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