Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22529 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–P–1896] 

Determination That OXYTOCIN in 5% 

Dextrose Injection Products Were 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Withdrawn From Sale for Reasons of 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 or Agency) has 

determined that OXYTOCIN 5 United 

States Pharmacopeia (USP) Units in 

Dextrose 5% (oxytocin), injectable, 

injection, 5 USP Units in 500 milliliters 

(mL), (1 USP Unit/100 mL); OXYTOCIN 

10 USP Units in Dextrose 5% 

(oxytocin), injectable, injection, 10 USP 

Units in 500 mL, (2 USP Units/100 mL); 

OXYTOCIN 10 USP Units in Dextrose 

5% (oxytocin), injectable, injection, 10 

USP Units in 1000 mL, (1 USP Unit/100 

mL); and OXYTOCIN 20 USP Units in 

Dextrose 5% (oxytocin), injectable, 

injection, 20 USP Units in 1000 mL, (2 

USP Units/100 mL), (hereinafter ‘‘these 

oxytocin drug products’’) were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve an abbreviated new drug 

application (ANDA) for these oxytocin 

drug products, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Robin Fastenau, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6236, 

Silver Spring, MD 20993–0002, 240– 

402–4510. 

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 (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

These oxytocin drug products are the 

subject of NDA 019–185, held by Abbott 

Laboratories, and initially approved on 

March 29, 1985. These oxytocin drug 

products are indicated for the initiation 

or improvement of uterine contractions. 

In a December 26, 1995, letter, Abbott 

Laboratories notified FDA that these 

oxytocin drug products were being 

discontinued and requested withdrawal 

of NDA 019–185. In the Federal 

Register of March 27, 1996 (61 FR 

13506), FDA announced that it was 

withdrawing approval of NDA 019–185, 

effective April 26, 1996. FDA has moved 

these oxytocin drug products to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

TechReg Services, Inc. (TechReg), 

submitted a citizen petition dated 

November 12, 2014 (Docket No. FDA– 

2014–P–1896), under 21 CFR 10.30, 

requesting that the Agency determine 

whether Oxytocin in Dextrose 5%, 

injection, available as strengths 5, 10, 

and 20 units under Abbott NDA 019– 

185, were withdrawn from sale for 

reasons of safety or effectiveness. 

Although the citizen petition did not 

specify the concentrations of the three 

strengths associated with NDA 019–185, 

we have considered whether any of 

these oxytocin drug products approved 

under NDA 019–185 were withdrawn 

for safety or effectiveness reasons. 

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 these oxytocin drug 

products were not withdrawn for 

reasons of safety or effectiveness. 

TechReg has identified no data or other 

information suggesting that these 

oxytocin drug products were withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

these oxytocin drug products 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 these oxytocin drug 

products were withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list these oxytocin drug 

products 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 these oxytocin drug 

products may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. FDA has 

determined that labeling for these 

oxytocin drug products should be 

revised to meet current standards and 

will advise ANDA applicants how to 

submit such labeling. 

Dated: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09299 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–1163] 

Providing Regulatory Submissions in 

Electronic and Non-Electronic 

Format—Promotional Labeling and 

Advertising Materials for Human 

Prescription Drugs, 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 ‘‘Providing Regulatory 

Submissions in Electronic and NonElectronic Format—Promotional 

Labeling and Advertising Materials for 

Human Prescription Drugs.’’ This draft 

guidance explains how manufacturers, 

packers, and distributors (firms) that 

may either be the applicant or acting on 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
22530 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 

1The draft guidance for industry is available on 

the FDA eCTD Web page at http://www.fda.gov/

downloads/Drugs/

GuidanceComplianceRegulatoryInformation/

Guidances/UCM333969.pdf. 

2The specification for industry is available on the 

FDA eCTD Module 1 Web page at http://

www.fda.gov/Drugs/DevelopmentApprovalProcess/

FormsSubmissionRequirements/

ElectronicSubmissions/ucm253101.htm. 

behalf of the applicant, should make 

submissions pertaining to promotional 

materials for human prescription drugs 

and biologic products (‘‘drugs’’) to the 

Office of Prescription Drug Promotion 

(OPDP) in the Center for Drug 

Evaluation and Research (CDER) and the 

Advertising and Promotional Labeling 

Branch (APLB) in the Center for 

Biologics Evaluation and Research 

(CBER). This draft guidance describes 

the various types of submissions of 

promotional materials and general 

considerations for submissions. In 

addition, this draft guidance discusses 

the specific aspects of submission of 

promotional materials using module 1 

of the electronic Common Technical 

Document (eCTD) using version 3.3 or 

higher of the us-regional-backbone file. 

This guidance does not address the 

more general requirements for a valid 

electronic submission using eCTD or the 

specifications for module 1 of the eCTD. 

This guidance contains both binding 

and nonbinding provisions. 

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 July 21, 2015. 

Submit either electronic or written 

comments on the proposed collection of 

information by June 22, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communications, Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993–0002; or 

to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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 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. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding human prescription drugs: 

Marci Kiester, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3368, 

Silver Spring, MD 20993–0002, 301– 

796–1200. 

Regarding prescription human 

biological products: Stephen Ripley, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic and Non-Electronic Format— 

Promotional Labeling and Advertising 

Materials for Human Prescription 

Drugs.’’ This draft guidance is intended 

to be used in conjunction with the draft 

guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Certain Human Pharmaceutical 

Product Applications and Related 

Submissions Using the eCTD 

Specifications’’ 1 (eCTD Revised Draft 

Guidance) and in conjunction with the 

specification to industry ‘‘The eCTD 

Backbone Files Specification for Module 

1 Version 2.3.’’ 2

This draft guidance describes various 

types of regulatory submissions of 

promotional materials that firms submit 

to CDER and CBER and general 

considerations for such submissions. 

For example, the draft guidance 

describes the various types of voluntary 

submissions (e.g., launch and nonlaunch voluntary submissions of draft 

promotional materials for advisory 

comments) and required submissions of 

promotional labeling and advertising 

materials (e.g., fulfillment of the 

regulatory requirements for 

postmarketing submissions of 

promotional materials and submission 

of promotional materials for accelerated 

approval products). In addition, this 

draft guidance discusses specific aspects 

of the content and format for submitting 

promotional materials in paper hard 

copy and electronic format, including 

how to submit promotional materials 

electronically in module 1 of the eCTD 

using version 3.3 or higher of the usregional-backbone file. This draft 

guidance provides recommendations for 

what to include with each type of 

submission and the number of copies to 

include if it is a paper submission. This 

draft guidance provides 

recommendations for presentation 

considerations such as appearance, 

layout, format, and visible impression of 

promotional materials submitted for all 

promotional submission types. 

This draft guidance also provides 

instructions on how to submit 

promotional labeling and advertising 

materials to FDA electronically in eCTD 

format. It explains that for submissions 

of promotional materials that fall within 

the ambit of section 745A(a) of the 

FD&C Act, as amended by section 1136 

of the Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

144), such submissions must be made in 

the electronic format specified by FDA 

in this guidance and the eCTD Revised 

Draft Guidance, beginning no earlier 

than 24 months after this guidance is 

finalized. Specifically, (1) postmarketing 

submissions of promotional materials 

using Form FDA 2253 (required by 21 

CFR 314.81(b)(3)(i) and 21 CFR 

601.12(f)(4), and (2) submissions of 

promotional materials for accelerated 

approval products (required by FD&C 

Act section 506(c)(2)(B) (21 U.S.C. 

356(c)(2)(B)), and §§ 314.550 and 

601.45) and other products where such 

submissions are required for approval, 

fall within the scope of section 745A(a) 

and are, therefore, subject to the 

mandatory electronic submission 

requirement. When the mandatory 

electronic submission requirement takes 

effect for these types of submissions, 

they will only be accepted by CDER in 

eCTD format using version 3.3 or higher 

of the us-regional-backbone file. CBER 

will be able to accept eCTD submissions 

using previous versions of the usregional-backbone file until 24 months 

after publication of the final version of 

this guidance. The draft guidance also 

provides that, while only promotional 

submissions that fall under section 

745A(a) will be required to be submitted 

electronically no sooner than 24 months 

after this guidance is finalized, firms 

may choose—and are strongly 

encouraged—to submit electronically 

the other types of promotional 

submissions discussed in this guidance. 

This draft guidance is being issued 

under section 745A(a) of the FD&C Act, 

which explicitly authorizes FDA to 

implement the statutory electronic 

submission requirement for certain 

types of submissions by specifying the 

format for such submissions in 

guidance. Accordingly, to the extent 

that the draft guidance provides such 

requirements under section 745A(a), it 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22531 

is not subject to the usual restrictions in 

FDA’s good guidance practices 

regulation (21 CFR 10.115). However, to 

the extent that the draft guidance 

includes provisions regarding 

submission of promotional materials 

that do not pertain to the electronic 

format requirements for submissions 

under section 745A(a), it will represent 

the Agency’s current thinking on the 

submission of promotional materials 

and will not create or confer any rights 

for or on any person or bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3520), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Providing Regulatory 

Submissions in Electronic and NonElectronic Format—Promotional 

Labeling and Advertising Materials for 

Human Prescription Drugs. 

Description of Respondents: 

Respondents to this collection of 

information are firms who make 

regulatory submissions pertaining to 

promotional materials for human 

prescription drug and biologic products 

to OPDP and APLB. 

Burden Estimate: The draft guidance 

pertains to regulatory submissions of 

promotional materials. The draft 

guidance describes the types of 

submissions of promotional materials, 

general considerations for submissions, 

and certain considerations for how to 

submit promotional materials 

electronically and in hard copy. 

The draft guidance includes 

recommendations for when sponsors 

make submissions to OPDP or APLB. 

These recommendations include the 

types of documents that generally 

should be included (e.g., 

correspondence describing the type of 

submission) for promotional labeling 

submitted for advisory comments, 

resubmissions, general correspondence, 

amendments, withdrawal requests, 

responses to untitled letters or warning 

letters, responses to information 

requests, reference documents, and 

complaints. 

For promotional labeling submitted 

for advisory comments, including 

resubmissions, a submission generally 

includes correspondence stating that it 

is a request for advisory comments, a 

clean version of the draft promotional 

materials, an annotated copy of the 

promotional materials, and the most 

current FDA-approved prescribing 

information (PI); if applicable, a 

submission also includes the FDAapproved patient labeling or Medication 

Guide with annotations cross-referenced 

to the proposed promotional materials 

and annotated references to support 

product and disease or epidemiology 

claims not contained in the PI crossreferenced to the promotional material. 

Amendments should be submitted if the 

previous submission to FDA is missing 

one or more promotional materials. 

Amendments should include 

correspondence stating it is an 

amendment and include the 

accompanying materials that were 

previously missing, an annotated copy 

of the promotional materials that were 

omitted from a previous submission to 

FDA, the FDA-approved patient labeling 

or Medication Guide with annotations 

cross-referenced to the proposed 

promotional materials, and annotated 

references to support product and 

disease or epidemiology claims not 

contained in the PI cross-referenced to 

the promotional material. 

General correspondence submissions 

and submissions requesting to withdraw 

a previous submission to FDA include 

correspondence stating the purpose of 

the submission. 

Responses to untitled or warning 

letter submissions include 

correspondence stating that it is a 

response to an untitled or warning 

letter, and include the firm’s initial or 

subsequent responses and the corrective 

piece(s), if applicable. 

Responses to information request 

submissions include the firm’s response 

to the questions and issues raised in 

FDA’s letter of inquiry, including any 

materials that FDA has requested. 

Reference document submissions 

include correspondence stating that it is 

a reference document submission and 

the specific information regarding what 

is in the submission along with the 

annotated references, annotated 

promotional materials, and/or annotated 

labeling. 

Promotional labeling submitted for 

advisory comments, including 

resubmissions and amendments; general 

correspondence; requests to withdraw a 

previous submission; responses to 

untitled or warning letters; responses to 

information requests; and reference 

documents can be submitted in paper or 

electronic form, and the burden 

estimates for these submissions in table 

1 apply to both paper and electronic 

form. 

Complaints include correspondence 

stating that it is a complaint and 

supporting information or 

documentation, if available. Complaints 

are not accepted in electronic form and 

should be submitted as paper hard 

copies. The burden estimate for 

complaints in table 1 thus applies to 

paper hard copies only. 

The draft guidance also describes the 

number of paper hard copies that 

should be sent to OPDP and APLB for 

each submission type (if applicable). 

FDA estimates the burden of this 

collection of information as follows: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
22532 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Type of submission Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Promotional labeling submitted for advisory comments, 

including resubmissions and amendments .................... 199 2 .5 499 50 24,950 

General correspondence submitted to FDA ...................... 200 2 .5 500 2 1,000 

Requests to withdraw a previous submission to FDA ....... 6 1 6 2 12 

Responses to untitled or warning letters ........................... 26 2 52 12 624 

Responses to information requests ................................... 4 1 .5 6 12 72 

Reference documents ........................................................ 7 1 7 12 84 

Complaints submitted to OPDP ......................................... 60 1 60 12 720 

Total ............................................................................ ........................ .......................... ........................ ........................ 27,462 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations 

and collections of information that are 

currently under OMB review. The 

collections of information in 21 CFR 

202.1, including requests for advisory 

comments, resubmissions, and 

amendments for advertisements, have 

been approved under OMB control 

number 0910–0686; the collections of 

information in 21 CFR 601.45 

(presubmission of promotional materials 

for accelerated approval products under 

part 601) have been approved under 

OMB control number 0910–0338; the 

collections of information for FDA Form 

2253 and the presubmission of 

promotional materials for accelerated 

approval products under part 314 have 

been approved under OMB control 

number 0910–0001. FDA has also 

published in the Federal Register a 60- 

day notice soliciting public comments 

on the collections of information that 

result from the submission of television 

advertisements under section 503C of 

the FD&C Act (21 U.S.C. 353c) (77 FR 

14811, March 13, 2012). These burden 

estimates do not change as a result of 

this guidance. This is because new 

burdens for establishing the means for 

submitting materials in electronic form 

to comply with this guidance would be 

negated by the savings in burden from 

not having to print out the materials and 

mail them to FDA. 

Some firms may incur costs 

associated with upgrading technology or 

changing the method of submitting 

information to FDA, and these have 

been described in the Federal Register 

notice for the revised draft guidance for 

industry entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Certain Human Pharmaceutical Product 

Applications and Related Submissions 

Using the Electronic Common Technical 

Document Specifications’’ (79 FR 43494, 

July 25, 2014). 

III. 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 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. 

Dated: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09297 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0093] 

Interim Assessment of the Program for 

Enhanced Review Transparency and 

Communication; Public Meeting and 

Establishment of Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting and 

establishment of docket; request for 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

establishment of a docket to obtain 

comments on the interim assessment of 

the Program for Enhanced Review 

Transparency and Communication for 

New Molecular Entity (NME) New Drug 

Applications (NDAs) and Original 

Biologics License Applications (BLAs) 

(the Program). FDA is also announcing 

a public meeting where the interim 

assessment will be discussed and public 

stakeholders may present their views on 

the Program to date. 

The Program is part of the FDA 

performance commitments under the 

fifth authorization of the Prescription 

Drug User Fee Act (PDUFA), which 

enables FDA to collect user fees for the 

review of human drug and biologics 

applications for fiscal years (FYs) 2013– 

2017. The Program is described in detail 

in section II.B entitled ‘‘PDUFA 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2013 through 

2017.’’ The Program is being evaluated 

by an independent contractor with 

expertise in assessing the quality and 

efficiency of pharmaceutical and 

biopharmaceutical development and 

regulatory review programs. As part of 

FDA’s performance commitments, FDA 

is providing a period for public 

comment on the interim assessment of 

the Program. 

DATES: See Section III, ‘‘How to 

Participate in the Public Meeting’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document for dates and times of the 

public meeting, closing dates for 

advance registration, requesting special 

accommodations due to disability, and 

information on deadlines for submitting 

either electronic or written comments to 

FDA’s Division of Dockets Management. 

ADDRESSES: See Section III, ‘‘How to 

Participate in the Public Meeting’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES