46020 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18126 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–M–0208] 

Medical Devices Regulated by the 

Center for Biologics Evaluation and 

Research; Availability of Summaries of 

Safety and Effectiveness Data for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved by the 

Center for Biologics Evaluation and 

Research (CBER). This list is intended to 

inform the public of the availability 

through the Internet and FDA’s Division 

of Dockets Management of summaries of 

safety and effectiveness data of 

approved PMAs. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please include the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness data. 

FOR FURTHER INFORMATION CONTACT: 

Tiffany Brown, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register, 

providing instead to post this 

information on the Internet at http:// 

www.fda.gov. In addition, the 

regulations provide that FDA publish a 

quarterly list of available safety and 

effectiveness summaries of PMA 

approvals and denials that were 

announced during the quarter. FDA 

believes that this procedure expedites 

public notification of these actions 

because announcements can be placed 

on the Internet more quickly than they 

can be published in the Federal 

Register, and FDA believes that the 

Internet is accessible to more people 

than the Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

administrative reconsideration of an 

FDA action under § 10.33(b) (21 CFR 

10.33(b)) for notices announcing 

approval of a PMA begins on the day the 

notice is placed on the Internet. Section 

10.33(b) provides that FDA may, for 

good cause, extend this 30-day period. 

Reconsideration of a denial or 

withdrawal of approval of a PMA may 

be sought only by the applicant; in these 

cases, the 30-day period will begin 

when the applicant is notified by FDA 

in writing of its decision. 

The following is a list of PMAs 

approved by CBER for which summaries 

of safety and effectiveness data were 

placed on the Internet from April 1, 

2008, through June 30, 2008. There were 

no denial actions during this period. 

The list provides the manufacturer’s 

name, the product’s generic name or the 

trade name, and the approval date. 

TABLE 1. LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE APRIL 1, 

2008, THROUGH JUNE 30, 2008 

PMA No./Docket No. Applicant Trade Name Approval Date 

BP050051/0/FDA–2008–M–0208 Ortho-Clinical Diagnostics, 

Inc. 

VITROS Immunodiagnostics Products AntiHIV 1+2 Calibrator, and VITROS 

Immunodiagnostics Products Anti-HIV 

1+2 Reagent Pack 

March 27, 2008 

II.Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cber/products.htm. 

Dated: July 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18125 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0413] 

Draft Guidance for Industry on 

Residual Solvents in Drug Products 

Marketed in the United States; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Control of Residual 

Solvents in Drug Products Marketed in 

the United States.’’ On July 1, 2008, the 

United States Pharmacopeia (USP) 

published a new test requirement for the 

control of residual solvents, General 

Chapter <467> ‘‘Residual Solvents,’’

which replaced USP General Chapter 

<467> ‘‘Organic Volatile Impurities.’’

The change affects all compendial drug 

products marketed in the United States. 

This draft guidance reflects FDA’s 

recommendations on how to comply 

with those USP changes. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 


sroberts on PROD1PC70 with NOTICES