51992 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 

administration (EQ 1 g base/5 mL (EQ 

200 mg base/mL)) 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: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21227 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0630] 

Determination That PENTETATE ZINC 

TRISODIUM (Zinc Trisodium 

Diethylenetriaminepentaacetate) 

Solution for Intravenous or Inhalation 

Administration, Equivalent to 1 Gram 

Base/5 Milliliters (Equivalent to 200 

Milligrams Base/Milliliter), 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Withdrawn From Sale for Reasons of 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 PENTETATE ZINC TRISODIUM 

(zinc trisodium 

diethylenetriaminepentaacetate (ZnDTPA)) solution for intravenous or 

inhalation administration, equivalent to 

(EQ) 1 gram (g) base/5 milliliters (mL) 

(EQ 200 milligrams (mg) base per mL), 

was not withdrawn from sale for reasons 

of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for PENTETATE 

ZINC TRISODIUM (Zn-DTPA) solution 

for intravenous or inhalation 

administration (EQ 1 g base/5 mL (EQ 

200 mg base/mL)), if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Alexis Reisin Miller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6356, 

Silver Spring, MD 20993–0002, 301– 

796–3977. 

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 (the 

FD&C 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. 

PENTETATE ZINC TRISODIUM (ZnDTPA) solution for intravenous or 

inhalation administration (EQ 1 g base/ 

5 mL (EQ 200 mg base/mL)) is the 

subject of NDA 21–751, held by Hameln 

Pharmaceuticals GmbH, and initially 

approved on August 11, 2004. 

PENTETATE ZINC TRISODIUM (ZnDTPA) solution for intravenous or 

inhalation administration (EQ 1 g base/ 

5 mL (EQ 200 mg base/mL)) is indicated 

for treatment of individuals with known 

or suspected internal contamination 

with plutonium, americium, or curium 

to increase the rates of elimination. 

In a letter dated June 24, 2010, 

Hameln Pharmaceuticals GmbH notified 

the FDA that PENTETATE ZINC 

TRISODIUM (Zn-DTPA) solution for 

intravenous or inhalation 

administration (EQ 1 g base/5 mL (EQ 

200 mg base/mL)) was being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Heyl Chemisch-pharmazeutische 

Fabrik GmbH & Co. KG submitted a 

citizen petition dated December 6, 2010 

(Docket No. FDA–2010–P–0630), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

PENTETATE ZINC TRISODIUM (ZnDTPA) solution for intravenous or 

inhalation administration (EQ 1 g base/ 

5 mL (EQ 200 mg base/mL)) was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

PENTETATE ZINC TRISODIUM (ZnDTPA) solution for intravenous or 

inhalation administration (EQ 1 g base/ 

5 mL (EQ 200 mg base/mL)) was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that PENTETATE ZINC 

TRISODIUM (Zn-DTPA) solution for 

intravenous or inhalation 

administration (EQ 1 g base/5 mL (EQ 

200 mg base/mL)) was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

PENTETATE ZINC TRISODIUM (ZnDTPA) solution for intravenous or 

inhalation administration (EQ 1 g base/ 

5 mL (EQ 200 mg base/mL)) 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 PENTETATE ZINC 

TRISODIUM (Zn-DTPA) solution for 

intravenous or inhalation 

administration (EQ 1 g base/5 mL (EQ 

200 mg base/mL)), 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 PENTETATE ZINC 

TRISODIUM (Zn-DTPA) solution for 

intravenous or inhalation 

administration (EQ 1 g base/5 mL (EQ 

200 mg base/mL)) may be approved by 

the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If the FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 51993 

advise ANDA applicants to submit such 

labeling. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21245 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0215] 

Draft Guidance for Industry and Food 

and Drug Administration Staff on In 

Vitro Companion Diagnostic Devices; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

October 12, 2011, the comment period 

for the notice that appeared in the 

Federal Register of July 14, 2011 (76 FR 

41506). In the notice, FDA requested 

comments on a draft guidance 

document entitled ‘‘In Vitro Companion 

Diagnostic Devices.’’ The Agency is 

taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: Submit either written or 

electronic comments by October 12, 

2011. 

ADDRESSES: Submit electronic 

comments on the draft 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. 1601, Rockville, MD 20852. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Mansfield, Center for Devices 

and Radiologic Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 5676, 

Silver Spring, MD 20993–0002, 301– 

796–4664; or 

Christopher Leptak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5102, 

Silver Spring, MD 20993–0002, 301– 

796–0017; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 14, 

2011 (76 FR 41506), FDA published a 

notice announcing the availability of the 

draft guidance entitled ‘‘In Vitro 

Companion Diagnostic Devices,’’ and 

the opening of a public docket to receive 

comments on the draft guidance 

document. Interested persons were 

invited to submit comments by 

September 12, 2011. At this time the 

Agency is extending the comment 

period until October 12, 2011, to 

continue to receive public comments. 

Comments submitted to the docket will 

assist in identifying issues to be 

addressed in the finalized guidance 

document. 

II. Request for 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. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21226 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0586] 

Draft Guidance for Industry on 

Standards for Clinical Trial Imaging 

Endpoints; 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 ‘‘Standards for Clinical 

Trial Imaging Endpoints.’’ The purpose 

of this draft guidance is to assist 

sponsors in the use of imaging 

endpoints in clinical trials of 

therapeutic drugs and biological 

products. The draft guidance describes 

standards sponsors can use to ensure 

that clinical trial imaging data are 

obtained in a manner that complies with 

a trial’s protocol, maintains imaging 

data quality, and provides a verifiable 

record of the imaging process. 

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 

either electronic or written comments 

on the draft guidance by October 18, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft 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: 

Rafel Dwaine Rieves, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 2354, 

Silver Spring, MD 20993 –0002, 301– 

796–2050; or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Standards for Clinical Trial Imaging 

Endpoints.’’ This draft guidance is 

intended to assist sponsors in the 

standardization of imaging procedures 

when an important imaging endpoint is 

used in a clinical trial of a therapeutic 

drug or biological product, especially 

for an efficacy endpoint. As part of the 

reauthorization of the Prescription Drug 

User Fee Act (PDUFA 4), FDA 

committed to certain performance goals 

(see letters from the Secretary of Health 

and Human Services to the Chairman of 


jlentini on DSK4TPTVN1PROD with NOTICES