Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices 2555 

estimates for this request. The 

availability of the form, and the 

opportunity to provide the information 

in electronic format, could reduce this 

estimate. However, as a conservative 

approach for the purpose of this 

analysis, FDA is assuming that the 

availability of the form and the 

opportunity to submit the information 

in electronic format will have no effect 

on the average time to prepare a GRAS 

notification. 

Dated: January 11, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–783 Filed 1–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–P–0756] 

Determination That PREZISTA 

(darunavir) Tablets, 300 Milligrams 

Was Not Withdrawn From Sale for 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 PREZISTA (darunavir) Tablets, 300 

milligrams (mg), was not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

darunavir tablets, 300 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: Nam 

Kim, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6320, Silver Spring, 

MD 20993–0002, (301) 796–3472. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

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. ANDA applicants 

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 known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed 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 (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

PREZISTA (darunavir) Tablets, 300 

mg, is the subject of NDA 21–976, held 

by Tibotec, Inc., and initially approved 

on June 23, 2006. PREZISTA is a human 

immunodeficiency virus (HIV–1) 

protease inhibitor indicated for the 

treatment of HIV–1 infection in adult 

patients. PREZISTA is also indicated for 

the treatment of HIV–1 infection in 

pediatric patients 6 years of age and 

older. PREZISTA must be 

coadministered with ritonavir 

(PREZISTA/ritonavir) and with other 

antiretroviral agents. 

PREZISTA (darunavir) Tablets, 300 

mg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Lupin Pharmaceuticals, Inc. (Lupin), 

submitted a citizen petition dated 

October 14, 2011 (Docket No. FDA– 

2011–P–0756), under 21 CFR 10.30, 

requesting that the Agency determine 

whether PREZISTA (darunavir) Tablets, 

300 mg, was withdrawn from sale for 

reasons of safety or effectiveness. After 

considering the citizen petition and 

reviewing Agency records and based on 

the information we have at this time, 

FDA has determined under § 314.161 

that PREZISTA (darunavir) Tablets, 300 

mg, was not withdrawn for reasons of 

safety or effectiveness. The petitioner 

Lupin has identified no data or other 

information suggesting that PREZISTA 

(darunavir) Tablets, 300 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

PREZISTA (darunavir) Tablets, 300 mg, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PREZISTA (darunavir) 

Tablets, 300 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 or effectiveness. 

ANDAs that refer to PREZISTA 

(darunavir) Tablets, 300 mg, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: January 11, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–847 Filed 1–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0020 (formerly 

Docket No. 2007D–0249)] 

Guidance for Industry: Preparation of 

Investigational Device Exemptions and 

Investigational New Drug Applications 

for Products Intended To Repair or 

Replace Knee Cartilage; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Preparation of 

IDEs and INDs for Products Intended to 

Repair or Replace Knee Cartilage’’ dated 

December 2011. The guidance 

document provides sponsors of an 

investigational device exemption 

application (IDE) or an investigational 

new drug application (IND) 

recommendations about certain 

information that should be included in 


tkelley on DSK3SPTVN1PROD with NOTICES
2556 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices 

a submission describing a product 

intended to repair or replace knee 

cartilage. The guidance does not apply 

to prostheses such as unicondylar or 

total knee implants, or meniscus 

replacement products. The guidance 

supplements recommendations 

regarding IDE and IND submissions 

contained in other FDA publications. 

The guidance announced in this notice 

finalizes the draft guidance of the same 

title dated July 2007. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448; or the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4613, Silver Spring, 

MD 20993. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The guidance 

may also be obtained by mail by calling 

CBER at 1–(800) 835–4709 or (301) 827– 

1800; or by calling CDRH at 1–(800) 

638–2041 or by faxing a request to 

CDRH at (301) 847–8149. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Lori 

Jo Churchyard, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, (301) 827–6210; or 

Elizabeth L. Frank, Center for Devices 

and Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1407, 

Silver Spring, MD 20993, (301) 796– 

5650. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Preparation of IDEs and INDs 

for Products Intended to Repair or 

Replace Knee Cartilage’’ dated 

December 2011. The guidance 

document provides sponsors of an IDE 

or an IND recommendations about 

certain information that should be 

included in a submission describing a 

product intended to repair or replace 

knee cartilage. The guidance does not 

apply to prostheses such as unicondylar 

or total knee implants, or meniscus 

replacement products. Human cells, 

tissues, and cellular and tissue-based 

products (HCT/P’s) regulated solely 

under section 361 of the Public Health 

Service Act (42 U.S.C. 264) and 21 CFR 

part 1271 are beyond the scope of this 

guidance. A product intended to repair 

or replace knee cartilage may include a 

biologic, device, or combination product 

(comprised of two or more different 

types of regulated constituents) whose 

components would individually be 

regulated by CBER and CDRH. The 

guidance addresses issues that may arise 

in the development of articular cartilage 

repair or replacement products. The 

guidance supplements other FDA 

publications on IDEs and INDs that may 

be relevant to development of these 

products. 

In the Federal Register of July 9, 2007 

(72 FR 37245), FDA announced the 

availability of the draft guidance of the 

same title dated July 2007. FDA 

received numerous comments on the 

draft guidance, and those comments 

were considered as the guidance was 

finalized. In response to comments, 

changes incorporated in the guidance 

included adding new sections and 

clinical study schedules, elaborating on 

nonclinical data considerations, and 

updating the references. In addition, 

organizational and editorial changes 

were made to improve clarity. Some 

terminology was changed to harmonize 

terminology within the Agency and 

does not change the intent of the 

guidance. The guidance also reflects 

input received from the public and the 

Cellular, Tissue, and Gene Therapy 

Advisory Committee meeting held on 

May 15, 2009. The guidance announced 

in this notice finalizes the draft 

guidance dated July 2007. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

The guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 312 have been approved 

under OMB control number 0910–0014; 

and the collections of information in 21 

CFR part 812 have been approved under 

OMB control number 0910–0078. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either: 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/

default.htm, or http:// 

www.regulations.gov. 

Dated: January 11, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–828 Filed 1–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Ethical and Regulatory Challenges in 

the Development of Pediatric Medical 

Countermeasures; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Office of Pediatric Therapeutics, 

is announcing a public workshop 

entitled ‘‘Ethical and Regulatory 

Challenges in the Development of 

Pediatric Medical Countermeasures.’’ 

There is a critical need for pediatric 

research on medical countermeasures to 

ensure that these products are safe and 

effective in the pediatric population. 

The challenges to developing and 

evaluating drugs, biologics, and devices 

for children in the medical 

countermeasure context are complex 


tkelley on DSK3SPTVN1PROD with NOTICES