37396 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

Dated: June 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18402 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0510]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

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: Submit written comments on the

collection of information by August 10,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

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

compliance with section 3507 of the

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 Medicated Feeds (21

CFR Part 225) (OMB Control Number

0910–0152—Reinstatement)

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 cGMP’s 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 ensure 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 that

FDA can monitor drug usage and

possible misformulation of medicated

feeds, to investigate violative drug

residues in products from treated

animals and to 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 ensure

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. The

respondents to this collection of

information are commercial feed mills

and mixer-feeders.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.42(b)(5) through (b)(8) 1,600 24 38,400 0.41 16,000

225.58(c) and (d) 1,600 24 38,400 0.25 9,600

225.80(b)(2) 1,600 24 38,400 0.16 6,400

225.102(b)(1) through (b)(5) 1,600 24 38,400 1.0 38,400

225.110(b)(1) and (b)(2) 1,600 24 38,400 0.25 9,600

225.115(b)(1) and (b)(2) 1,600 24 38,400 0.25 9,600

Total burden hours 89,600

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

2 Commercial feed mills.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.42(b)(5) through (b)(8) 200 3 600 0.16 100

225.58(c) and (d) 200 3 600 0.16 100

225.80(b)(2) 200 3 600 0.083 50

225.102(b)(1) through (b)(5) 200 3 600 0.5 300

225.110(b)(1) and (b)(2) 200 3

225.115(b)(1) and (b)(2) 200 3
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37397

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS)1 2—Continued

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Total burden hours 550

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

2 Mixer-feeders.

3There is no burden because medicated feeds are consumed on site (§ 225.110 Distribution records; § 225.115 Complaint files).

TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.142 13,000 24 316,800 0.41 132,000

225.158 13,000 24 316,800 0.25 79,200

225.180 13,000 24 316,800 0.16 52,800

225.202 13,000 24 316,800 1.5 475,200

Total burden hours 739,200

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

2 Commercial feed mills.

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.142 45,000 3 135,000 0.16 22,500

225.158 45,000 3 135,500 0.16 22,500

225.180 45,000 3 135,500 0.083 11,250

225.202 45,000 3 135,500 0.5 67,500

Total burden hours 123,750

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

2 Mixer-feeders.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

number of recordkeepers, number of

medicated feeds being manufactured,

etc.) is derived from agency records and

experience.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18398 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0452]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; VERLUMATM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

VERLUMATM and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human biological product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human

biological products, the testing phase

begins when the exemption to permit

the clinical investigations of the

biological becomes effective and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the human biological product and

continues until FDA grants permission

to market the biological product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the