Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 12309 

enforce certain sections of the FD&C Act 

in their own names, but provides that 

States must notify FDA before doing so. 

Section 100.2(d) (21 CFR 100.2(d)) sets 

forth the information that a State must 

provide to FDA in a letter of notification 

when it intends to take enforcement 

action under the FD&C Act against a 

particular food located in the State. The 

information required under § 100.2(d) 

will enable FDA to identify the food 

against which the State intends to take 

action and advise the State whether 

Federal action has been taken against it. 

With certain narrow exceptions, Federal 

enforcement action precludes State 

action under the FD&C Act. 

In the Federal Register of November 

9, 2011 (76 FR 69742), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

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 

100.2(d) ................................................................................ 1 1 1 10 10 

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

The estimated reporting burden for 

§ 100.2(d) is minimal because 

enforcement notifications are seldom 

used by States. During the last 3 years, 

FDA has not received any new 

enforcement notifications; therefore, the 

Agency estimates that one or fewer 

notifications will be submitted 

annually. Although FDA has not 

received any new enforcement 

notifications in the last 3 years, it 

believes these information collection 

provisions should be extended to 

provide for the potential future need of 

a State government to submit 

enforcement notifications informing 

FDA when it intends to take 

enforcement action under the FD&C Act 

against a particular food located in the 

State. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4776 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0558] 

Determination That PHENURONE 

(Phenacemide) Tablet, 500 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 PHENURONE (phenacemide) 

Tablet, 500 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 phenacemide 

tablet, 500 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Howard P. Muller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6234, 

Silver Spring, MD 20993–0002, 301– 

796–3602. 

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 approved 

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. 

PHENURONE (phenacemide) Tablet, 

500 mg, is the subject of NDA 007707, 

held by Abbott Laboratories, and 

initially approved on June 28, 1951. 

PHENURONE is an oral anticonvulsant 

indicated for the treatment of epilepsy. 

In a letter dated May 14, 2003, Abbott 

Laboratories requested withdrawal of 

NDA 007707 for PHENURONE 

(phenacemide) Tablet. In the Federal 

Register of May 5, 2004 (69 FR 25124), 

FDA announced that it was 

withdrawing approval of NDA 007707, 

effective June 4, 2004. 

Schiff & Company submitted a citizen 

petition dated October 16, 2008 (Docket 

No. FDA–2008–P–0558), under 21 CFR 

10.30, requesting that the Agency 

determine whether PHENURONE 

(phenacemide) Tablet, 500 mg, 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 

PHENURONE (phenacemide) Tablet, 

500 mg, was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that 

PHENURONE (phenacemide) tablet, 500 

mg, was withdrawn for reasons of safety 

or effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 


tkelley on DSK3SPTVN1PROD with NOTICES
12310 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

1A ‘‘new drug’’ is defined by the FD&C Act as 

a drug that ‘‘is not generally recognized, among 

experts qualified by scientific training and 

experience to evaluate the safety and effectiveness 

of drugs, as safe and effective for use under the 

conditions prescribed, recommended, or suggested 

in the labeling thereof, except that such a drug not 

so recognized shall not be deemed to be a ‘new 

drug’ if at any time prior to the enactment of this 

Act it was subject to the Food and Drugs Act of June 

30, 1906, as amended, and if at such time its 

labeling contained the same representations 

concerning the conditions of its use * * *.’’ (21 

U.S.C. 321(p)). 

2Section 310.6(b)(1) ((21 CFR 310.6(b)(1)) 

provides: ‘‘An identical, related, or similar drug 

includes other brands, potencies, dosage forms, 

salts, and esters of the same drug moiety as well as 

of any drug moiety related in chemical structure or 

known pharmacological properties.’’ 

PHENURONE (phenacemide) Tablet, 

500 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 PHENURONE 

(phenacemide) Tablet, 500 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 PHENURONE (phenacemide) Tablet, 

500 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: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4783 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1978–N–0441] (formerly 

78N–0324); DESI 10392] 

Drugs for Human Use; Drug Efficacy 

Study Implementation; Prescription 

Drugs That Contained Hydroxyzine 

Hydrochloride or Hydroxyzine 

Pamoate; Final Resolution of Docket 

ACTION: Notice; withdrawal of a hearing 

request. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that all outstanding hearing requests 

pertaining to Docket FDA–1978–N–0441 

(formerly 78N–0324) have been 

withdrawn. Therefore, shipment in 

interstate commerce of any of the 

products identified in that docket, or 

any identical, related, or similar (IRS) 

product that is not the subject of an 

approved new drug application (NDA) 

or abbreviated new drug application 

(ANDA) (other than an over-the-counter 

(OTC) product that complies with an 

applicable OTC monograph), is 

unlawful as of the effective date of this 

notice. 

DATES: Effective Date: This notice is 

effective February 29, 2012. 

ADDRESSES: All communications in 

response to this notice should be 

identified with the docket number 

found in brackets in the heading of this 

document, and directed to Pamela Lee, 

Office of Unapproved Drugs and 

Labeling Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5173, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Pamela Lee, Office of Unapproved Drugs 

and Labeling Compliance, Office of 

Compliance, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5173, Silver Spring, 

MD 20993–0002, 301–796–3297, email: 

pamela.lee@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

When initially enacted in 1938, the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) required that ‘‘new 

drugs’’ be approved for safety by FDA 

before they could legally be sold in 

interstate commerce.1 To this end, the 

FD&C Act made it the sponsor’s 

responsibility, before marketing a new 

drug, to submit an NDA to FDA to prove 

that its drug was safe. Between 1938 and 

1962, if a drug obtained approval, FDA 

considered drugs that were IRS 2 to the 

approved drug to be ‘‘covered’’ by that 

approval, and allowed those IRS drugs 

to be marketed without independent 

approval. 

In 1962, Congress amended the FD&C 

Act to require that new drugs be proven 

effective for their labeled indications, as 

well as safe, to obtain FDA approval. 

This amendment also caused FDA to 

conduct a retrospective evaluation of 

the effectiveness of the drug products 

that FDA had approved as safe between 

1938 and 1962. FDA contracted with the 

National Academy of Sciences/National 

Research Council (NAS/NRC) to make 

an initial evaluation of the effectiveness 

of over 3,400 products that had been 

approved only for safety between 1938 

and 1962. The NAS/NRC reports for 

these drug products were submitted to 

FDA in the late 1960s and early 1970s. 

The Agency reviewed and re-evaluated 

the reports and published its findings in 

Federal Register notices. FDA’s 

administrative implementation of the 

NAS/NRC reports was called the Drug 

Efficacy Study Implementation (DESI). 

DESI covered the approximately 3,400 

products specifically reviewed by the 

NAS/NRC, as well as the even larger 

number of IRS products that entered the 

market without FDA approval. 

All drugs covered by the DESI review 

are ‘‘new drugs’’ under the FD&C Act. 

If FDA’s final DESI determination 

classifies a drug product as lacking 

substantial evidence of effectiveness for 

one or more indications, that drug 

product and those IRS to it may no 

longer be marketed for the indications 

and are subject to enforcement action as 

unapproved new drugs. If FDA’s final 

DESI determination classifies the drug 

product as effective for one or more of 

its labeled indications, the drug can be 

marketed for those indications, 

provided it is the subject of an 

application approved for safety and 

effectiveness. Sponsors of drug products 

that have been found to be effective for 

one or more indications through the 

DESI process may rely on FDA’s 

effectiveness determinations, but 

typically must update their labeling to 

conform to the indication(s) found to be 

effective by FDA and include any 

additional safety information required 

by FDA. Those drug products with 

NDAs approved before 1962 for safety 

therefore require approved supplements 

to their original applications if one or 

more indications are found to be 

effective under DESI; IRS drug products 

require an approved NDA or ANDA, as 

appropriate. Furthermore, labeling for 

drug products classified as effective may 

contain only those indications for which 

the review found the product effective, 

unless the firm marketing the product 

has received an approval for the 

additional indication(s). 

II. Docket No. FDA–1978–N–0441 

(formerly 78N–0324); DESI 10392 

Under Docket No. FDA–1978–N–0441 

(formerly 78N–0324), FDA evaluated the 

evidence of effectiveness for various 

indications for Atarax Tablets (NDA 10– 

392), Atarax Syrup (NDA 10–485), 

Vistaril Injection (NDA 11–111), Vistaril 

Capsules (NDA 11–459), and Vistaril 

Oral Suspension (NDA 11–795), 

products owned by Pfizer, Inc. (Pfizer), 


tkelley on DSK3SPTVN1PROD with NOTICES