Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 64071

(CBER’s) database system, there were 90 

licensed biologics manufacturers. This 

number excludes those manufacturers 

who produce blood and blood 

components and in-vitro diagnostic 

licensed products because these 

products are specifically exempt from 

the regulations under § 600.80(k). The 

total annual responses are based on the 

average estimated number of 

submissions received annually by FDA 

for FY 2002 and 2003. However, not all 

manufacturers have submissions in a 

given year and some may have multiple 

submissions. There were an estimated 

15,126 15-day alert reports, 6,550 

periodic reports, and 323 lot 

distribution reports submitted to FDA. 

The number of 15-day alert report for 

postmarketing studies under § 600.80(e) 

is included in the total number of 15-

day alert reports. FDA received an 

average of 5 waiver requests for FY 2002 

and 2003 under § 600.90, all of which 

were approved for exemption of the 

AER requirements. The hours per 

response are based on FDA’s 

experience. The burden hours required 

to complete the MedWatch Form for 

§ 600.80(c)(1), (e), and (f) are reported 

under OMB control number 0910–0291.

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 

600.80(c)(1) and 

600.80(e) 90 168.07 15,126 1 15,126

600.80(c)(2) 90 72.78 6,550 28 183,400

600.81 90 3.59 323 1 355

600.90 5 1 5 1 5

Total 198,886

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

In table 2 of this document, the 

number of respondents is based on the 

number of manufacturers subject to 

those regulations. Based on information 

obtained from CBER’s database system, 

there were 320 licensed manufacturers 

of biological products in FY 2002 and 

2003. However, the number of 

recordkeepers listed for § 600.12(a) 

through (e) excluding paragraph (b)(2) is 

estimated to be 116. This number 

excludes manufacturers of blood and 

blood components because their burden 

hours for recordkeeping have been 

reported under § 606.160 in OMB 

control number 0910–0116. The total 

annual records is based on the annual 

average of lots released (6,630), number 

of recalls made (1,958), and total 

number of AER reports received 

(35,484) in FY 2002 and 2003. The 

hours per record are based on FDA’s 

experience.

FDA estimates the burden of this 

recordkeeping as follows:

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records Hours per Response Total Hours 

600.12 116 57.16 6,630 32 212,160

600.12(b)(2) 320 6.12 1,958 24 46,992

600.80(i) 90 394.27 35,484 1 35,484

Total 294,636

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

Dated: October 27, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24445 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–0179]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Animal Drug 

Application, Form FDA 356 V

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 

(the PRA).

DATES: Fax written comments on the 

collection of information by December 

3, 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 

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.