12308 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

ability to correct misinformation is 

related to (a) corrective ad similarity to 

the original ad and (b) time delay 

between original ad and corrective ad 

exposure. 

We will vary these two characteristics 

to create a study with a 4x3 

experimental design (see table 2). 

TABLE 2—DESIGN OF PHASE 2: AD SIMILARITY BY EXPOSURE DELAY

Corrective ad similarity 

Exposure delay 

None 1 Week 1 Month 

Same ad elements ......................................................................................................................................................

Some similar elements ................................................................................................................................................

Different ad elements ..................................................................................................................................................

Control (Do not see corrective) ...................................................................................................................................

Prior to conducting the main study, 

we will pretest the stimuli, 

questionnaires, and data collection 

process. The first set of pretests will 

focus on the stimuli, and its purpose 

will be to (a) ensure the stimuli display 

properly, (b) ensure participants 

perceive the stimuli as realistic, and (c) 

ensure participants notice the original 

and corrective messages in the ads. The 

second pretest will focus on the 

questionnaires and data collection 

process. Its purpose will be to (a) ensure 

that survey questions solicit responses 

that meet the study’s analytic goals and 

(b) ensure data are captured and stored 

accurately for each question. 

FDA estimates the burden of this 

collection of information as follows: 30 

minutes in the pretests and each phase 

of the study, for a burden of 3,092 

hours. This will be a one time (rather 

than annual) collection of information. 

The questionnaire is available upon 

request. 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity No. of respondents 

No. of responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Pretests ............................................. 1,250 1 1,250 0.5 (30 minutes) ............................... 625 

Phase 1 Screener ............................. 3,228 1 3,228 0.033 (2 minutes) ............................. 108 

Phase 1 ............................................. 1,000 1 1,000 0.5 (30 minutes) ............................... 500 

Phase 2 Screener ............................. 10,768 1 10,768 0.033 (2 minutes) ............................. 359 

Phase 2 ............................................. 3,000 1 3,000 0.5 (30 minutes) ............................... 1,500 

Total ........................................... 19,246 ........................ ........................ ........................................................... 3,092 

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

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Darke, P.R., L. Ashworth, and R.J.B. 

Ritchie, ‘‘Damage From Corrective 

Advertising: Causes and Cures,’’ Journal of 

Marketing, vol. 72, pp. 81–97, 2008. 

2. Mazis, M.B. and J.E. Adkinson, ‘‘An 

Experimental Evaluation of a Proposed 

Corrective Advertising Remedy,’’ Journal of 

Marketing Research, vol. 13, pp. 178–183, 

1976. 

3. Mazis, M.B., D.L. McNeill, and K.L. 

Bernhardt, ‘‘Day-After Recall of Listerine 

Corrective Commercials,’’ Journal of Public 

Policy & Marketing, vol. 2, pp. 29–37, 1983. 

4. Singer, N., A Birth Control Pill That 

Promised Too Much, New York Times, 

February 11, 2009, p. B1. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4777 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–2011–N–0797] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Enforcement 

Notifications 

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 March 30, 

2012. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0275. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, II, 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. 

State Enforcement Notifications—21 

CFR 100.2(d) (OMB Control Number 

0910–0275)—Extension 

Section 310(b) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 337(b)) authorizes States to 


tkelley on DSK3SPTVN1PROD with NOTICES
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