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This draft guidance also refers to 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
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22533 

1This document is available on the Internet at 

http://www.fda.gov/downloads/ForIndustry/

UserFees/PrescriptionDrugUserFee/

UCM270412.pdf. 

FOR FURTHER INFORMATION CONTACT: 

Graham Thompson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1146, 

Silver Spring, MD 20993, 301–796– 

5003, FAX: 301–847–8443, 

Graham.Thompson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The timely review of the safety and 

efficacy of new drugs and biologics is 

central to FDA’s mission to protect and 

promote the public health. Since the 

implementation of PDUFA I in 1993, 

FDA has used PDUFA resources to 

significantly reduce the time it takes to 

evaluate new drugs without 

compromising FDA’s rigorous standards 

for drug safety and efficacy. In return for 

these additional resources, FDA agreed 

to certain review performance goals, 

such as completing reviews of NDAs 

and BLAs and taking regulatory actions 

on them within predictable timeframes. 

These changes revolutionized the 

review process and enabled FDA to 

improve the efficiency of the 

application review process for new 

drugs and biologics without 

compromising the Agency’s high 

standards for demonstration of safety, 

efficacy, and quality of new drugs and 

biologics prior to approval. 

PDUFA provides FDA with a source 

of stable, consistent funding that has 

made possible our efforts to focus on 

promoting innovative therapies and 

helping to bring to market critical 

products for patients. The PDUFA 

program has been reauthorized every 5 

years, with the most recent 

reauthorization occurring in 2012 for 

FYs 2013–2017 (PDUFA V).1

PDUFA V introduced a new review 

program for NME NDAs and original 

BLAs to enhance review transparency 

and communication between FDA and 

applicants on these complex 

applications. FDA committed to 

engaging an independent contractor to 

evaluate the Program. The PDUFA V 

performance commitments call for an 

interim assessment of the Program to be 

published by March 31, 2015, for public 

comment. The interim assessment can 

be accessed at http://www.fda.gov/

downloads/ForIndustry/UserFees/

PrescriptionDrugUserFee/

UCM436448.pdf. 

II. PDUFA V NME NDA and Original 

BLA Review Program 

FDA’s review performance goals for 

priority and standard applications, 6 

and 10 months respectively, have been 

in place since the late 1990s. Since that 

time, additional requirements in the 

review process and scientific advances 

in product development have made 

those goals increasingly challenging to 

meet, particularly for more complex 

applications like NME NDAs and 

original BLAs. FDA further recognizes 

that increasing communication between 

the Agency and applicants during FDA’s 

review has the potential to increase 

efficiency in the review process. 

To promote greater transparency and 

improve communication between the 

FDA review team and the applicant, 

FDA implemented a new review model 

for NME NDAs and original BLAs in 

PDUFA V. The Program provides 

opportunities for increased 

communication between FDA and 

applicants, including mid-cycle and 

late-cycle meetings. To accommodate 

the increased interaction during 

regulatory review and to address the 

need for additional time to review these 

complex applications, FDA’s review 

clock begins after the 60-day 

administrative filing review period for 

applications reviewed under the 

Program. 

The goal of the Program is to improve 

the efficiency and effectiveness of the 

first-cycle review process by increasing 

communications during application 

review. This will provide sponsors with 

the opportunity to clarify previous 

submissions and provide additional 

data and analyses that are readily 

available, potentially avoiding the need 

for an additional review cycle when 

concerns can be promptly resolved but 

without compromising FDA’ standards 

for approval. 

To understand the Program’s effect on 

the review of these applications, the 

Program is being evaluated by an 

independent contractor. In addition to 

publishing an interim assessment and 

opening a docket for public comments, 

a public meeting will be held on May 

20, 2015, where the interim assessment 

will be discussed and public 

stakeholders may present their views on 

the Program to date. The final 

assessment of the Program will be 

published for public comment by 

December 31, 2016, and will be 

followed by a public meeting by March 

30, 2017. 

III. How To Participate in the Public 

Meeting 

FDA is holding the public meeting on 

May 20, 2015, from 10 a.m. to 1 p.m. 

Due to limited space and time, we 

encourage all persons who wish to 

attend the meeting to register in 

advance. There is no fee to register for 

the public meeting, and registration will 

be on a first-come, first-served basis. 

Table 1 of this document provides 

information on participation in the 

public meeting. 

TABLE 1—INFORMATION ON PARTICIPATING IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET 1

Dates Electronic addresses Addresses Other information 

Attend public 

meeting.

May 20, 2015, 

from 10 a.m. 

to 1 p.m.

Please preregister at https://

www.nmepdufa.eventbrite.com.

FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, Section A 

of the Great Room (Rm. 1503) 

Silver Spring, MD 20993.

Participants must enter through 

Building 1 and undergo security screening. For more information on parking and security 

procedures, please visit http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 

Preregister ........... Register by May 

13, 2015.

Individuals who wish to participate in person are asked to 

preregister at https://www.

nmepdufa.eventbrite.com.

We encourage the use of electronic registration, if possible.1There is no registration fee for 

the public meeting. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
22534 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 

TABLE 1—INFORMATION ON PARTICIPATING IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET 1— 

Continued 

Dates Electronic addresses Addresses Other information 

View Web cast .... May 20, 2015, 

from 10 a.m. 

to 1 p.m.

Individuals who are unable to attend the meeting in person, 

can register to view a live Web 

cast. You will be asked to indicate in your registration whether you plan to attend in person 

or via the Web cast.

...................................................... The Web cast will have closed 

captioning. 

Request special 

accommodations due to disability.

Request at least 

7 days before 

the meeting.

Graham Thompson, email: Graham.Thompson@fda.hhs.gov.See FOR FURTHER INFORMATION CONTACT.

Submit electronic 

or written comments.

Submit comments by 

June 30, 2015.

Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the instructions for submitting comments.

Mail/Hand delivery/Courier (for 

paper submissions): Division of 

Dockets Management (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 

20852.

Identify your comments with the 

docket number listed in brackets in the heading of this document. We encourage you to 

submit electronic comments by 

using the Federal eRulemaking 

Portal. 

1You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301–796–5003, FAX: 301–847–8443, Graham.Thompson@fda.hhs.gov. 

IV. Comments and Transcripts 

Regardless of attendance at the public 

meeting, interested persons may submit 

to FDA’s Division of Dockets 

Management (see Addresses in table 1) 

either electronic or written comments 

on the interim assessment of the 

Program for Enhanced Review 

Transparency and Communication for 

NME NDAs and Original BLAs. You 

only need to send one set of comments. 

Identify the comments with the docket 

number provided in brackets in the 

heading of this document. 

With respect to transcripts, please be 

advised that as soon as a transcript is 

available, it will be accessible at 

www.fda.gov/ForIndustry/UserFees/

PrescriptionDrugUserFee/

ucm327030.htm. 

Dated: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09300 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Ebola Virus Disease Therapeutics 

ACTION: Notice of Declaration Under the 

Public Readiness and Emergency 

Preparedness Act. 

SUMMARY: The Secretary is issuing a 

Declaration pursuant to section 319F–3 

of the Public Health Service Act (42 

U.S.C. 247d–6d) to provide liability 

protection for activities related to Ebola 

Virus Disease Therapeutics consistent 

with the terms of the Declaration. 

DATES: The Declaration is effective as of 

February 27, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Lurie, MD, MSPH, Assistant 

Secretary for Preparedness and 

Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW., Washington, DC 20201, Telephone 

(202) 205–2882 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

Background 

The Public Readiness and Emergency 

Preparedness Act (‘‘PREP Act’’) 

authorizes the Secretary of Health and 

Human Services (‘‘the Secretary’’) to 

issue a Declaration to provide liability 

immunity to certain individuals and 

entities (‘‘Covered Persons’’) against any 

claim of loss caused by, arising out of, 

relating to, or resulting from the 

administration or use of medical 

countermeasures (‘‘Covered 

Countermeasures’’), except for claims 

that meet the PREP Act’s definition of 

willful misconduct. Using this 

authority, the Secretary is issuing a 

Declaration to provide liability 

immunity to Covered Persons for 

activities related to the Covered 

Countermeasures, Ebola Virus Disease 

Therapeutics as listed in Section VI of 

the Declaration, consistent with the 

terms of this Declaration. 

The PREP Act was enacted on 

December 30, 2005, as Public Law 109– 

148, Division C, Section 2. It amended 

the Public Health Service (‘‘PHS’’) Act, 

adding section 319F–3, which addresses 

liability immunity, and section 319F–4, 

which creates a compensation program. 

These sections are codified in the U.S. 

Code as 42 U.S.C. 247d–6d and 42 

U.S.C. 247d–6e, respectively. 

The Pandemic and All-Hazards 

Preparedness Reauthorization Act 

(PAHPRA), Public Law 113–5, was 

enacted on March 13, 2013. Among 

other things, PAHPRA added sections 

564A and 564B to the Federal Food, 

Drug, and Cosmetic (FD&C) Act to 

provide new emergency authorities for 

dispensing approved products in 

emergencies and products held for 

emergency use. 

PAHPRA accordingly amended the 

definitions of ‘‘Covered 

Countermeasures’’ and ‘‘qualified 

pandemic and epidemic products’’ in 

section 319F–3 of the Public Health 

Service Act (the PREP Act provisions), 

so that products made available under 

these new FD&C Act authorities could 

be covered under PREP Act 

Declarations. PAHPRA also extended 

the definition of qualified pandemic and 

epidemic products that may be covered 

under a PREP Act Declaration to include 

products or technologies intended to 

enhance the use or effect of a drug, 

biological product, or device used 

against the pandemic or epidemic or 

against adverse events from these 

products. 

The Ebola virus causes an acute, 

serious illness that is often fatal. Since 

March 2014, West Africa has been 

experiencing the largest and most 

complex Ebola outbreak since the Ebola 


asabaliauskas on DSK5VPTVN1PROD with NOTICES