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.

64074 Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED MIXER-FEEDERS)1

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) 100 260 26,000 .15 3,900

225.58(c) and (d) 100 36 3,600 .5 1,800

225.80(b)(2) 100 48 4,800 .12 576

225.102(b)(1) through (b)(5) 100 260 26,000 .4 10,400

TOTAL 16,676

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

TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED COMMERCIAL FEED MILLS)1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours 

225.142 8,000 4 32,000 1 32,000

225.158 8,000 1 8,000 4 32,000

225.180 8,000 96 768,000 .12 92,160

225.202 8,000 260 2,080,000 .65 1,352,000

TOTAL 1,508,160

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

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER-FEEDERS)1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours 

225.142 45,000 4 180,000 1 180,000

225.158 45,000 1 45,000 4 180,000

225.180 45,000 32 1,440,000 .12 172,000

225.202 45,000 260 11,700,000 .33 3,861,000

TOTAL 4,393,000

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

The estimate of the times required for 

record preparation and maintenance is 

based on agency communications with 

industry. Other information needed to 

finally 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: October 27, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24448 Filed 11–2–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

State-of-the-Science Conference on 

Improving End-of-Life Care

ACTION: Notice.

Notice is hereby given of the National 

Institutes of Health (NIH) ‘‘State-of-theScience Conference on Improving Endof-Life Care’’ to be held December 6–8, 

2004, in the NIH Natcher Conference 

Center, 45 Center Drive, Bethesda, 

Maryland 20892. The conference will 

begin at 8:30 a.m. on December 6 and 

7, and at 9 a.m. on December 8, and will 

be open to the public. 

Improvements in medical science and 

health care have gradually changed the 

nature of dying. Death is no longer as 

likely to be the sudden result of 

infection or injury but is now more 

likely to occur slowly, in old age, and 

at the end of a period of chronic illness. 

As a result, a demographic shift is 

beginning to occur that will include an 

increase in the number of seriously ill 

and dying people at the same time that 

the number of caregivers decreases. To 

meet this challenge, the best that 

science can offer must be applied to 

guarantee the quality of care provided to 

the dying. 

The 1997 publication of the Institute 

of Medicine report ‘‘Approaching Death: 

Improving Care at the End of Life’’

triggered a series of activities to improve