51988 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 

Notifications and Related Issues’’ 

(available at http://www.fda.gov/Food/

GuidanceComplianceRegulatory

Information/GuidanceDocuments/ 

DietarySupplements/ucm257563.htm). 

Some comments argued that FDA 

underestimated the burden of the 

notification procedures under § 190.6 

because it failed to take into account the 

provisions of the new draft guidance. 

(Response) FDA disagrees that we 

underestimated the burden of the 

notification procedures under § 190.6. 

The collection of information analysis 

in the June 3, 2011, notice was limited 

to the sole collection of information 

contained in § 190.6; that is, the 

regulation itself and not the provisions 

of the new draft guidance. The 

notification requirements set forth in 

§ 190.6 remain unchanged. The notice of 

availability for the new draft guidance 

(76 FR 39111, July 5, 2011) states that 

FDA will estimate the paperwork 

burden of the draft guidance document 

and submit it for OMB review under the 

PRA in a future issue of the Federal 

Register. Comments on the new draft 

guidance and any information collection 

provisions therein are outside the scope 

of the comment request in the June 3, 

2011, notice, and will not be discussed 

in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

190.6 .................................................................................... 55 1 55 20 1,100 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

As previously discussed, the Agency 

believes that there will be minimal 

burden on the industry to generate data 

to meet the requirements of the 

premarket notification program because 

the Agency is requesting only that 

information that the manufacturer or 

distributor should already have 

developed as the basis for its conclusion 

that a dietary supplement containing an 

NDI will reasonably be expected to be 

safe. Therefore, the Agency estimates 

that extracting and summarizing the 

relevant information from the 

company’s files, and presenting it in a 

format that will meet the requirements 

of section 413(a) of the FD&C Act and 

§ 190.6 will require a burden of 

approximately 20 hours of work per 

submission. 

The estimated number of premarket 

notifications and hours per response is 

an average based on the Agency’s 

experience with notifications received 

during the last 3 years and information 

from firms that have submitted recent 

premarket notifications. FDA received 

77 notifications in 2008, 39 notifications 

in 2009, and 48 notifications in 2010, 

for an average of 55 notifications. 

Accordingly, we estimate that 55 

respondents will submit 1 premarket 

notification each and that it will take a 

respondent 20 hours to prepare the 

notification, for a total of 1,100 hours. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21237 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–N–0403] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substantiation for 

Dietary Supplement Claims Made 

Under the Federal Food, Drug, and 

Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

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 September 

19, 2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0626. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Substantiation for Dietary Supplement 

Claims Made Under the Federal Food, 

Drug, and Cosmetic Act—21 U.S.C. 

343(r)(6)—(OMB Control Number 0910– 

0626)—Extension 

Section 403(r)(6) of the Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

343(r)(6)) requires that a manufacturer 

of a dietary supplement making a 

nutritional deficiency, structure/ 

function, or general well-being claim 

have substantiation that the statement is 

truthful and not misleading. Under 

section 403(r)(6)(A) of the FD&C Act, 

such a statement is one that ‘‘claims a 

benefit related to a classical nutrient 

deficiency disease and discloses the 

prevalence of such disease in the United 

States, describes the role of a nutrient or 

dietary ingredient intended to affect the 

structure or function in humans, 

characterizes the documented 

mechanism by which a nutrient or 

dietary ingredient acts to maintain such 

structure or function, or describes 

general well-being from consumption 

for a nutrient or dietary ingredient.’’ 

The guidance document entitled 

‘‘Substantiation for Dietary Supplement 

Claims Made Under Section 403(r)(6) of 

the Federal Food, Drug, and Cosmetic 

Act’’ provides FDA’s recommendations 

to manufacturers about the amount, 

type, and quality of evidence they 

should have to substantiate a claim 

under section 403(r)(6) of the FD&C Act. 

The guidance does not discuss the types 

of claims that can be made concerning 


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Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 51989 

the effect of a dietary supplement on the 

structure or function of the body, nor 

does it discuss criteria to determine 

when a statement about a dietary 

supplement is a disease claim. The 

guidance document is intended to assist 

manufacturers in their efforts to comply 

with Section 403(r)(6). Persons with 

access to the Internet may obtain the 

guidance at http://www.cfsan.fda.gov/ 

∼dms/guidance.html. 

Dietary supplement manufacturers 

collect the necessary substantiating 

information for their product as 

required by section 403(r)(6) of the 

FD&C Act. The guidance provides 

information to manufacturers to assist 

them in doing so. The recommendations 

contained in the guidance are voluntary. 

Dietary supplement manufacturers will 

only need to collect information to 

substantiate their product’s nutritional 

deficiency, structure/function, or 

general well-being claim if they choose 

to place a claim on their product’s label. 

The standard discussed in the 

guidance for substantiation of a claim 

on the labeling of a dietary supplement 

is consistent with standards set by the 

Federal Trade Commission for dietary 

supplements and other health-related 

products that the claim be based on 

competent and reliable scientific 

evidence. This evidence standard is 

broad enough that some dietary 

supplement manufacturers may only 

need to collect peer-reviewed scientific 

journal articles to substantiate their 

claims; other dietary supplement 

manufacturers whose products have 

properties that are less well documented 

may have to conduct studies to build a 

body of evidence to support their 

claims. It is unlikely that a dietary 

supplement manufacturer will attempt 

to make a claim when the cost of 

obtaining the evidence to support the 

claim outweighs the benefits of having 

the claim on the product’s label. It is 

likely that manufacturers will seek 

substantiation for their claims in the 

scientific literature. 

The time it takes to assemble the 

necessary scientific information to 

support their claims depends on the 

product and the claimed benefits. If the 

product is one of several on the market 

making a particular claim for which 

there is adequate publicly available and 

widely established evidence supporting 

the claim, then the time to gather 

supporting data will be minimal; if the 

product is the first of its kind to make 

a particular claim or the evidence 

supporting the claim is less publicly 

available or not widely established, then 

gathering the appropriate scientific 

evidence to substantiate the claim will 

be more time consuming. 

In the Federal Register of June 3, 2011 

(76 FR 32215), FDA published a 60-day 

notice requesting public comment on 

the proposed extension of this 

collection of information. FDA received 

five letters in response to the notice, 

each containing multiple comments. 

Several comments were generally 

supportive of the necessity of the 

information collection provisions of the 

guidance. Additional comments were 

outside the scope of the four collection 

of information topics on which the 

notice solicits comments, and will not 

be discussed in this document. 

(Comment 1) Several comment letters 

noted the accuracy of FDA’s estimate of 

the burden hours, which ranges from 44 

to 120 hours per claim depending upon 

the nature of the claim. 

(Response) FDA agrees. As discussed 

in this notice, if the product is one of 

several on the market making a 

particular claim for which there is 

adequate publicly available and widely 

established evidence supporting the 

claim, then the time to gather 

supporting data will be minimal; if the 

product is the first of its kind to make 

a particular claim or the evidence 

supporting the claim is less publicly 

available or not widely established, then 

gathering the appropriate scientific 

evidence to substantiate the claim will 

be more time consuming. 

(Comment 2) One comment stated 

that FDA incorrectly estimated that 

there are no capital costs associated 

with developing information that meets 

the guidance’s recommendations to 

manufacturers about the amount, type, 

and quality of evidence they should 

have to substantiate a claim under 

section 403(r)(6) of the FD&C Act. The 

comment argued that FDA did not fully 

consider that manufacturers invest 

significant capital resources in 

subscriptions to scientific journals and 

libraries to gain access to full-text 

scientific literature, consultants to 

develop appropriate wording for claims, 

and legal review of claims. 

(Response) FDA disagrees. The 

comment mischaracterizes the 

significant costs associated with hiring 

consultants, obtaining reference 

materials, and securing legal review of 

a notification as capital costs. For 

purposes of information collection 

requests under the Paperwork 

Reduction Act, capital costs are costs for 

equipment, machinery, and 

construction that, if not for FDA’s 

request or requirement, the respondent 

would not incur. This includes: Buying 

new software and new computer 

equipment; monitoring, sampling, 

drilling and testing equipment; record 

storage facilities; the cost of purchasing 

or contracting out information 

collection services; and postage costs to 

mail in a report. Capital costs do not 

include costs to achieve regulatory 

compliance with requirements not 

associated with the information 

collection. Subscriptions to scientific 

journals and libraries to gain access to 

full-text scientific literature, hiring 

consultants to develop appropriate 

wording for claims, and legal review of 

claims are costs associated with 

developing information that the 

manufacturer uses to satisfy itself that it 

has met the guidance’s 

recommendations to manufacturers 

about the amount, type, and quality of 

evidence they should have to 

substantiate a claim under section 

403(r)(6) of the FD&C Act; thus, these 

costs are not capital costs because they 

are costs associated with achieving 

regulatory compliance with 

requirements of the FD&C Act, not costs 

associated specifically with equipment, 

machinery, and construction needed to 

retain appropriate substantiating 

evidence. FDA notes that it has added 

a reference to these costs as ‘‘Costs to 

Respondent’’ in section 12(b) of the 

supporting statement component of the 

Information Collection Request that it 

has submitted to OMB. 

(Comment 3) One comment suggested 

that, to enhance the quality, utility and 

clarity of the information as well as 

minimize the burden of collection on 

manufacturers, FDA explore options for 

electronic submission and a digital, 

interactive database so the information 

can be easily reviewed, collated, 

analyzed and reported. 

(Response) FDA notes that dietary 

supplement manufacturers making a 

nutritional deficiency, structure/ 

function, or general well-being claim are 

required by section 403(r)(6) of the 

FD&C Act to have substantiation that 

the claim is truthful and not misleading. 

There is no requirement in the FD&C 

Act or recommendation in the guidance 

document that manufacturers submit 

the substantiation information to FDA. 

The information is retained by the 

manufacturers in their records. The 

guidance does not specifically prescribe 

the use of automated, electronic, 

mechanical, or other technological 

techniques or other forms of information 

technology as necessary for use by 

dietary supplement manufacturers. 

Companies are free to use whatever 

forms of information technology that 

may best assist them in developing 

substantiation information. 

(Comment 4) One comment stated 

that FDA should provide clarity on what 

type of evidence is needed to 

substantiate a traditional use claim. The 


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comment argued that Canada, the 

European Union, and Australia 

recognize traditional use evidence to 

support appropriate claim statements. 

The comment stated that several 

authoritative labeling standards 

monographs for herbal products specify 

traditional use claim statements, such as 

Health Canada Natural Health Products 

Directorate (NHPD) monographs, 

European Medicines Agency (EMA) 

European Community Herbal 

Monographs, and World Health 

Organization (WHO) Monographs on 

Selected Medicinal Plants. The 

comment recommended that FDA allow 

such monographs as acceptable pieces 

of evidence to substantiate a traditional 

use claim. The comment concluded that 

FDA’s acceptance of label claim 

statements listed in appropriate 

monographs and clear guidance on 

other types of evidence that could be 

used to substantiate traditional use 

claims would significantly reduce the 

burden of collecting such information. 

(Response) FDA disagrees that 

traditional use evidence is sufficient to 

meet the substantiation standard of 

competent and reliable scientific 

evidence applied by FDA in ‘‘Guidance 

for Industry: Substantiation for Dietary 

Supplement Claims Made Under 

Section 403(r)(6) of the Federal Food, 

Drug, and Cosmetic Act.’’ A claim based 

on historical or traditional use is not a 

claim that is substantiated by scientific 

evidence. Claims permitted by foreign 

and international monographs do not 

always have to be substantiated by 

scientific studies but may be acceptable 

if, in some cases, they are accompanied 

by disclosures that the claim is not 

scientifically established or are deemed 

appropriate merely by their history of 

use for a particular intended use. 

Therefore, FDA does not believe that 

these monographs are adequate to meet 

the substantiation standard applied by 

FDA. 

(Comment 5) One comment suggested 

that FDA should identify monographs 

that are already recognized in other 

countries as substantiation for claims 

made for products that are 

manufactured in strict conformity to 

these monographs. The comment 

identified two specific compendia of 

monographs and recommended that 

FDA recognize these monographs as 

‘‘constituting in and of themselves 

substantiation for a pre-existing widely 

established claim that may be made for 

a dietary supplement under section 

403(r)(6) of the FD&C Act, so long as the 

claim is not a drug claim and is 

significantly similar to the use or 

purpose described in a monograph, and 

the conditions and level of use of the 

ingredient(s) that is the basis of the 

claim is within the dosage range 

described in the monograph.’’ 

(Response) FDA disagrees that foreign 

or other third-party monographs assure 

that a claim is substantiated by 

competent and reliable scientific 

evidence, which is the standard applied 

by FDA. Claims that may be permitted 

by foreign and international 

monographs do not always have to be 

substantiated by scientific studies but 

may be acceptable if substantiated, in 

whole or in part, by evidence not 

deemed adequate for a claim made for 

a dietary supplement in the United 

States, such as animal data or traditional 

medicinal use. Therefore, FDA does not 

believe that these monographs are 

adequate to meet the substantiation 

standard applied by FDA 

(Comment 6) One comment argued 

that FDA overestimated the burden of 

the information collection by 

overestimating the number of 

respondents. The comment noted that 

FDA’s website contains a list of 

notifications submitted in compliance 

with the requirements of 21 CFR 101.93 

(a)(1) and stated that their review of the 

notices submitted between December 

2007 and August 2010 indicates that the 

Agency has received an average of 

approximately 1,600 to 1,650 annually 

during this time, not the 2,001 per year 

estimated by FDA. 

(Response) FDA disagrees that it has 

overestimated the number of 

respondents and stands by the estimate 

of 2,001 annual respondents for the next 

3 years. The number of such 

notifications received by FDA in any 

given year can vary quite widely (by up 

to 300). In addition, the number of firms 

keeping records in anticipation of 

submitting a notification may be greater 

than the number of notification 

submitted. Thus, FDA believes retaining 

the estimate of 2,001 from the prior 

submission is appropriate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Claim type Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Widely known, established .................................................. 667 1 667 44 29,348 

Pre-existing, not widely established .................................... 667 1 667 120 80,040 

Novel .................................................................................... 667 1 667 120 80,040 

Total .............................................................................. ........................ ........................ ........................ ........................ 189,428 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA assumes that it will take 44 

hours to assemble information needed 

to substantiate a claim on a particular 

dietary supplement when the claim is 

widely known and established. FDA 

believes it will take closer to 120 hours 

to assemble supporting scientific 

information when the claim is novel or 

when the claim is pre-existing but the 

scientific underpinnings of the claim are 

not widely established. These are claims 

that may be based on emerging science, 

where conducting literature searches 

and understanding the literature takes 

time. It is also possible that references 

for claims made for some dietary 

ingredients or dietary supplements may 

primarily be found in foreign journals 

and in foreign languages or in the older, 

classical literature where it is not 

available on computerized literature 

databases or in the major scientific 

reference databases, such as the 

National Library of Medicine’s literature 

database, all of which increases the time 

of obtaining substantiation. 

In the Federal Register of January 6, 

2000, FDA published a final rule on 

statements made for dietary 

supplements concerning the effect of the 

product on the structure or function of 

the body (65 FR 1000). FDA estimated 

that there were 29,000 dietary 

supplement products marketed in the 

United States (65 FR 1000 at 1045). 

Assuming that the flow of new products 

is 10 percent per year, then 2,900 new 

dietary supplement products will come 

on the market each year. The structure/ 

function final rule estimated that about 

69 percent of dietary supplements have 

a claim on their labels, most probably a 


jlentini on DSK4TPTVN1PROD with NOTICES
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