27574 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 

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 June 15, 

2007. 

ADDRESSES: 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: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the OMB Control 

Number 0910–NEW and the title 

‘‘Administrative Procedures for the 

Clinical Laboratory Improvement 

Amendments of 1988 Categorization.’’

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (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: 

Administrative Procedures for the 

Clinical Laboratory Improvement 

Amendments of 1988 Categorization (42 

CFR 493.17) 

A draft guidance document entitled 

‘‘Guidance for Administrative 

Procedures for Clinical Laboratory 

Improvement Amendments of 1988 

Categorization’’ (CLIA) was released for 

comment on August 14, 2000. The 

document describes procedures FDA 

will use to assign the complexity 

category to a device. Typically, FDA 

assigns complexity categorizations to 

devices at the time of clearance or 

approval of the device. In this way, no 

additional burden is incurred by the 

manufacturer since the labeling 

(including operating instructions) is 

included in the 510(k) or premarket 

approval (PMA). In some cases, 

however, a manufacturer may request 

CLIA categorization even if FDA is not 

simultaneously reviewing a 510(k) or 

PMA. One example is when a 

manufacturer requests that FDA assign 

CLIA categorization to a previously 

cleared device that has changed names 

since the original CLIA categorization. 

Another example is when a device is 

exempt from premarket review. In such 

cases, the guidance recommends that 

manufacturers provide FDA with a copy 

of the package insert for the device and 

a cover letter indicating why the 

manufacturer is requesting a 

categorization (e.g., name change 

exempt from 510(k) review). The draft 

guidance recommends that in the 

correspondence to FDA the 

manufacturer should identify the 

product code and classification as well 

as reference to the original 510(k) when 

this is available. 

A previous 60-day notice that 

published August 14, 2000 (65 FR 

49582), announced the availability of a 

draft guidance and did not include a 

Paperwork Analysis Section. This 60- 

day notice for public comment 

supersedes that notice and is correcting 

that error. 

In the Federal Register of February 

14, 2007 (72 FR 7043), FDA published 

a 60-day notice soliciting public 

comment on the proposed collection of 

information requirements. In response 

to that notice, no comments were 

received. 

The likely respondents for this 

collection are Investigational New Drug 

Application sponsors. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

42 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total Operating & 

Maintenance 

Costs 

493.17 60 15 900 1 900 $45,000 

Total 60 15 900 1 900 $45,000 

1There are no capital costs associated with this collection of information. 

The number of respondents is 

approximately 60. On average, each 

respondent will request categorizations 

(independent of a 510(k) or PMA) 15 

times per year. The cost, not including 

personnel, is estimated at $50. This 

includes the cost of copying and mailing 

copies of package inserts and a cover 

letter, which includes a statement of the 

reason for the request and reference to 

the original 510(k) numbers, including 

regulation numbers and product codes. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9435 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0494] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Cosmetic Labeling Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Cosmetic Labeling Regulations’’ 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 the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 4, 2006 

(71 FR 70411), 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 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 27575 

OMB control number 0910–0599. The 

approval expires on May 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

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

ohrms/dockets. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9436 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006P–0372] 

Determination That MEPRON 

(Atovaquone) Tablets, 250 milligrams, 

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 MEPRON (atovaquone) tablets, 250 

milligrams (mg), were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

atovaquone tablets, 250 mg. 

FOR FURTHER INFORMATION CONTACT: 

Christine F. Rogers, 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 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 (the 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 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (§ 314.161(a)(1) 

(21 CFR 314.162)). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

MEPRON (atovaquone) tablets, 250 

mg, are the subject of approved NDA 

20–259 held by GlaxoSmithKline 

(Glaxo). MEPRON (atovaquone) tablets, 

250 mg, approved November 25, 1992, 

are indicated for the prevention of 

Pneumocystis carinii pneumonia in 

patients who are intolerant to 

trimethoprim-sulfamethoxazole (TMPSMX). Glaxo ceased marketing 

MEPRON (atovaquone) tablets, 250 mg, 

in 1995. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated 

September 7, 2006 (Docket No. 2006P–

0372/CP1), under 21 CFR 10.30, 

requesting that the agency determine, as 

described in § 314.161, whether 

MEPRON (atovaquone) tablets, 250 mg, 

were withdrawn from sale for reasons of 

safety or effectiveness.The agency has 

determined that Glaxo’s MEPRON 

(atovaquone) tablets, 250 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that MEPRON 

tablets, 250 mg, were withdrawn from 

sale as a result of safety or effectiveness 

concerns. FDA has independently 

evaluated relevant literature and data 

for adverse event reports and has found 

no information that would indicate this 

product was withdrawn for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing its records, FDA 

determines that, for the reasons outlined 

in this notice, Glaxo’s MEPRON 

(atovaquone) tablets, 250 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

agency will list MEPRON (atovaquone) 

tablets, 250 mg, in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety oreffectiveness. 

ANDAs that refer to MEPRON 

(atovaquone) tablets, 250 mg, may be 

approved by the agency as long as they 

meet all relevant legal and regulatory 

requirements for the approval of 

ANDAs. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9348 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0112] 

Guidance for Industry on Clinical Trial 

Endpoints for the Approval of Cancer 

Drugs and Biologics; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Clinical Trial Endpoints for 

the Approval of Cancer Drugs and 

Biologics.’’ This guidance provides 

recommendations to applicants on 

endpoints for cancer clinical trials 

submitted to FDA to support 

effectiveness claims in new drug 

applications, biologics license 

applications, or supplemental 

applications. Applicants are encouraged 

to use this guidance to design cancer 

clinical trials and to discuss protocols 

with the agency. This guidance provides 

background information and discusses 

general regulatory principles. 

Additional companion guidances will 

follow and will focus on endpoints for 

specific cancer types (e.g., lung cancer, 

colon cancer) to support drug approval 

or labeling claims. This guidance, and 

the subsequent indication-specific 

guidances, should speed the 

development and improve the quality of 

protocols submitted to the agency to 

support anticancer effectiveness claims. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 


cprice-sewell on PROD1PC66 with NOTICES