Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73599 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Number of 

nonrespondents 

Number of 

responses 

per nonrespondent 

Total annual 

nonresponses 

Average 

burden per 

response 

Total hours 

2017–2018 Data Collection (Fast Food Restaurants)—Completion of Sections 1 and 

3.

400 1 400 1.36 ........... 544 

2017–2018 Data Collection (Full Service 

Restaurants)—Completion of Sections 1 

and 3.

400 1 400 1.73 ........... 692 

2017–2018 Data Collection-Completion of 

Section 2—All Facility 

Types.

800 1 800 0.5 (30 minutes).400 

2017–2018 Data Collection-Entry Refusals— 

All Facility Types.

16 1 16 0.08 (5 minutes).1.28 

Total hours ............ ............... 1,637.28 

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

II. Reference 

The following reference has 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, and are available 

electronically at http://

www.regulations.gov. 

1. FDA Food Code. Available at: 

http://www.fda.gov/Food/

GuidanceRegulation/

RetailFoodProtection/FoodCode/

default.htm. 

Dated: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29065 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0320] 

Determination That PFIZERPEN 

(Penicillin G Potassium) Injection, 1 

Million Units/Vial, Was Not Withdrawn 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 PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for penicillin G 

potassium injection, 1 million units/

vial, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6250, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

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 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 (21 CFR 314.161). FDA may 

not approve an ANDA that does not 

refer to a listed drug. 

PFIZERPEN (penicillin G potassium) 

Injection, 1 million units/vial, is the 

subject of ANDA 60–657, held by Pfizer, 

Inc., and initially approved on August 

30, 1968. ANDA 60–657 is considered 

the designated reference standard. 

PFIZERPEN is indicated in the 

treatment of serious infections caused 

by susceptible strains of the designated 

microorganisms in certain conditions 

such as septicemia, pneumonia, 

meningitis, anthrax, and listeria. 

PFIZERPEN (penicillin G potassium) 

Injection, 1 million units/vial, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. Lachman Consultant Services, 

Inc., submitted a citizen petition dated 

May 27, 2008 (Docket No. FDA–2008– 

P–0320), under 21 CFR 10.30, 

mstockstill on DSK4VPTVN1PROD with NOTICES

73600 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

requesting that the Agency determine 

whether PFIZERPEN (penicillin G 

potassium) Injection, 1 units/vial, and 

penicillin G potassium injection, 1 

million units/vial, had been withdrawn 

from sale for reasons of safety or 

effectiveness. Penicillin G potassium 

Injection, 1 million units/vial, is the 

subject of ANDA 65–079, held by 

Sandoz, and approved on August 30, 

2002. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, was not withdrawn for reasons of 

safety or effectiveness (this 

determination also applies to penicillin 

G potassium injection, 1 million units/ 

vial, ANDA 65–079). The petitioner 

believes that PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, was not withdrawn for reasons of 

safety or effectiveness because it was 

discontinued due to commercial 

reasons. We have carefully reviewed our 

files for records concerning the 

withdrawal of PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this product was not 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PFIZERPEN (penicillin 

G potassium) Injection, 1 million units/ 

vial, 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 PFIZERPEN (penicillin G potassium) 

Injection, 1 million units/vial, 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: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29034 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Bioequivalence Recommendations for 

Budesonide Extended-Release 

Tablets; Draft Guidance for Industry; 

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 ‘‘Bioequivalence 

Recommendations for Budesonide 

Extended-Release Tablets.’’ The 

guidance provides specific 

recommendations on the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for budesonide extendedrelease tablets. 

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 comments 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 February 9, 

2015. 

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. Send 

one self-addressed adhesive label to 

assist that 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: Kris 

Andre ́, Center for Drug Evaluation and 

Research (HFD–600), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1615, Silver Spring, 

MD 20993–0002, 240–402–7290. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm. As described in 

that guidance, FDA adopted this process 

as a means to develop and disseminate 

product-specific BE recommendations 

and to provide a meaningful 

opportunity for the public to consider 

and comment on those 

recommendations. This notice 

announces the availability of draft BE 

recommendations for budesonide 

extended-release tablets. 

New drug application 203634 for 

UCERIS (budesonide) extended-release 

tablets, 9 milligrams (mg), was initially 

approved by FDA in January 2013. FDA 

is now issuing a draft guidance for 

industry on BE recommendations for 

generic budesonide extended-release 

tablets. 

In February 2013, Santarus, Inc., 

submitted a citizen petition requesting 

that FDA: (1) Issue an individual BE 

guidance for budesonide extendedrelease tablets and (2) refrain from 

approving any ANDA that identifies 

UCERIS (budesonide) extended-release 

tablets as the reference listed drug 

unless the generic product is shown to 

be bioequivalent based on appropriate 

data from a clinical efficacy endpoint 

study, comparative pharmacokinetic 

testing, in vitro dissolution testing, and 

pharmacoscintigraphy studies (Docket 

No. FDA 2013–P–0127). FDA reviewed 

the issues raised in the petition and is 

responding to the petition today in a 

letter that will be included in the citizen 

petition docket. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for budesonide extended-release 

tablets. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

mstockstill on DSK4VPTVN1PROD with NOTICES