Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 51991 

structure/function claim (65 FR 1000 at 

1046). Therefore, we assume that 

supplement manufacturers will need 

time to assemble the evidence to 

substantiate each of the 2,001 claims 

(2,900 × 69 percent) made each year. If 

we assume that the 2,001 claims are 

equally likely to be pre-existing widely 

established claims, novel claims, or preexisting claims that are not widely 

established, then we can expect 667 of 

each of these types of claims to be 

substantiated per year. Table 1 of this 

document shows that the annual burden 

hours associated with assembling 

evidence for claims is 189,428 (the sum 

of 667 × 44 hours, 667 × 120 hours, and 

667 × 120 hours). 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21236 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–0628] 

Determination That PENTETATE 

CALCIUM TRISODIUM (Trisodium 

Calcium 

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Withdrawn From Sale for Reasons of 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 CALCIUM 

TRISODIUM (trisodium calcium 

diethylenetriaminepentaacetate (CaDTPA)) solution for intravenous or 

inhalation administration, equivalent to 

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

(EQ 200 milligrams (mg) base/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not withdrawn from sale for reasons of 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 

CALCIUM TRISODIUM (Ca-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 (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 CALCIUM TRISODIUM 

(Ca-DTPA) solution for intravenous or 

inhalation administration (EQ 1 g base/ 

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

subject of NDA 21–749, held by Hameln 

Pharmaceuticals GmbH, and initially 

approved on August 11, 2004. 

PENTETATE CALCIUM TRISODIUM 

(Ca-DTPA) 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 

FDA that PENTETATE CALCIUM 

TRISODIUM (Ca-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 November 26, 

2010 (Docket No. FDA–2010–P–0628), 

under 21 CFR 10.30, requesting that the 

Agency determine whether 

PENTETATE CALCIUM TRISODIUM 

(Ca-DTPA) 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 CALCIUM TRISODIUM 

(Ca-DTPA) 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 CALCIUM 

TRISODIUM (Ca-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 CALCIUM TRISODIUM 

(Ca-DTPA) 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 CALCIUM 

TRISODIUM (Ca-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 

CALCIUM TRISODIUM (Ca-DTPA) 

solution for intravenous or inhalation 


jlentini on DSK4TPTVN1PROD with NOTICES
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