81 FR 89109 - Final 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 81, Issue 237 (December 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 237 (December 9, 2016)
| Page Range | 89109-89110 | |
| FR Document | 2016-29589 |
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)] [Notices] [Pages 89109-89110] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29589] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-4096] Final 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 final 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 final 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 of the document 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 final assessment of the Program. DATES: The public meeting will be held on March 27, 2017, from 10 a.m. to 1 p.m. Public comments will be accepted through April 3, 2017. See the ADDRESSES section for information about submitting comments to the public docket. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 2, Conference Room 2047 E, Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For more information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-N-4096. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. [[Page 89110]] Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 improve the timeliness and predictability of new drug review while maintaining FDA's rigorous standards for drug quality, safety and efficacy. With the availability of these additional fee resources, FDA was able to agree to certain review performance goals, including a complete review of NDAs and BLAs and taking regulatory action within specified timeframes. The managed review processes put in place to accomplish this, and the process enhancements including investments in modernized post-market safety and regulatory science over subsequent reauthorizations of PDUFA, have revolutionized the new drug review process, helping to bring critical products to market for patients. The PDUFA program has been reauthorized every 5 years, with the most recent and fifth authorization occurring in 2012. The PDUFA V Performance Goals and Procedures for Fiscal Years 2013 through 2017 can be accessed 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 to understand the Program's effect on the review of these applications. The interim assessment was published March 31, 2015, and can be accessed at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf. The PDUFA V performance commitments also call for a final assessment of the Program to be published by December 31, 2016, for public comment. The final assessment can be accessed at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm. A public meeting will be held on March 27, 2017, where the final assessment will be discussed and public stakeholders may present their views on the Program. II. PDUFA V NME NDA and Original BLA Review Program FDA's performance goals for review of priority and standard new drug 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 and transparency 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 without compromising FDA's standards for approval. III. Meeting Attendance and Participation FDA is holding the public meeting on March 27, 2017, from 10 a.m. to 1 p.m. If you wish to attend this public meeting, visit: https://nmemeeting.eventbrite.com. Please register by March 20, 2017. If you are unable to attend the public meeting in person, you can register to view a live Webcast of the public meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first- served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the public meeting will not be possible. If you need special accommodations because of a disability, please contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the public meeting. FDA will hold an open public comment period to give the public an opportunity to comment during the public meeting. Registration for open public comment will occur at the registration desk on the day of the public meeting on a first-come, first-served basis. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A link to the transcript will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm. Dated: December 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29589 Filed 12-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices 89109
to the Administration for Children and user fees for the review of human drug do not wish to be made available to the
Families, Office of Planning, Research and biologics applications for fiscal public, submit the comment as a
and Evaluation, 330 C Street SW., years (FYs) 2013–2017. The Program is written/paper submission and in the
Washington, DC 20201. Attn: ACF described in detail in section II.B of the manner detailed (see ‘‘Written/Paper
Reports Clearance Officer. Email document entitled ‘‘PDUFA Submissions’’ and ‘‘Instructions’’).
address: infocollection@acf.hhs.gov. All Reauthorization Performance Goals and
Written/Paper Submissions
requests should be identified by the title Procedures Fiscal Years 2013 through
of the information collection. 2017.’’ The Program is being evaluated Submit written/paper submissions as
The Department specifically requests by an independent contractor with follows:
comments on: (a) Whether the proposed expertise in assessing the quality and • Mail/Hand delivery/Courier (for
collection of information is necessary efficiency of pharmaceutical and written/paper submissions): Division of
for the proper performance of the biopharmaceutical development and Dockets Management (HFA–305), Food
functions of the agency, including regulatory review programs. As part of and Drug Administration, 5630 Fishers
whether the information shall have FDA’s performance commitments, FDA Lane, Rm. 1061, Rockville, MD 20852.
is providing a period for public • For written/paper comments
practical utility; (b) the accuracy of the
comment on the final assessment of the submitted to the Division of Dockets
agency’s estimate of the burden of the
Program. Management, FDA will post your
proposed collection of information; (c)
DATES: The public meeting will be held
comment, as well as any attachments,
the quality, utility, and clarity of the
on March 27, 2017, from 10 a.m. to 1 except for information submitted,
information to be collected; and (d)
p.m. Public comments will be accepted marked and identified, as confidential,
ways to minimize the burden of the
through April 3, 2017. See the if submitted as detailed in
collection of information on
ADDRESSES section for information about
‘‘Instructions.’’
respondents, including through the use Instructions: All submissions received
of automated collection techniques or submitting comments to the public
must include the Docket No. FDA–
other forms of information technology. docket. See the SUPPLEMENTARY
2016–N–4096. Received comments will
Consideration will be given to INFORMATION section for registration date
be placed in the docket and, except for
comments and suggestions submitted and information.
those submitted as ‘‘Confidential
within 60 days of this publication. ADDRESSES: The public meeting will be Submissions,’’ publicly viewable at
held at the FDA White Oak Campus, http://www.regulations.gov or at the
Robert Sargis,
10903 New Hampshire Ave., Bldg. 2, Division of Dockets Management
Reports Clearance Officer. Conference Room 2047 E, Silver Spring,
[FR Doc. 2016–29583 Filed 12–8–16; 8:45 am]
between 9 a.m. and 4 p.m., Monday
MD 20993–0002. Entrance for the public through Friday.
BILLING CODE 4184–01–P meeting participants (non-FDA • Confidential Submissions—To
employees) is through Building 1 where submit a comment with confidential
routine security check procedures will information that you do not wish to be
DEPARTMENT OF HEALTH AND be performed. For more information on
HUMAN SERVICES made publicly available, submit your
parking and security procedures, please comments only as a written/paper
refer to http://www.fda.gov/AboutFDA/ submission. You should submit two
Food and Drug Administration
WorkingatFDA/BuildingsandFacilities/ copies total. One copy will include the
[Docket No. FDA–2016–N–4096] WhiteOakCampusInformation/ information you claim to be confidential
ucm241740.htm. with a heading or cover note that states
Final Assessment of the Program for You may submit comments as ‘‘THIS DOCUMENT CONTAINS
Enhanced Review Transparency and follows: CONFIDENTIAL INFORMATION.’’ The
Communication; Public Meeting and
Electronic Submissions Agency will review this copy, including
Establishment of Docket
Submit electronic comments in the the claimed confidential information, in
AGENCY: Food and Drug Administration, following way: its consideration of comments. The
HHS. • Federal eRulemaking Portal: http:// second copy, which will have the
ACTION: Notice of public meeting and www.regulations.gov. Follow the claimed confidential information
establishment of docket, request for instructions for submitting comments. redacted/blacked out, will be available
comments. Comments submitted electronically, for public viewing and posted on http://
including attachments, to http:// www.regulations.gov. Submit both
SUMMARY: The Food and Drug www.regulations.gov will be posted to copies to the Division of Dockets
Administration (FDA) is announcing the the docket unchanged. Because your Management. If you do not wish your
establishment of a docket to obtain comment will be made public, you are name and contact information to be
comments on the final assessment of the solely responsible for ensuring that your made publicly available, you can
Program for Enhanced Review comment does not include any provide this information on the cover
Transparency and Communication for confidential information that you or a sheet and not in the body of your
New Molecular Entity (NME) New Drug third party may not wish to be posted, comments and you must identify this
Applications (NDAs) and Original such as medical information, your or information as ‘‘confidential.’’ Any
Biologics License Applications (BLAs) anyone else’s Social Security number, or information marked as ‘‘confidential’’
(the Program). FDA is also announcing confidential business information, such will not be disclosed except in
a public meeting where the final accordance with 21 CFR 10.20 and other
mstockstill on DSK3G9T082PROD with NOTICES
as a manufacturing process. Please note
assessment will be discussed and public that if you include your name, contact applicable disclosure law. For more
stakeholders may present their views on information, or other information that information about FDA’s posting of
the Program to date. The Program is part identifies you in the body of your comments to public dockets, see 80 FR
of the FDA performance commitments comments, that information will be 56469, September 18, 2015, or access
under the fifth authorization of the posted on http://www.regulations.gov. the information at: http://www.fda.gov/
Prescription Drug User Fee Act • If you want to submit a comment regulatoryinformation/dockets/
(PDUFA), which enables FDA to collect with confidential information that you default.htm.
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![89110 Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
Docket: For access to the docket to downloads/ForIndustry/UserFees/ III. Meeting Attendance and
read background documents or the PrescriptionDrugUserFee/ Participation
electronic and written/paper comments UCM436448.pdf. The PDUFA V FDA is holding the public meeting on
received, go to http:// performance commitments also call for March 27, 2017, from 10 a.m. to 1 p.m.
www.regulations.gov and insert the a final assessment of the Program to be If you wish to attend this public
docket number, found in brackets in the published by December 31, 2016, for meeting, visit: https://
heading of this document, into the public comment. The final assessment nmemeeting.eventbrite.com. Please
‘‘Search’’ box and follow the prompts can be accessed at http://www.fda.gov/ register by March 20, 2017. If you are
and/or go to the Division of Dockets ForIndustry/UserFees/PrescriptionDrug unable to attend the public meeting in
Management, 5630 Fishers Lane, Rm. UserFee/ucm327030.htm. A public person, you can register to view a live
1061, Rockville, MD 20852. meeting will be held on March 27, 2017, Webcast of the public meeting. You will
FOR FURTHER INFORMATION CONTACT: where the final assessment will be be asked to indicate in your registration
Graham Thompson, Center for Drug discussed and public stakeholders may if you plan to attend in person or via the
Evaluation and Research, Food and present their views on the Program. Webcast. Seating will be limited, so
Drug Administration, 10903 New early registration is recommended.
Hampshire Ave., Bldg. 51, Rm. 1146, II. PDUFA V NME NDA and Original Registration is free and will be on a first-
Silver Spring, MD 20993, 301–796– BLA Review Program come, first-served basis. However, FDA
5003, FAX: 301–847–8443, may limit the number of participants
Graham.Thompson@fda.hhs.gov. FDA’s performance goals for review of
from each organization based on space
SUPPLEMENTARY INFORMATION:
priority and standard new drug
limitations. Registrants will receive
applications, 6 and 10 months confirmation once they have been
I. Background respectively, have been in place since accepted. Onsite registration on the day
The timely review of the safety and the late 1990s. Since that time, of the public meeting will not be
efficacy of new drugs and biologics is additional requirements in the review possible. If you need special
central to FDA’s mission to protect and process and scientific advances in accommodations because of a disability,
promote the public health. Since the product development have made those please contact Graham Thompson (see
implementation of PDUFA I in 1993, goals increasingly challenging to meet, FOR FURTHER INFORMATION CONTACT) at
FDA has used PDUFA resources to particularly for more complex least 7 days before the public meeting.
improve the timeliness and applications like NME NDAs and FDA will hold an open public
predictability of new drug review while original BLAs. FDA further recognizes comment period to give the public an
maintaining FDA’s rigorous standards that increasing communication and opportunity to comment during the
for drug quality, safety and efficacy. transparency between the Agency and public meeting. Registration for open
With the availability of these additional applicants during FDA’s review has the public comment will occur at the
fee resources, FDA was able to agree to potential to increase efficiency in the registration desk on the day of the
certain review performance goals, review process. public meeting on a first-come, first-
including a complete review of NDAs served basis.
and BLAs and taking regulatory action To promote greater transparency and
Transcripts: Please be advised that as
within specified timeframes. The improve communication between the
soon as a transcript of the public
managed review processes put in place FDA review team and the applicant, meeting is available, it will be accessible
to accomplish this, and the process FDA implemented a new review model at https://www.regulations.gov. It may
enhancements including investments in for NME NDAs and original BLAs in be viewed at the Division of Dockets
modernized post-market safety and PDUFA V. The Program provides Management (see ADDRESSES). A link to
regulatory science over subsequent opportunities for increased the transcript will also be available on
reauthorizations of PDUFA, have communication between FDA and the Internet at http://www.fda.gov/
revolutionized the new drug review applicants, including mid-cycle and Drugs/NewsEvents/ucm501389.htm.
process, helping to bring critical late-cycle meetings. To accommodate
Dated: December 2, 2016.
products to market for patients. The the increased interaction during
Leslie Kux,
PDUFA program has been reauthorized regulatory review and to address the
every 5 years, with the most recent and Associate Commissioner for Policy.
need for additional time to review these
fifth authorization occurring in 2012. [FR Doc. 2016–29589 Filed 12–8–16; 8:45 am]
complex applications, FDA’s review
The PDUFA V Performance Goals and clock begins after the 60-day BILLING CODE 4164–01–P
Procedures for Fiscal Years 2013 administrative filing review period for
through 2017 can be accessed at http:// applications reviewed under the
www.fda.gov/downloads/ForIndustry/ DEPARTMENT OF HEALTH AND
Program. HUMAN SERVICES
UserFees/PrescriptionDrugUserFee/
UCM270412.pdf. The goal of the Program is to improve
the efficiency and effectiveness of the Food and Drug Administration
PDUFA V introduced a new review
program for NME NDAs and original first-cycle review process by increasing [Docket No. FDA–2016–D–1814]
BLAs to enhance review transparency communications during application
and communication between FDA and review. This will provide sponsors with Preparation of Food Contact
applicants on these complex the opportunity to clarify previous Notifications for Food Contact
mstockstill on DSK3G9T082PROD with NOTICES
applications. FDA committed to submissions and provide additional Substances in Contact With Infant
engaging an independent contractor to data and analyses that are readily Formula and/or Human Milk; Draft
evaluate the Program to understand the available, potentially avoiding the need Guidance for Industry; Availability
Program’s effect on the review of these for an additional review cycle when AGENCY: Food and Drug Administration,
applications. The interim assessment concerns can be promptly resolved HHS.
was published March 31, 2015, and can without compromising FDA’s standards
ACTION: Notice of availability.
be accessed at http://www.fda.gov/ for approval.
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Document Created: 2018-02-14 09:03:55
Document Modified: 2018-02-14 09:03:55
| 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 | The public meeting will be held on March 27, 2017, from 10 a.m. to 1 p.m. Public comments will be accepted through April 3, 2017. See | |
| 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 | 81 FR 89109 |
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