82 FR 13634 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 48 (March 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 48 (March 14, 2017)
| Page Range | 13634-13635 | |
| FR Document | 2017-04981 |
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)] [Notices] [Pages 13634-13635] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04981] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0402] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives.'' The topics to be discussed will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2018 Regulatory Science Plan. DATES: The public workshop will be held on May 3, 2017, from 8:30 a.m. to 4:30 p.m. The registration deadline to attend either in person, or virtually via web cast, is April 5, 2017. Comments regarding this public workshop may be submitted March 2, 2017, through June 2, 2017. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, 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: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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-2013-N-0402 for ``Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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: Stephanie Choi, Center for Drug [[Page 13635]] Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 4736, Silver Spring, MD 20993, 240-402- 7960, [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In July 2012, Congress passed GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public access to safe, high-quality generic drugs and modernize the generic drug program. To support this goal, FDA agreed in the GDUFA commitment letter to work with industry and interested stakeholders on identifying regulatory science research priorities specific to generic drugs for each fiscal year covered by GDUFA. The commitment letter outlines FDA's performance goals and procedures under the GDUFA program for the years 2012-2017. The commitment letter can be found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf. II. Topics for Discussion at the Public Workshop The purpose of the May public workshop is to obtain input from industry and other interested stakeholders on the identification of generic drug regulatory science priorities for FY 2018. FDA is holding this public workshop because the Agency intends to continue its regulatory science initiatives upon reauthorization of GDUFA (i.e., GDUFA II) for FYs 2018-2022 (see Generic Drug User Fees; Public Meeting; Request for Comments, 81 FR 66035, September 26, 2016). To help fulfill its mission, FDA is particularly interested in receiving input on the following topics: Opportunities for scientific or technical advancements that would help to overcome specific barriers for industry that currently limit the availability of generic drug products. Innovative approaches to pre-approval development of generic drugs, including new methodologies for product design and manufacturing, and design and conduct of in vitro, ex vivo, and clinical studies and identification of scientifically robust strategies for demonstration of bioequivalence for various product classes. Innovation in scientific approaches to evaluating the therapeutic equivalence of generic drug products throughout their life cycle. Identification of high-impact public health issues involving generic drugs that can be addressed by the prioritized allocation of FY 2018 funding for regulatory science research. Identification of specific issues related to generic drug products where scientific recommendations and/or clarifications are needed in developing and/or revising FDA's guidance for industry. Strategies for enhancing quality and equivalence risk management during generic drug product development, during regulatory review, and/or throughout the drug product's life cycle. FDA will consider all comments made at this workshop or received through the docket (see ADDRESSES) as it develops its FY 2018 regulatory science priorities. Additional information concerning GDUFA, including the text of the law and the commitment letter, can be found at http://www.fda.gov/gdufa. III. Participating in the Public Workshop Registration: To register to attend ``Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop'' in-person, or to attend virtually via web cast, please send an email to [email protected] by April 5, 2017. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Any person without email access can register by contacting Stephanie Choi (see FOR FURTHER INFORMATION CONTACT). If you need special accommodations because of a disability, please contact Stephanie Choi (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the workshop. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by April 5, 2017, midnight eastern standard time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. Requests for Oral Presentations: During online registration you may indicate if you wish to present during the public comment session and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by April 19, 2017. All requests to make oral presentations must be received by the close of registration on April 5, 2017, midnight eastern standard time. If selected for presentation, any presentation materials must be emailed to [email protected] no later than April 26, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be web cast. To join via the web cast, please go to https://collaboration.fda.gov/gpw517/. Please register in advance for web cast per the instructions provided in this section. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop 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/GDUFARegScience. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-04981 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
![13634 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
incorporate and formalize knowledge DATES: The public workshop will be comment, as well as any attachments,
shared with FDA by patient held on May 3, 2017, from 8:30 a.m. to except for information submitted,
stakeholders and FDA’s relationships 4:30 p.m. The registration deadline to marked and identified, as confidential,
with patient communities, and attend either in person, or virtually via if submitted as detailed in
• developing a scalable and forward- web cast, is April 5, 2017. Comments ‘‘Instructions.’’
looking platform for communicating regarding this public workshop may be Instructions: All submissions received
with patient stakeholders, particularly submitted March 2, 2017, through June must include the Docket No. FDA–
online channels. 2, 2017. 2013–N–0402 for ‘‘Generic Drug User
Under this proposal to enhance ADDRESSES: The public workshop will Fee Amendments of 2012; Regulatory
mechanisms for patient engagement at be held at the FDA White Oak Campus, Science Initiatives; Public Workshop;
FDA, a new ‘‘Office of Patient Affairs’’ 10903 New Hampshire Ave., Building Request for Comments.’’ Received
would be directly accountable to the 31 Conference Center, the Great Room comments will be placed in the docket
medical product Centers through clear (Rm. 1503, Section A), Silver Spring, and, except for those submitted as
governance structures. In addition, a MD 20993–0002. Entrance for the public ‘‘Confidential Submissions,’’ publicly
regular evaluation of this central office workshop participants (non-FDA viewable at https://www.regulations.gov
and of FDA’s overall patient engagement employees) is through Building 1, where or at the Division of Dockets
efforts is proposed. This evaluation will routine security check procedures will Management between 9 a.m. and 4 p.m.,
include feedback from external be performed. For parking and security Monday through Friday.
stakeholders (including patients and information, please refer to http:// • Confidential Submissions—To
their advocates) on a biennial basis to www.fda.gov/AboutFDA/ submit a comment with confidential
best ensure the Agency’s ongoing WorkingatFDA/BuildingsandFacilities/ information that you do not wish to be
responsiveness to the needs of patient WhiteOakCampusInformation/ made publicly available, submit your
communities. ucm241740.htm. comments only as a written/paper
Dated: March 9, 2017. You may submit comments as submission. You should submit two
Leslie Kux, follows: copies total. One copy will include the
Associate Commissioner for Policy. Electronic Submissions information you claim to be confidential
[FR Doc. 2017–04982 Filed 3–13–17; 8:45 am] with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
BILLING CODE 4164–01–P
following way: CONFIDENTIAL INFORMATION.’’ The
• Federal eRulemaking Portal: Agency will review this copy, including
DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the the claimed confidential information, in
HUMAN SERVICES instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
Food and Drug Administration including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
[Docket No. FDA–2013–N–0402] the docket unchanged. Because your for public viewing and posted on
Generic Drug User Fee Amendments of comment will be made public, you are https://www.regulations.gov. Submit
2012; Regulatory Science Initiatives; solely responsible for ensuring that your both copies to the Division of Dockets
Public Workshop; Request for comment does not include any Management. If you do not wish your
Comments confidential information that you or a name and contact information to be
third party may not wish to be posted, made publicly available, you can
AGENCY: Food and Drug Administration, such as medical information, your or provide this information on the cover
HHS. anyone else’s Social Security number, or sheet and not in the body of your
ACTION: Notice of public workshop. confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
SUMMARY: The Food and Drug that if you include your name, contact
Administration (FDA, the Agency, or information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
we) is announcing the following public identifies you in the body of your
workshop entitled ‘‘Generic Drug User accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
Fee Amendments of 2012; Regulatory posted on https://www.regulations.gov.
Science Initiatives.’’ The topics to be information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
discussed will provide an overview of with confidential information that you
the current status of regulatory science 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
initiatives for generic drugs and an public, submit the comment as a
opportunity for public input on research regulatoryinformation/dockets/
written/paper submission and in the default.htm.
priorities in this area. FDA is seeking manner detailed (see ‘‘Written/Paper
this input from a variety of Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
stakeholders—industry, academia,
patient advocates, professional societies, Written/Paper Submissions electronic and written/paper comments
and other interested parties—as it Submit written/paper submissions as received, go to https://
fulfills its commitment under the www.regulations.gov and insert the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
follows:
Generic Drug User Fee Amendments of • Mail/Hand delivery/Courier (for docket number, found in brackets in the
2012 (GDUFA) to develop an annual list written/paper submissions): Division of heading of this document, into the
of regulatory science initiatives specific Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
to generic drugs. FDA will take the and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
information it obtains from the public Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
workshop into account in developing • For written/paper comments 1061, Rockville, MD 20852.
the fiscal year (FY) 2018 Regulatory submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
Science Plan. Management, FDA will post your Stephanie Choi, Center for Drug
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![Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices 13635
Evaluation and Research, Food and equivalence of generic drug products urged to consolidate or coordinate their
Drug Administration, 10903 New throughout their life cycle. presentations. Following the close of
Hampshire Ave., Bldg 75, Rm. 4736, • Identification of high-impact public registration, FDA will determine the
Silver Spring, MD 20993, 240–402– health issues involving generic drugs amount of time allotted to each
7960, Stephanie.Choi@fda.hhs.gov; or that can be addressed by the prioritized presenter and the approximate time
Robert Lionberger, Center for Drug allocation of FY 2018 funding for each oral presentation is to begin, and
Evaluation and Research, Food and regulatory science research. will select and notify participants by
Drug Administration, 10903 New • Identification of specific issues April 19, 2017. All requests to make oral
Hampshire Ave., Bldg 75, Rm. 4722, related to generic drug products where presentations must be received by the
Silver Spring, MD 20993, 240–402– scientific recommendations and/or close of registration on April 5, 2017,
7957, Robert.Lionberger@fda.hhs.gov. clarifications are needed in developing midnight eastern standard time. If
SUPPLEMENTARY INFORMATION: and/or revising FDA’s guidance for selected for presentation, any
industry. presentation materials must be emailed
I. Background • Strategies for enhancing quality and to GDUFARegulatoryScience@
In July 2012, Congress passed GDUFA equivalence risk management during fda.hhs.gov no later than April 26, 2017.
(Title III of the Food and Drug generic drug product development, No commercial or promotional material
Administration Safety and Innovation during regulatory review, and/or will be permitted to be presented or
Act (Pub. L. 112–144)). GDUFA is throughout the drug product’s life cycle. distributed at the public workshop.
designed to enhance public access to FDA will consider all comments made Streaming Webcast of the Public
safe, high-quality generic drugs and at this workshop or received through the Workshop: This public workshop will
modernize the generic drug program. To docket (see ADDRESSES) as it develops its also be web cast. To join via the web
support this goal, FDA agreed in the FY 2018 regulatory science priorities. cast, please go to https://
GDUFA commitment letter to work with Additional information concerning collaboration.fda.gov/gpw517/. Please
industry and interested stakeholders on GDUFA, including the text of the law register in advance for web cast per the
identifying regulatory science research and the commitment letter, can be instructions provided in this section.
priorities specific to generic drugs for found at http://www.fda.gov/gdufa. If you have never attended a Connect
each fiscal year covered by GDUFA. The III. Participating in the Public Pro event before, test your connection at
commitment letter outlines FDA’s Workshop https://collaboration.fda.gov/common/
performance goals and procedures help/en/support/meeting_test.htm. To
under the GDUFA program for the years Registration: To register to attend
get a quick overview of the Connect Pro
2012–2017. The commitment letter can ‘‘Generic Drug User Fee Amendments of
program, visit http://www.adobe.com/
be found at http://www.fda.gov/ 2012; Regulatory Science Initiatives;
go/connectpro_overview. FDA has
downloads/ForIndustry/UserFees/ Public Workshop’’ in-person, or to
verified the Web site addresses in this
GenericDrugUserFees/UCM282505.pdf. attend virtually via web cast, please
document, as of the date this document
send an email to
II. Topics for Discussion at the Public publishes in the Federal Register, but
GDUFARegulatoryScience@fda.hhs.gov
Workshop Web sites are subject to change over
by April 5, 2017. Please provide
time.
The purpose of the May public complete contact information for each Transcripts: Please be advised that as
workshop is to obtain input from attendee, including name, title, soon as a transcript of the public
industry and other interested affiliation, address, email, and workshop is available, it will be
stakeholders on the identification of telephone. Any person without email accessible at https://
generic drug regulatory science access can register by contacting www.regulations.gov. It may be viewed
priorities for FY 2018. FDA is holding Stephanie Choi (see FOR FURTHER at the Division of Dockets Management
this public workshop because the INFORMATION CONTACT). If you need
(see ADDRESSES). A link to the transcript
Agency intends to continue its special accommodations because of a will also be available on the Internet at
regulatory science initiatives upon disability, please contact Stephanie http://www.fda.gov/GDUFARegScience.
reauthorization of GDUFA (i.e., GDUFA Choi (see FOR FURTHER INFORMATION
II) for FYs 2018–2022 (see Generic Drug CONTACT) at least 7 days before the Dated: March 9, 2017.
User Fees; Public Meeting; Request for workshop. Leslie Kux,
Comments, 81 FR 66035, September 26, Registration is free and based on Associate Commissioner for Policy.
2016). To help fulfill its mission, FDA space availability, with priority given to [FR Doc. 2017–04981 Filed 3–13–17; 8:45 am]
is particularly interested in receiving early registrants. Persons interested in BILLING CODE 4164–01–P
input on the following topics: attending this public workshop must
• Opportunities for scientific or register by April 5, 2017, midnight
technical advancements that would help eastern standard time. Early registration DEPARTMENT OF HEALTH AND
to overcome specific barriers for is recommended because seating is HUMAN SERVICES
industry that currently limit the limited; therefore, FDA may limit the
availability of generic drug products. number of participants from each Health Resources and Services
• Innovative approaches to pre- organization. Registrants will receive Administration
approval development of generic drugs, confirmation when they have been
including new methodologies for accepted. National Advisory Council on the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
product design and manufacturing, and Requests for Oral Presentations: National Health Service Corps
design and conduct of in vitro, ex vivo, During online registration you may AGENCY: Health Resources and Service
and clinical studies and identification of indicate if you wish to present during Administration (HRSA), Department of
scientifically robust strategies for the public comment session and which Health and Human Services (HHS).
demonstration of bioequivalence for topic(s) you wish to address. We will do ACTION: Notice of meeting.
various product classes. our best to accommodate requests to
• Innovation in scientific approaches make public comments. Individuals and SUMMARY: In accordance with the
to evaluating the therapeutic organizations with common interests are Federal Advisory Committee Act, notice
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Document Created: 2017-03-14 02:51:32
Document Modified: 2017-03-14 02:51:32
| 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 workshop. | |
| Dates | The public workshop will be held on May 3, 2017, from 8:30 a.m. to 4:30 p.m. The registration deadline to attend either in person, or virtually via web cast, is April 5, 2017. Comments regarding this public workshop may be submitted March 2, 2017, through June 2, 2017. | |
| Contact | Stephanie Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 4736, Silver Spring, MD 20993, 240-402- 7960, [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, [email protected] | |
| FR Citation | 82 FR 13634 |
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