64072 Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 

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.

New Animal Drug Application, Form 

356 V—21 CFR Part 514 (OMB Control 

Number 0910–0032)—Extension

FDA has the responsibility under the 

Federal Food, Drug and Cosmetic Act 

(the act), for the approval of new animal 

drugs that are safe and effective. Section 

512(b) of the act (21 U.S.C. 360b(b)) 

requires that a sponsor submit and 

receive approval of a new animal drug 

application (NADA) before interstate 

marketing is allowed. The regulations 

implementing statutory requirements for 

NADA approval have been codified 

under 21 CFR part 514. NADA 

applicants generally use a single form, 

FDA 356 V. The NADA must contain, 

among other things, safety and 

effectiveness data for the drug, labeling, 

a list of components, manufacturing and 

controls information, and complete 

information on any methods used to 

determine residues of drug chemicals in 

edible tissues. While the NADA is 

pending, an amended application may 

be submitted for proposed changes. 

After an NADA has been approved, a 

supplemental application must be 

submitted for certain proposed changes, 

including changes beyond the variations 

provided for in the NADA and other 

labeling changes. An amended 

application and a supplemental 

application may omit statements 

concerning which no change is 

proposed. This information is reviewed 

by FDA scientific personnel to ensure 

that the intended use of an animal drug, 

whether as a pharmaceutical dosage 

form, in drinking water, or in medicated 

feed, is safe and effective. The 

respondents are pharmaceutical firms 

that produce veterinary products and 

commercial feed mills.

In the Federal Register of May 19, 

2004 (69 FR 28930), FDA published a 

60-day notice soliciting comments on 

the collection of information 

requirements. In response to that notice, 

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 

514.1 and 514.6 190 7.39 1,405 211.6 297,298

514.8 190 7.39 1,405 30 42,150

514.11 190 7.39 1,405 1 1,405

558.5(i) 1 1 1.0 5 5

Total 340,858

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

The estimate of the burden hours 

required for reporting are based on FY 

2003 data. The burden estimate includes 

original NADAs, supplemental NADAs 

and amendments to unapproved 

applications.

The burden estimate for obtaining a 

waiver (filing a petition) from labeling 

requirements for certain drugs intended 

for use in animal feed or drinking water 

was derived from data by FDA’s 

Division of Animal Feeds in the Center 

for Veterinary Medicine.

Dated: October 27, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24446 Filed 11–2–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0383]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Recommended Glossary and 

Educational Outreach to Support Use 

of Symbols on Labels and in Labeling 

of In Vitro Diagnostic Devices Intended 

for Professional Use

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Recommended Glossary and 

Educational Outreach to Support Use of 

Symbols on Labels and in Labeling of In 

Vitro Diagnostic Devices Intended for 

Professional Use’’ 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 August 5, 2004 (69 

FR 47448), 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 0910–0553. The 

approval expires on October 31, 2007. A 

copy of the supporting statement for this 

information collection is available on 

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

ohrms/dockets.

Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 64073

Dated: October 27, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24447 Filed 11–2–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0245]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Medicated Feeds

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 December 

2, 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, 

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.

Current Good Manufacturing Practice 

Regulations for Medicated Feeds—21 

CFR Part 225—(OMB Control Number 

0910–0152)—Extension

Under section 501 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 351), FDA has the statutory 

authority to issue current good 

manufacturing practice (cGMP) 

regulations for drugs, including 

medicated feeds. Medicated feeds are 

administered to animals for the 

prevention, cure, mitigation, or 

treatment of disease or growth 

promotion and feed efficiency. Statutory 

requirements for cGMPs have been 

codified under part 225 (21 CFR part 

225). Medicated feeds that are not 

manufactured in accordance with these 

regulations are considered adulterated 

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

Under part 225, a manufacturer is 

required to establish, maintain, and 

retain records for a medicated feed, 

including records to document 

procedures required during 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), 

labels, and product distribution.

This information is needed so FDA 

can monitor drug usage and possible 

misformulation of medicated feeds, to 

investigate violative drug residues in 

products from treated animals and 

investigate product defects when a drug 

is recalled. In addition, FDA will use 

the cGMP criteria in part 225 to 

determine whether or not the systems 

and procedures used by manufacturers 

of medicated feeds are adequate to 

assure that their feeds meet the 

requirements of the act as to safety and 

also meet their claimed identity, 

strength, quality, and purity, as required 

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

A license is required when the 

manufacturer of a medicated feed 

involves the use of a drug or drugs 

which FDA has determined requires 

more control because of the need for a 

withdrawal period before slaughter or 

carcinogenic concerns. Conversely, for 

those medicated feeds for which FDA 

has determined that the drugs used in 

their manufacture need less control, a 

license is not required and the 

recordkeeping requirements are less 

demanding.

In the Federal Register of June 14, 

2004 (69 FR 33040), FDA published a 

60-day notice, soliciting comments on 

the collection of information 

requirements for this clearance. In 

response, no comments were received.

Respondents to this collection of 

information are commercial feed mills 

and mixer-feeders.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED COMMERCIAL FEED MILLS)1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency

per Recordkeeper

Total Annual

Records

Hours per

Recordkeeper Total Hours 

225.42(b)(5) through (b)(8) 1,150 260 299,000 1 299,000

225.58(c) and (d) 1,150 45 51,750 .5 28,875

225.80(b)(2) 1,150 1,600 1,840,000 .12 220,800

225.102(b)(1) 1,150 7,800 8,970,000 .08 717,600

225.110(b)(1) and (b)(2) 1,150 7,800 8,970,000 .015 134,550

225.115(b)(1) and (b)(2) 1,150 5 5,750 .12 690

Total 1,397,825

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