relating to the distribution of medicated 

feeds. The content of the VFD is spelled 

out in the regulation. All distributors of 

medicated feeds containing VFD drugs 

must notify FDA of their intent to 

distribute, and records must be 

maintained of the distribution of all 

medicated feeds containing VFD drugs. 

The VFD regulation ensures the 

protection of public health while 

enabling animal producers to obtain and 

use needed drugs as efficiently and costeffectively as possible. 

56708 Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Notices 

In the Federal Register of June 10, 

2005 (70 FR 33907), FDA published a 

60-day notice soliciting comments on 

this collection of information. In 

response to this notice, no comments 

were received. 

The respondents for VFD drugs are 

Veterinarians, distributors of animal 

feeds containing VFD drugs, and clients 

utilizing medicated feeds containing 

VFD drugs. 

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 

558.6(a)(3) through 

558.6(a)(5) 15,000 25 375,000 0.25 93,750 

558.6(d)(1)(i) 

through 

558.6(d)(1)(iii) 1,500 1 500 0.25 125 

558.6(d)(1)(iv) 20 1 20 0.25 5 

558.6(d)(2) 1,000 5 5,000 0.25 1,250 

514.1(b)(9) 1 1 1 3.00 3 

Total Hours 95,133 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR No. of Recordkeepers Annual Frequency per 

Recordkeeper Total Annual Records Hours per Record Total Hours 

558.6(c)(1) through 

558.6(c)(4) 112,500 10 1,125,000 .0167 18,788 

558.6(e)(1) through 

558.6(e)(3) 5,000 75 375,000 .0167 6,263 

Total Hours 25,051 

1There are no capitals cost or operating and maintenance cost associated with this collection of information. 

The estimate of the times required for 

record preparation and maintenance is 

based on agency communication with 

industry. Other information needed to 

calculate the total burden hours are 

derived from agency records and 

experience. 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19393 Filed 9–27–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0208] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Dissemination of 

Information on Unapproved/New Uses 

for Marketed Drugs, Biologics, and 

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 

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 October 28, 

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 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: 

Karen L. Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

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. 

Dissemination of Information on 

Unapproved/New Uses for Marketed 

Drugs, Biologics, and Devices (OMB 

Control Number 0910–0390)—Extension 

In the Federal Register of November 

20, 1998 (63 FR 64556), FDA published 

a final rule that added a new part 99 (21 

CFR part 99) entitled ‘‘Dissemination of 

Information on Unapproved/New Uses 

for Marketed Drugs, Biologics, and 

Devices.’’

The final rule implemented section 

401 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115). 

In brief, section 401 of FDAMA 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 360aaa 

through 360aaa-6) to permit drug, 

biologic, and device manufacturers to 

disseminate certain written information 

concerning the safety, effectiveness, or 

benefits of a use that is not described in 

the product’s approved labeling to 

health care practitioners, pharmacy 

benefit managers, health insurance 

issuers, group health plans, and Federal 

and State Government agencies, 

provided that the manufacturer 

complies with certain statutory 

requirements. For example, the 

information that is to be disseminated 

must be about a drug or device that is 

being marketed legally; it must be in the 

form of an unabridged reprint or copy 

of a peer-reviewed journal article or 

reference publication; and it must not be 

derived from another manufacturer’s 

clinical research, unless that other 

manufacturer has given its permission 

for the dissemination. The information