69372 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Notices 

Guam 

Agana Power Plant—(PB2004–100066). 

Illinois 

Bordner Manufacturing Company—

(PB2005–100067). 

Northern Mariana Islands, 

Commonwealth of the 

Saipan Capacitors [a/k/a Tanapag 

Village (Saipan)]—(PB2005–100063). 

Ohio 

Gentile Air Force Station (a/k/a USDOD 

Defense Electronics Supply Center)—

(PB2004–107098). 

Tennessee 

Volunteer Army Ammunition Plant—

(PB2005–100065). 

Texas 

Kelly Air Force Base—(PB2004–

106801).

Dated: November 19, 2004. 

Georgi Jones, 

Director, Office of Policy, Planning, and 

Evaluation, National Center for 

Environmental Health, Agency for Toxic 

Substances and Disease Registry.

[FR Doc. 04–26318 Filed 11–26–04; 8:45 am] 

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–05AJ] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call (404) 498–1210 or 

send comments to Sandi Gambescia, 

CDC Assistant Reports Clearance 

Officer, 1600 Clifton Road, MS–E11, 

Atlanta, GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

National Surveillance for Severe 

Adverse Events (Hospitalization or 

Death) Associated with Treatment of 

Latent Tuberculosis Infection (LTBI)—

New—National Center for HIV, STD, 

and TB Prevention (NCHSTP), Centers 

for Disease Control and Prevention 

(CDC). 

The Centers for Disease Control and 

Prevention proposes to collect data for 

the National Surveillance for Severe 

Adverse Events (Hospitalization or 

Death) Associated with Treatment of 

Latent Tuberculosis Infections. CDC is 

requesting OMB approval for three years 

for this proposed data collection. 

As part of the national TB elimination 

strategy, the American Thoracic Society 

and CDC have published 

recommendations for targeted testing for 

TB and treatment for latent TB infection 

(LTBI). However, between October 2000 

and September 2004, the CDC received 

reports of 50 patients with severe 

adverse events associated with the use 

of the two or three-month regimen of 

rifampin and pyrazinamide (RZ) for the 

treatment of LTBI; 12 (24%) patients 

died (Morbidity and Mortality Weekly 

Report 2003;52[31]:735–9). A severe 

adverse event is defined as 

hospitalization or death of a person 

receiving treatment for LTBI. On the 

basis of these data, the American 

Thoracic Society and CDC 

recommended that RZ should generally 

not be offered for treatment of persons 

with LTBI, regardless of HIV status. 

Rifampin and pyrazinamide should 

continue to be administered in 

multidrug regimens for the treatment of 

persons with active TB disease. 

Reports of severe adverse events 

related to RZ and other older LTBI 

regimens have prompted a need for this 

project—a national surveillance system 

of such events. The objective of the 

project is to determine the annual 

number and temporal trends of severe 

adverse events (hospitalization or death) 

associated with any treatment for LTBI 

in the United States. Surveillance of 

such events will provide data to support 

periodic evaluation of guidelines for 

treatment of persons with LTBI and 

revision, as needed.

This project will set up a passive 

reporting system for severe adverse 

events (death or hospitalization) to 

therapy for LTBI. The system will rely 

on medical chart review of already 

existing data by TB control staff. 

Potential respondents are any of the 

60 reporting areas for the national TB 

surveillance system (the 50 states, the 

District of Columbia, New York City, 

and 8 jurisdictions in the Pacific and 

Caribbean). Data will be collected using 

the data collection form for adverse 

events associated with LTBI treatment 

(AELT). Based on previous reporting, 

CDC anticipates receiving an average of 

12 responses per year from the 60 

reporting areas. The AELT form will be 

completed for each reported 

hospitalization or death related to 

treatment of LTBI and contains 

demographic, clinical, and laboratory 

information. CDC will analyze and 

periodically publish reports 

summarizing national LTBI treatment 

adverse events statistics and also will 

conduct special analyses for publication 

in peer-reviewed scientific journals to 

further describe and interpret these 

data. 

The Food and Drug Administration 

(FDA) collects data on adverse events 

related to drugs through the FDA 

MedWatch Program. CDC is planning to 

collaborate with FDA in developing the 

national surveillance system for adverse 

events associated with LTBI. Reporting 

will be conducted through telephone, email, or during CDC site visits. The only 

cost to respondents is their time to 

complete the form.

Respondents Number of

respondents 

Responses 

per

respondent 

Average burden per

response

(in hours) 

Total burden 

(in hours) 

Health Departments ......................................................................................... 12 1 1 12 

Total .......................................................................................................... ........................ ........................ ........................ 12 

Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Notices 69373

Dated: November 19, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–26319 Filed 11–26–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 1997N–0484S]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Eligibility Determination for Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Eligibility Determination for Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps)’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 25, 2004 (69 FR 

29786), 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 0910–0543. The 

approval expires on May 31, 2007. A 

copy of the supporting statement for this 

information collection is available on 

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

ohrms/dockets.

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26235 Filed 11–26–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0204]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Patent Term Restoration, Due 

Diligence Petitions, Filing, Format, and 

Content of Petitions

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Patent Term Restoration, Due Diligence 

Petitions, Filing, Format, and Content of 

Petitions’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 19, 2004 (69 

FR 51468), 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 0910–0233. The 

approval expires on November 30, 2007. 

A copy of the supporting statement for 

this information collection is available 

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

ohrms/dockets.

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26270 Filed 11–26–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P–0141]

Determination That 7.5% and 8.4% 

Sodium Bicarbonate Injection in 

Polyethylene Terephthalate Abboject 

Vials Were Not Withdrawn From Sale 

for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that 7.5% and 8.4% sodium bicarbonate 

injection in polyethylene terephthalate 

(PET) Abboject vials were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for 7.5% and 

8.4% sodium bicarbonate injection.

FOR FURTHER INFORMATION CONTACT:

Nicole Mueller, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an abbreviated new drug 

application (ANDA) procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’

which is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug.

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are withdrawn from the list if the