80 FR 58259 - Biosimilar User Fee Act; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 187 (September 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 187 (September 28, 2015)
| Page Range | 58259-58260 | |
| FR Document | 2015-24524 |
[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)] [Notices] [Pages 58259-58260] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24524] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3326] Biosimilar User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022. DATES: The public meeting will be held on December 18, 2015, from 9 a.m. to 2 p.m. Registration to attend the meeting must be received by November 18, 2015. See section III of this document for information on how to register for the meeting. Submit written or electronic comments by January 19, 2016. ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, in section B and C of the Great Room (Rm. 1503), Silver Spring, MD 20993. Participants must [[Page 58260]] 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. Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061. Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number found in brackets in the heading of this document. Transcripts of the meeting will be available on the FDA Web site approximately 30 days after the meeting. FOR FURTHER INFORMATION CONTACT: Sandra Benton, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796- 1042, FAX: 301-847-3529, sandra.benton@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Introduction On July 9, 2012, the Food and Drug Administration Safety and Innovation Act, which included BsUFA (Pub. L. 112-144, title IV), was signed into law by the President. BsUFA authorizes FDA to collect fees for certain activities relating to biosimilar biological product development, for certain types of applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological products are made, and on biosimilar biological products after approval. BsUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better managed biosimilar biological product review process to make biosimilar biological product therapies available to patients sooner without compromising review quality. As part of FDA's agreement with industry during the first BsUFA authorization, the Agency agreed to certain performance goals. These goals, which are captured in a Commitment Letter, apply to the process for the review of biosimilar biological product applications, including biosimilar biological product development meetings, review of applications and supplements, and other review activities. Although BsUFA is similar to the Prescription Drug User Fee Act (PDUFA) program in that it includes fees for marketing applications, manufacturing establishments, and products, there are some differences because of the relatively nascent state of the biosimilar industry in the United States. For example, at the time BsUFA was signed into law, there were no currently marketed biosimilar biological products. Accordingly, BsUFA includes fees for products in the development phase in order to generate fee revenue to support FDA's review work during this phase and enable sponsors to have meetings with FDA early in the development of biosimilar biological product candidates. Additional information concerning BsUFA, including the text of the law, the ``Biosimilar Biological Product Authorization Performance Goals And Procedures--Fiscal Years 2013 Through 2017'' (the Commitment Letter), key Federal Register documents, BsUFA-related guidances, performance reports, and financial reports may be found on the FDA Web site at http://www.fda.gov/forindustry/userfees/biosimilaruserfeeactbsufa/default.htm. II. Purpose of Public Meeting FDA is announcing a public meeting on BsUFA. The authority for BsUFA expires at the end of September 2017. Without new legislation, FDA will no longer be able to collect user fees to fund the biosimilar biological product review process. Before FDA begins negotiations with the regulated industry on BsUFA reauthorization, the Agency is holding the public meeting announced in this notice, at which members of the public may present their views on reauthorization, including any suggestions for changes to the performance goals referred to in the Commitment Letter. In addition, FDA will provide a period of 30 days after the public meeting to obtain written comments from the public. The purpose of this public meeting is to hear stakeholder views as we consider whether to retain, change, or discontinue the current BsUFA performance goals in the next BsUFA. In addition to any other relevant information the public would like to share, the FDA is interested in responses to the following two general questions:What is your assessment of the overall performance of the BsUFA program to date? What aspects of BsUFA performance goals should be retained, changed, or discontinued to further strengthen and improve the program? The meeting will likely include presentations by FDA and a series of panels representing different stakeholder groups. We will also provide an opportunity for other stakeholders to provide public comment at the meeting. FDA policy issues are beyond the scope of these reauthorization discussions. Accordingly, the comments should focus on process enhancements and funding issues, and not on policy issues. III. Meeting Attendance and Participation If you wish to attend this meeting, visit https://fdapublicmeeting-bsufa.eventbrite.com. Please register by November 18, 2015. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Your registration must also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. 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 their registrations have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Sandra Benton (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. In addition, any person may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). Comments are to be identified 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. To ensure consideration, all comments must be received by January 19, 2016. Please be advised that as soon as a transcript is available, it will be accessible at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM461774.htm. Dated: September 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24524 Filed 9-25-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices 58259
postmenopausal women have symptoms indicated for treatment of moderate to between 9 a.m. and 4 p.m., Monday
of VVA that require treatment, but some severe symptoms of vulvar and vaginal through Friday, and will be posted to
women (particularly those 5 to10 years atrophy due to menopause. Presentation the docket at http://
postmenopausal), when asked, will of basic PK and clinical pharmacology www.regulations.gov.
report one or more of the above data concepts and an informed Transcripts: Transcripts for the
symptoms, which they deem to be framework for comparing various November 10th meeting will be posted,
bothersome and self-categorize as estrogen products for prescribing when available, at http://www.fda.gov/
moderate to severe in intensity. To date, purposes. Drugs/NewsEvents/ucm401167.htm.
the Agency has approved estrogen • Discuss the level of available data Dated: September 22, 2015.
products (both estrogen-alone and supporting that a given estrogen serum
Leslie Kux,
estrogen plus progestin) for the concentration is or is not related to
adverse outcomes (for example, Associate Commissioner for Policy.
indications of ‘‘treatment of moderate to
pulmonary emboli, deep venous [FR Doc. 2015–24509 Filed 9–25–15; 8:45 am]
severe vaginal dryness, a symptom of
vulvar and vaginal atrophy due to thrombosis, and myocardial infarction). BILLING CODE 4164–01–P
menopause’’ and ‘‘treatment of • Presentation and discussion of PD
moderate to severe dyspareunia, a biomarkers for thrombosis. Presentation
of a comparison of metabolic profiles DEPARTMENT OF HEALTH AND
symptom of vulvar and vaginal atrophy
from various products, key clotting HUMAN SERVICES
due to menopause.’’
Estrogen-alone products have Boxed factors responsible for thrombosis, and
PK/PD relationships. Food and Drug Administration
Warnings stating:
(1) There is an increased risk of [Docket No. FDA–2015–N–3326]
III. Meeting Attendance and
endometrial cancer in a woman with a Participation
uterus who uses unopposed estrogen; Biosimilar User Fee Act; Public
(2) estrogen-alone therapy should not If you wish to attend this meeting, Meeting
be used for the prevention of email FDAVVAworkshop@fda.hhs.gov.
Please register by October 16, 2015. AGENCY: Food and Drug Administration,
cardiovascular disease or dementia; HHS.
(3) an increased risk of stroke and Those who are unable to attend the
meeting in person can register to view ACTION: Notice of public meeting;
deep vein thrombosis was reported in
a live Webcast of the meeting. You will request for comments.
the Women’s Health Initiative (WHI)
estrogen-alone substudy; and be asked to indicate in your registration
SUMMARY: The Food and Drug
(4) an increased risk of probable whether you plan to attend in person or
Administration (FDA or Agency) is
dementia in postmenopausal women 65 via the Webcast. Your registration
announcing a public meeting on the
years of age and older was reported in should also contain your complete
reauthorization of the Biosimilar User
WHI Memory Study (WHIMS) estrogen- contact information, including name,
Fee Act (BsUFA) for fiscal years (FYs)
alone ancillary study. title, affiliation, address, email address,
2018 through 2022. BsUFA authorizes
The WHI estrogen-alone studies and telephone number.
FDA to collect user fees for the process
evaluated only a single estrogen dose Seating will be limited, so early
for the review of biosimilar biological
consisting of 0.625 mg of conjugated registration is recommended.
products. The current legislative
estrogen. As lower-dose estrogen Registration is free and will be on a first-
authority for BsUFA expires in
products are now approved for the come, first-served basis. However, FDA
September 2017. At that time, new
treatment of moderate to severe may limit the number of participants
legislation will be required for FDA to
symptoms of VVA due to menopause, from each organization based on space
continue collecting user fees in future
some in the scientific/medical limitations. Registrants will receive
fiscal years. The Federal Food, Drug,
community have questioned whether confirmation once they have been
and Cosmetic Act (the FD&C Act)
these statements in the Boxed Warning accepted. Onsite registration on the day
requires that FDA begin the BsUFA
section are applicable in whole or in of the meeting will be based on space
reauthorization process by publishing a
part to the lower-dose estrogen availability. If you need special
notice in the Federal Register
products. accommodations because of disability,
requesting public input and holding a
please contact Kimberly Shiley (see FOR
II. Discussion Topics public meeting where the public may
FURTHER INFORMATION CONTACT) at least 7
The scientific workshop on November present its views on the reauthorization.
days before the meeting.
10th will include discussions of FDA will hold an open public FDA invites public comment on the
scientific challenges related to the comment session during the November BsUFA performance goals as the Agency
following topics: 10th public meeting to give the public begins the process to reauthorize the
• The relevance to lower-dose an opportunity to comment. Register for program in FYs 2018–2022.
estrogen products of the Boxed this session at DATES: The public meeting will be held
Warnings related to the WHI findings FDAVVAworkshop@fda.hhs.gov by on December 18, 2015, from 9 a.m. to 2
that: (1) Estrogens should not be used October 16, 2015. Additional p.m. Registration to attend the meeting
for the prevention of cardiovascular registration will occur at the registration must be received by November 18, 2015.
disease or dementia, (2) there is an desk on the day of the meeting on a See section III of this document for
increased risk of stroke and deep vein first-come, first-served basis if there is information on how to register for the
thrombosis in women treated with still time available during this session. meeting. Submit written or electronic
tkelley on DSK3SPTVN1PROD with NOTICES
estrogen-alone, and (3) there is an Docket Comments: Regardless of comments by January 19, 2016.
increased risk of probable dementia in attendance at the meeting, you can ADDRESSES: The meeting will be held at
postmenopausal women 65 years of age submit electronic or written comments, the FDA White Oak Campus, 10903
and older treated with estrogen-alone. including responses to the public docket New Hampshire Ave., Bldg. 31
• How to educate prescribers on the (see ADDRESSES), by October 16, 2015. Conference Center, in section B and C
interpretation of estrogen exposure data Received comments may be seen in the of the Great Room (Rm. 1503), Silver
across various estrogen dosage forms Division of Dockets Management Spring, MD 20993. Participants must
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![58260 Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices
enter through Building 1 and undergo (PDUFA) program in that it includes panels representing different
security screening. For more fees for marketing applications, stakeholder groups. We will also
information on parking and security manufacturing establishments, and provide an opportunity for other
procedures, please visit http:// products, there are some differences stakeholders to provide public comment
www.fda.gov/AboutFDA/ because of the relatively nascent state of at the meeting. FDA policy issues are
WorkingatFDA/BuildingsandFacilities/ the biosimilar industry in the United beyond the scope of these
WhiteOakCampusInformation/ States. For example, at the time BsUFA reauthorization discussions.
ucm241740.htm. was signed into law, there were no Accordingly, the comments should
Submit written comments to the currently marketed biosimilar biological focus on process enhancements and
Division of Dockets Management (HFA– products. Accordingly, BsUFA includes funding issues, and not on policy issues.
305), Food and Drug Administration, fees for products in the development
5630 Fishers Lane, Rm. 1061. Rockville, phase in order to generate fee revenue III. Meeting Attendance and
MD 20852. Submit electronic comments to support FDA’s review work during Participation
to http://www.regulations.gov. All this phase and enable sponsors to have
If you wish to attend this meeting,
comments should be identified with the meetings with FDA early in the
development of biosimilar biological visit https://fdapublicmeeting-
docket number found in brackets in the
product candidates. Additional bsufa.eventbrite.com. Please register by
heading of this document.
information concerning BsUFA, November 18, 2015. If you are unable to
Transcripts of the meeting will be
including the text of the law, the attend the meeting in person, you can
available on the FDA Web site
‘‘Biosimilar Biological Product register to view a live Webcast of the
approximately 30 days after the
meeting. Authorization Performance Goals And meeting. You will be asked to indicate
Procedures—Fiscal Years 2013 Through in your registration if you plan to attend
FOR FURTHER INFORMATION CONTACT: in person or via the Webcast. Your
2017’’ (the Commitment Letter), key
Sandra Benton, Food and Drug registration must also contain your
Federal Register documents, BsUFA-
Administration, Center for Drug complete contact information, including
related guidances, performance reports,
Evaluation and Research, 10903 New name, title, affiliation, address, email
and financial reports may be found on
Hampshire Ave., Bldg. 51, Rm. 6340, address, and phone number. Seating
the FDA Web site at http://www.fda.gov/
Silver Spring, MD 20993, 301–796– will be limited, so early registration is
forindustry/userfees/
1042, FAX: 301–847–3529, recommended. Registration is free and
biosimilaruserfeeactbsufa/default.htm.
sandra.benton@fda.hhs.gov. will be on a first-come, first-served
SUPPLEMENTARY INFORMATION: II. Purpose of Public Meeting basis. However, FDA may limit the
I. Introduction FDA is announcing a public meeting number of participants from each
on BsUFA. The authority for BsUFA organization based on space limitations.
On July 9, 2012, the Food and Drug expires at the end of September 2017. Registrants will receive confirmation
Administration Safety and Innovation Without new legislation, FDA will no once their registrations have been
Act, which included BsUFA (Pub. L. longer be able to collect user fees to accepted. Onsite registration on the day
112–144, title IV), was signed into law fund the biosimilar biological product of the meeting will be based on space
by the President. BsUFA authorizes review process. Before FDA begins availability. If you need special
FDA to collect fees for certain activities negotiations with the regulated industry accommodations because of a disability,
relating to biosimilar biological product on BsUFA reauthorization, the Agency please contact Sandra Benton (see FOR
development, for certain types of is holding the public meeting FURTHER INFORMATION CONTACT) at least 7
applications and supplements for announced in this notice, at which days before the meeting.
approval of biosimilar biological members of the public may present their
products, on establishments where In addition, any person may submit
views on reauthorization, including any written or electronic comments to the
approved biosimilar biological products suggestions for changes to the
are made, and on biosimilar biological Division of Dockets Management (see
performance goals referred to in the ADDRESSES). Comments are to be
products after approval. Commitment Letter. In addition, FDA
BsUFA’s intent is to provide identified with the docket number
will provide a period of 30 days after found in brackets in the heading of this
additional revenues so that FDA can the public meeting to obtain written
hire more staff, improve systems, and document. Received comments may be
comments from the public. The purpose seen in the Division of Dockets
establish a better managed biosimilar of this public meeting is to hear
biological product review process to Management between 9 a.m. and 4 p.m.,
stakeholder views as we consider Monday through Friday, and will be
make biosimilar biological product whether to retain, change, or
therapies available to patients sooner posted to the docket at http://
discontinue the current BsUFA www.regulations.gov. To ensure
without compromising review quality. performance goals in the next BsUFA. In
As part of FDA’s agreement with consideration, all comments must be
addition to any other relevant received by January 19, 2016.
industry during the first BsUFA information the public would like to
authorization, the Agency agreed to share, the FDA is interested in Please be advised that as soon as a
certain performance goals. These goals, responses to the following two general transcript is available, it will be
which are captured in a Commitment questions: accessible at http://www.fda.gov/
Letter, apply to the process for the • What is your assessment of the ForIndustry/UserFees/
review of biosimilar biological product overall performance of the BsUFA BiosimilarUserFeeActBsUFA/
tkelley on DSK3SPTVN1PROD with NOTICES
applications, including biosimilar program to date? UCM461774.htm.
biological product development • What aspects of BsUFA Dated: September 21, 2015.
meetings, review of applications and performance goals should be retained,
Leslie Kux,
supplements, and other review changed, or discontinued to further
activities. strengthen and improve the program? Associate Commissioner for Policy.
Although BsUFA is similar to the The meeting will likely include [FR Doc. 2015–24524 Filed 9–25–15; 8:45 am]
Prescription Drug User Fee Act presentations by FDA and a series of BILLING CODE 4164–01–P
VerDate Sep<11>2014 17:19 Sep 25, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/80_FR_58446/page/2.svg)
Document Created: 2018-02-26 10:21:38
Document Modified: 2018-02-26 10:21:38
| 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; request for comments. | |
| Dates | The public meeting will be held on December 18, 2015, from 9 a.m. to 2 p.m. Registration to attend the meeting must be received by November 18, 2015. See section III of this document for information on how to register for the meeting. Submit written or electronic comments by January 19, 2016. | |
| Contact | Sandra Benton, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796- 1042, FAX: 301-847-3529, [email protected] | |
| FR Citation | 80 FR 58259 |
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