80 FR 22532 - Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 77 (April 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22532-22534 | |
| FR Document | 2015-09300 |
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)] [Notices] [Pages 22532-22534] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09300] ----------------------------------------------------------------------- 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. [[Page 22533]] 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, [email protected]. 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\ --------------------------------------------------------------------------- \1\ This document is available on the Internet at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. --------------------------------------------------------------------------- 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, Please preregister FDA White Oak Participants must from 10 a.m. at https:// Campus, 10903 New enter through to 1 p.m. www.nmepdufa.eventb Hampshire Ave., Building 1 and rite.com. Bldg. 31 Conference undergo security Center, Section A screening. For more of the Great Room information on (Rm. 1503) Silver parking and Spring, MD 20993. security procedures, please visit http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Preregister.................. Register by May Individuals who wish We encourage the use There is no 13, 2015. to participate in of electronic registration fee person are asked to registration, if for the public preregister at possible.\1\ meeting. https://www.nmepdufa.eventbrite.com. [[Page 22534]] View Web cast................ May 20, 2015, Individuals who are .................... The Web cast will from 10 a.m. unable to attend have closed to 1 p.m. the meeting in captioning. 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. Request special Request at Graham Thompson, See FOR FURTHER accommodations due to least 7 days email: INFORMATION CONTACT. disability. before the Graham.Thompson@fda meeting. .hhs.gov. Submit electronic or written Submit comments Federal eRulemaking Mail/Hand delivery/ Identify your comments. by June 30, Portal: http:// Courier (for paper comments with the 2015. www.regulations.gov submissions): docket number . Follow the Division of Dockets listed in brackets instructions for Management (HFA- in the heading of submitting comments. 305), Food and Drug this document. We Administration, encourage you to 5630 Fishers Lane, submit electronic Rm. 1061, comments by using Rockville, MD 20852. the Federal eRulemaking Portal. ---------------------------------------------------------------------------------------------------------------- \1\ You 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, [email protected]. 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
![22532 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Average
Number of
Number of Total annual burden per
Type of submission responses per Total hours
respondents responses response
respondent (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 III. Comments SUMMARY: The Food and Drug
previously approved collections of Interested persons may submit either Administration (FDA) is announcing the
information found in FDA regulations electronic comments regarding this establishment of a docket to obtain
and collections of information that are document to http://www.regulations.gov comments on the interim assessment of
currently under OMB review. The or written comments to the Division of the Program for Enhanced Review
collections of information in 21 CFR Dockets Management (see ADDRESSES). It Transparency and Communication for
202.1, including requests for advisory is only necessary to send one set of New Molecular Entity (NME) New Drug
comments, resubmissions, and comments. Identify comments with the Applications (NDAs) and Original
amendments for advertisements, have docket number found in brackets in the Biologics License Applications (BLAs)
been approved under OMB control heading of this document. Received (the Program). FDA is also announcing
number 0910–0686; the collections of comments may be seen in the Division a public meeting where the interim
information in 21 CFR 601.45 of Dockets Management between 9 a.m. assessment will be discussed and public
(presubmission of promotional materials and 4 p.m., Monday through Friday, and stakeholders may present their views on
for accelerated approval products under will be posted to the docket at http:// the Program to date.
part 601) have been approved under www.regulations.gov. The Program is part of the FDA
OMB control number 0910–0338; the performance commitments under the
collections of information for FDA Form IV. Electronic Access
fifth authorization of the Prescription
2253 and the presubmission of Persons with access to the Internet Drug User Fee Act (PDUFA), which
promotional materials for accelerated may obtain the document at http:// enables FDA to collect user fees for the
approval products under part 314 have www.fda.gov/Drugs/ review of human drug and biologics
been approved under OMB control GuidanceCompliance applications for fiscal years (FYs) 2013–
number 0910–0001. FDA has also RegulatoryInformation/Guidances/ 2017. The Program is described in detail
published in the Federal Register a 60- default.htm, http://www.fda.gov/ in section II.B entitled ‘‘PDUFA
day notice soliciting public comments BiologicsBloodVaccines/Guidance Reauthorization Performance Goals and
on the collections of information that ComplianceRegulatoryInformation/ Procedures Fiscal Years 2013 through
result from the submission of television default.htm, or http:// 2017.’’ The Program is being evaluated
advertisements under section 503C of www.regulations.gov. by an independent contractor with
the FD&C Act (21 U.S.C. 353c) (77 FR Dated: April 16, 2015. expertise in assessing the quality and
14811, March 13, 2012). These burden Leslie Kux, efficiency of pharmaceutical and
estimates do not change as a result of Associate Commissioner for Policy. biopharmaceutical development and
this guidance. This is because new [FR Doc. 2015–09297 Filed 4–21–15; 8:45 am] regulatory review programs. As part of
burdens for establishing the means for BILLING CODE 4164–01–P FDA’s performance commitments, FDA
submitting materials in electronic form is providing a period for public
to comply with this guidance would be comment on the interim assessment of
negated by the savings in burden from DEPARTMENT OF HEALTH AND the Program.
not having to print out the materials and HUMAN SERVICES
mail them to FDA. DATES: See Section III, ‘‘How to
Food and Drug Administration Participate in the Public Meeting’’ in the
Some firms may incur costs
SUPPLEMENTARY INFORMATION section of
associated with upgrading technology or [Docket No. FDA–2013–N–0093]
this document for dates and times of the
changing the method of submitting
Interim Assessment of the Program for public meeting, closing dates for
information to FDA, and these have
Enhanced Review Transparency and advance registration, requesting special
been described in the Federal Register
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Communication; Public Meeting and accommodations due to disability, and
notice for the revised draft guidance for
Establishment of Docket information on deadlines for submitting
industry entitled ‘‘Providing Regulatory
either electronic or written comments to
Submissions in Electronic Format— AGENCY: Food and Drug Administration, FDA’s Division of Dockets Management.
Certain Human Pharmaceutical Product HHS.
Applications and Related Submissions ADDRESSES: See Section III, ‘‘How to
ACTION: Notice of public meeting and
Using the Electronic Common Technical Participate in the Public Meeting’’ in the
establishment of docket; request for
Document Specifications’’ (79 FR 43494, SUPPLEMENTARY INFORMATION section of
comments.
July 25, 2014). this document.
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![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, Individuals who are unable to at- ...................................................... The Web cast will have closed
from 10 a.m. tend the meeting in person, captioning.
to 1 p.m. can register to view a live Web
cast. You will be asked to indi-
cate in your registration wheth-
er you plan to attend in person
or via the Web cast.
Request special Request at least Graham Thompson, email: Gra- See FOR FURTHER INFORMA-
accommoda- 7 days before ham.Thompson@fda.hhs.gov. TION CONTACT.
tions due to dis- the meeting.
ability.
Submit electronic Submit com- Federal eRulemaking Portal: Mail/Hand delivery/Courier (for Identify your comments with the
or written com- ments by http://www.regulations.gov. Fol- paper submissions): Division of docket number listed in brack-
ments. June 30, 2015. low the instructions for submit- Dockets Management (HFA– ets in the heading of this docu-
ting comments. 305), Food and Drug Adminis- ment. We encourage you to
tration, 5630 Fishers Lane, submit electronic comments by
Rm. 1061, Rockville, MD using the Federal eRulemaking
20852. Portal.
1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your reg-
istration 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 protection for activities related to Ebola the Public Health Service (‘‘PHS’’) Act,
Virus Disease Therapeutics consistent adding section 319F–3, which addresses
Regardless of attendance at the public
with the terms of the Declaration. liability immunity, and section 319F–4,
meeting, interested persons may submit
DATES: The Declaration is effective as of which creates a compensation program.
to FDA’s Division of Dockets
February 27, 2015. These sections are codified in the U.S.
Management (see Addresses in table 1)
FOR FURTHER INFORMATION CONTACT: Code as 42 U.S.C. 247d–6d and 42
either electronic or written comments
Nicole Lurie, MD, MSPH, Assistant U.S.C. 247d–6e, respectively.
on the interim assessment of the
Program for Enhanced Review Secretary for Preparedness and The Pandemic and All-Hazards
Transparency and Communication for Response, Office of the Secretary, Preparedness Reauthorization Act
NME NDAs and Original BLAs. You Department of Health and Human (PAHPRA), Public Law 113–5, was
only need to send one set of comments. Services, 200 Independence Avenue enacted on March 13, 2013. Among
Identify the comments with the docket SW., Washington, DC 20201, Telephone other things, PAHPRA added sections
number provided in brackets in the (202) 205–2882 (this is not a toll-free 564A and 564B to the Federal Food,
heading of this document. number). Drug, and Cosmetic (FD&C) Act to
With respect to transcripts, please be provide new emergency authorities for
SUPPLEMENTARY INFORMATION:
advised that as soon as a transcript is dispensing approved products in
Background emergencies and products held for
available, it will be accessible at
www.fda.gov/ForIndustry/UserFees/ The Public Readiness and Emergency emergency use.
PrescriptionDrugUserFee/ Preparedness Act (‘‘PREP Act’’) PAHPRA accordingly amended the
ucm327030.htm. authorizes the Secretary of Health and definitions of ‘‘Covered
Human Services (‘‘the Secretary’’) to Countermeasures’’ and ‘‘qualified
Dated: April 16, 2015. pandemic and epidemic products’’ in
issue a Declaration to provide liability
Leslie Kux, section 319F–3 of the Public Health
immunity to certain individuals and
Associate Commissioner for Policy. entities (‘‘Covered Persons’’) against any Service Act (the PREP Act provisions),
[FR Doc. 2015–09300 Filed 4–21–15; 8:45 am] claim of loss caused by, arising out of, so that products made available under
BILLING CODE 4164–01–P relating to, or resulting from the these new FD&C Act authorities could
administration or use of medical be covered under PREP Act
countermeasures (‘‘Covered Declarations. PAHPRA also extended
DEPARTMENT OF HEALTH AND Countermeasures’’), except for claims the definition of qualified pandemic and
HUMAN SERVICES that meet the PREP Act’s definition of epidemic products that may be covered
willful misconduct. Using this under a PREP Act Declaration to include
Office of the Secretary products or technologies intended to
authority, the Secretary is issuing a
Declaration to provide liability enhance the use or effect of a drug,
Ebola Virus Disease Therapeutics
immunity to Covered Persons for biological product, or device used
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice of Declaration Under the activities related to the Covered against the pandemic or epidemic or
Public Readiness and Emergency Countermeasures, Ebola Virus Disease against adverse events from these
Preparedness Act. Therapeutics as listed in Section VI of products.
the Declaration, consistent with the The Ebola virus causes an acute,
SUMMARY: The Secretary is issuing a terms of this Declaration. serious illness that is often fatal. Since
Declaration pursuant to section 319F–3 The PREP Act was enacted on March 2014, West Africa has been
of the Public Health Service Act (42 December 30, 2005, as Public Law 109– experiencing the largest and most
U.S.C. 247d–6d) to provide liability 148, Division C, Section 2. It amended complex Ebola outbreak since the Ebola
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Document Created: 2015-12-16 08:27:50
Document Modified: 2015-12-16 08:27:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting and establishment of docket; request for comments. | |
| 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. | |
| 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, [email protected] | |
| FR Citation | 80 FR 22532 |
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