82 FR 43241 - Biosimilar User Fee Rates for Fiscal Year 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 177 (September 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 177 (September 14, 2017)
| Page Range | 43241-43243 | |
| FR Document | 2017-19493 |
[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)] [Notices] [Pages 43241-43243] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19493] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0007] Biosimilar User Fee Rates for Fiscal Year 2018 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2017, through September 30, 2018. FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14202I, Silver Spring, MD 20993-0002, 240-402-9845. SUPPLEMENTARY INFORMATION: I. Background Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51, 379j-52, and 379j-53), as amended by BsUFA II (title IV of the FDA Reauthorization Act of 2017, Pub. L. 115-52), authorizes the program of fees for biosimilar biological products. Under section 744H(a)(1)(A) of the FD&C Act, the initial BPD fee for a product is due when the sponsor submits an investigational new drug (IND) application that FDA determines is intended to support a biosimilar biological product application or within 5 calendar days after FDA grants the first BPD meeting, whichever occurs first. A sponsor who has paid the initial BPD fee is considered to be participating in FDA's BPD program for that product. Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has paid the initial BPD fee for a product, the annual BPD fee is assessed beginning with the next fiscal year. The annual BPD fee is assessed for the product each fiscal year until the sponsor submits a marketing application for the product that is accepted for filing, or discontinues participation in FDA's BPD program. Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has discontinued participation in FDA's BPD program and wants to re-engage with FDA on development of the product, the sponsor must pay a reactivation fee to resume participation in the program. The sponsor must pay the reactivation fee by the earlier of the following dates: No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product, or upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application. The sponsor will be assessed an annual BPD fee beginning with the first fiscal year after payment of the reactivation fee. BsUFA II also authorizes fees for certain biosimilar biological product applications and for each biosimilar biological product identified in an approved biosimilar biological product application (sections 744H(a)(2) and 744H(a)(3) of the FD&C Act). Under certain conditions, FDA may grant a small business a waiver from its first biosimilar biological product application fee (section 744H(d)(1) of the FD&C Act). For FY 2018, the fee revenue amount is $45,000,000, adjusted as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications. FDA is adjusting the FY 2018 revenue amount to $40,214,000 (rounded to the nearest thousand dollars) reflecting its updated assessment of the likely workload for the BsUFA program in FY 2018. This document provides fee rates for FY 2018 for the initial and annual BPD fee ($227,213), for the reactivation fee ($454,426), for an application requiring clinical data ($1,746,745), for an application not requiring clinical data ($873,373), and for the program fee ($304,162). These fees apply to the period from October 1, 2017, through September 30, 2018. For applications that are submitted for this period, this FY 2018 fee schedule must be used. II. Fee Revenue Amount for FY 2018 The fee revenue amount for FY 2018 is $45,000,000 adjusted for updated workload estimates (see sections 744H(b)(1) and 744H(c)(4) of the FD&C Act). A. Statutory Fee Revenue Adjustments for Inflation BsUFA II specifies that the annual fee revenue amount is to be further adjusted for inflation increases for FY 2019 through FY 2022 using two separate adjustments--one for personnel [[Page 43242]] compensation and benefits (PC&B) and one for non-PC&B costs (see section 744H(c)(1) of the FD&C Act). Because the adjustment for inflation does not take effect until FY 2019, FDA will not adjust the FY 2018 fee revenue amount for inflation. B. FY 2018 Statutory Fee Revenue Adjustment for Workload BsUFA II specifies that for FY 2018, the fee revenue amount includes an adjustment to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications (see section 744H(c)(4) of the FD&C Act). In considering the appropriate FY 2018 fee revenue adjustment, FDA considered a range of factors including its best estimated level of submissions and activities (including forecasts of new BPDs, new 351(k)s, resubmitted 351(k)s, advisory committee meetings, interchangeability supplements, industry meetings, inspection activity, science and research activities, policy work, and other activities). Considering the totality of work forecasted for FY 2018 (and recognizing the inherent uncertainty of any forecast), FDA has determined that the appropriate adjusted level of the FY 2018 BsUFA fee revenue amount to be $40,214,000 (rounded to the nearest thousand dollars). FDA will use this amount as the target revenue amount for FY 2018. III. Fee Amounts for FY 2018 Under section 744H(b)(3)(A) of the FD&C Act, FDA must determine the percentage of the total revenue amount for a fiscal year to be derived from: (1) Initial and annual BPD fees and reactivation fees, (2) biosimilar biological product application fees, and (3) biosimilar biological product program fees. In establishing the fee amounts for the first year of BsUFA II, FDA considered how best to balance the fee allocation to provide stable funding and reasonable fee amounts, and utilized benchmarks as described below. In future years, FDA will consider the most appropriate means of allocating the fee amounts to collect the adjusted target revenue amount, subject to the relevant statutory provisions. A. Application Fees In establishing the biosimilar biological product application fee amount for FY 2018, FDA estimated the total number of fee-paying full applications equivalents (FAEs) it expects to receive in FY 2018. A full original 351(k) submission requiring clinical data counts as one FAE. An original 351(k) application not requiring clinical data counts as one-half of an FAE. An application that is withdrawn before filing, or refused for filing, counts as one-fourth of an FAE if the applicant initially paid a full application fee. An application that is withdrawn, or refused for filing, counts as one-eighth of an FAE if the applicant initially paid one-half of the full application fee. FDA considered the likelihood of submissions based on various indicators including a survey of sponsors on their intention to submit a 351(k) application. Based on the available information, FDA estimates it may receive 13 351(k) applications in FY 2018. FDA has determined that the amount of the biosimilar biological product application fee for FY 2018 is $1,746,745, which is estimated to provide a total of $22,707,685, representing 56 percent (rounded to the nearest one) of the FY 2018 target revenue amount. B. Biosimilar Biological Product Program Fee BsUFA II renamed the product fee as the biosimilar biological product program fee (``program fee''); in addition, BsUFA II introduced a limitation that a person who is named as an applicant in a 351(k) application shall not be assessed more than five program fees for a fiscal year for biosimilar biological products identified in each 351(k) application (see FD&C Act section 744H(a)(3)(D)). The program fee was also modified so that applicants are assessed a program fee only for biosimilar biological products identified in a biosimilar biological product application approved as of October 1 of such fiscal year. FDA estimates up to nine program fees will be invoiced in FY 2018, including currently approved products and products with the potential to be approved in pending applications with goal dates in FY 2017. For products invoiced in the FY 2018 regular billing cycle, FDA anticipates that zero program fees will be refunded. This prediction is based on observations dating to 2015, when the first biosimilar product was approved. FDA has determined that the amount of the biosimilar biological product program fee for FY 2018 is $304,162, which is estimated to provide a total of $2,737,458, representing 7 percent (rounded to the nearest one) of the FY 2018 target revenue amount. C. Initial and Annual BPD Fees, Reactivation Fees To estimate the number of participants in the BPD program in FY 2018, FDA must consider the number of new participants in the BPD program (initial BPD), the number of current participants (annual BPD), and the number of participants who will re-enter the BPD program (reactivation). FDA uses internal data, a survey of BPD sponsors, market sales data on reference products, and expected reference product expiration dates to estimate the total number of participants in the BPD program. FDA estimates 10 participants entering the BPD program, zero reactivations, and 55 participants to be invoiced for the annual BPD fee for a total of 65 participants in the BPD program in FY 2018. The remainder of the target revenue of $14,768,857, or 37 percent (rounded to the nearest one), is to be collected from the BPD fees. Dividing this amount by the estimated 65 BPD fees to be paid equals a BPD fee amount of $227,213. The reactivation fee is set at twice the initial/annual BPD amount at $454,426. FDA estimates zero reactivation fees will be paid, as none have yet been paid in the history of the BsUFA program. IV. Fee Schedule for FY 2018 The fee rates for FY 2018 are provided in table 1. Table 1--Fee Schedule for FY 2018 ------------------------------------------------------------------------ Fee rates for Fee category FY 2018 ($) ------------------------------------------------------------------------ Initial BPD............................................. 227,213 Annual BPD.............................................. 227,213 Reactivation............................................ 454,426 Applications: Requiring clinical data............................... 1,746,745 Not requiring clinical data........................... 873,373 Program................................................. 304,162 ------------------------------------------------------------------------ V. Fee Payment Options and Procedures A. Initial BPD, Reactivation, and Application Fees The fees established in the new fee schedule apply to FY 2018, i.e., the period from October 1, 2017, through September 30, 2018. The initial BPD fee for a product is due when the sponsor submits an IND that FDA determines is intended to support a biosimilar biological product application for the product or within 5 calendar days after FDA grants the first BPD meeting for the product, whichever occurs first. Sponsors who have discontinued participation in the BPD program must pay the reactivation fee by the earlier of the following dates: No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product, or upon the date of [[Page 43243]] submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application. The application fee for a biosimilar biological product is due upon submission of the application (see section 744H(a)(2)(C) of the FD&C Act). To make a payment of the initial BPD, reactivation, or application fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's Web site (http://www.fda.gov/bsufa) and generate a user fee identification (ID) number. Payment must be made in U.S. currency by electronic check, check, bank draft, U.S. postal money order, or wire transfer. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No partial payments can be made online). Once you search for your invoice, click ``Pay Now'' to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards. FDA has partnered with the U.S. Department of the Treasury to use http://www.pay.gov, a web-based payment application, for online electronic payment. The Pay.gov feature is available on FDA's Web site after completing the Biosimilar User Fee Cover Sheet and generating the user fee ID number. Please include the user fee ID number on your check, bank draft, or postal money order, and make it payable to the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. To send a check by a courier such as Federal Express or United Parcel Service, the courier must deliver the check and printed copy of the cover sheet to: U.S. Bank, ATTN: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. Contact U.S. Bank at 314-418-4013 if you have any questions concerning courier delivery.) Please make sure that the FDA post office box number (P.O. Box 979108) is written on the check, bank draft, or postal money order. If paying by wire transfer, please reference your unique user fee ID number when completing the transfer. The originating financial institution may charge a wire transfer fee. Please ask your financial institution about the fee and include it with your payment to ensure that your fee is fully paid. The account information for wire transfers is as follows: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD 20993-0002. If needed, FDA's tax identification number is 53-0196965. B. Annual BPD and Program Fees FDA will issue invoices for annual BPD and program fees for FY 2018 under the new fee schedule in September 2017. Payment instructions will be included in the invoices, including payment due dates. If sponsors join the BPD program after the annual BPD invoices have been issued in September 2017, FDA will issue invoices in December 2017 to firms subject to fees for FY 2018 that qualify for the annual BPD fee after the September 2017 billing. FDA will issue invoices in December 2017 for any annual program fees for FY 2018 that qualify for fee assessments and were not issued in September 2017. Dated: September 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-19493 Filed 9-13-17; 8:45 am] BILLING CODE 4164-01-P
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ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
ORR–5 Form ................................................................................................... 50 1 22 1,100
Estimated Total Annual Burden biological product approved in a grants the sponsor’s request for a BPD
Hours: 1,100. biosimilar biological product meeting for that product, or upon the
Additional Information: Copies of the application. date of submission by the sponsor of an
proposed collection may be obtained by BsUFA II directs FDA to establish, IND describing an investigation that
writing to the Administration for before the beginning of each fiscal year, FDA determines is intended to support
Children and Families, Office of the amount of initial and annual a biosimilar biological product
Planning, Research and Evaluation, 330 biosimilar biological product application. The sponsor will be
C Street SW., Washington, DC 20201. development (BPD) fees, the assessed an annual BPD fee beginning
Attention Reports Clearance Officer. All reactivation fee, and the biosimilar with the first fiscal year after payment
requests should be identified by the title biological product application and of the reactivation fee.
of the information collection. Email program fees for such year. These fees BsUFA II also authorizes fees for
address: infocollection@acf.hhs.gov. apply to the period from October 1, certain biosimilar biological product
OMB Comment: OMB is required to 2017, through September 30, 2018. applications and for each biosimilar
make a decision concerning the FOR FURTHER INFORMATION CONTACT: biological product identified in an
collection of information between 30 David Haas, Office of Financial approved biosimilar biological product
and 60 days after publication of this Management, Food and Drug application (sections 744H(a)(2) and
document in the Federal Register. Administration, 8455 Colesville Rd., 744H(a)(3) of the FD&C Act). Under
Therefore, a comment is best assured of COLE–14202I, Silver Spring, MD certain conditions, FDA may grant a
having its full effect if OMB receives it 20993–0002, 240–402–9845. small business a waiver from its first
within 30 days of publication. Written SUPPLEMENTARY INFORMATION: biosimilar biological product
comments and recommendations for the application fee (section 744H(d)(1) of
proposed information collection should I. Background
the FD&C Act).
be sent directly to the following: Office Sections 744G, 744H, and 744I of the For FY 2018, the fee revenue amount
of Management and Budget, Paperwork FD&C Act (21 U.S.C. 379j–51, 379j–52, is $45,000,000, adjusted as needed to
Reduction Project, Email: OIRA_ and 379j–53), as amended by BsUFA II reflect an updated assessment of the
SUBMISSION@OMB.EOP.GOV. Attn: (title IV of the FDA Reauthorization Act workload for the process for the review
Desk Officer for the Administration for of 2017, Pub. L. 115–52), authorizes the of biosimilar biological product
Children and Families program of fees for biosimilar biological applications. FDA is adjusting the FY
products. Under section 744H(a)(1)(A) 2018 revenue amount to $40,214,000
Robert Sargis,
of the FD&C Act, the initial BPD fee for (rounded to the nearest thousand
Reports Clearance Officer.
a product is due when the sponsor dollars) reflecting its updated
[FR Doc. 2017–19467 Filed 9–13–17; 8:45 am] submits an investigational new drug assessment of the likely workload for
BILLING CODE 4184–01–P (IND) application that FDA determines the BsUFA program in FY 2018.
is intended to support a biosimilar This document provides fee rates for
biological product application or within FY 2018 for the initial and annual BPD
DEPARTMENT OF HEALTH AND 5 calendar days after FDA grants the fee ($227,213), for the reactivation fee
HUMAN SERVICES first BPD meeting, whichever occurs ($454,426), for an application requiring
Food and Drug Administration first. A sponsor who has paid the initial clinical data ($1,746,745), for an
BPD fee is considered to be participating application not requiring clinical data
[Docket No. FDA–2017–N–0007] in FDA’s BPD program for that product. ($873,373), and for the program fee
Under section 744H(a)(1)(B) of the ($304,162). These fees apply to the
Biosimilar User Fee Rates for Fiscal FD&C Act, once a sponsor has paid the period from October 1, 2017, through
Year 2018 initial BPD fee for a product, the annual September 30, 2018. For applications
AGENCY: Food and Drug Administration, BPD fee is assessed beginning with the that are submitted for this period, this
HHS. next fiscal year. The annual BPD fee is FY 2018 fee schedule must be used.
ACTION: Notice. assessed for the product each fiscal year
until the sponsor submits a marketing II. Fee Revenue Amount for FY 2018
SUMMARY: The Food and Drug application for the product that is The fee revenue amount for FY 2018
Administration (FDA) is announcing the accepted for filing, or discontinues is $45,000,000 adjusted for updated
rates for biosimilar user fees for fiscal participation in FDA’s BPD program. workload estimates (see sections
year (FY) 2018. The Federal Food, Drug, Under section 744H(a)(1)(D) of the 744H(b)(1) and 744H(c)(4) of the FD&C
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and Cosmetic Act (the FD&C Act), as FD&C Act, if a sponsor has discontinued Act).
amended by the Biosimilar User Fee participation in FDA’s BPD program and
Amendments of 2017 (BsUFA II), wants to re-engage with FDA on A. Statutory Fee Revenue Adjustments
authorizes FDA to assess and collect development of the product, the sponsor for Inflation
user fees for certain activities in must pay a reactivation fee to resume BsUFA II specifies that the annual fee
connection with biosimilar biological participation in the program. The revenue amount is to be further adjusted
product development; review of certain sponsor must pay the reactivation fee by for inflation increases for FY 2019
applications for approval of biosimilar the earlier of the following dates: No through FY 2022 using two separate
biological products; and each biosimilar later than 5 calendar days after FDA adjustments—one for personnel
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submission by the sponsor of an IND If paying by wire transfer, please DATES: Fax written comments on the
describing an investigation that FDA reference your unique user fee ID collection of information by October 16,
determines is intended to support a number when completing the transfer. 2017.
biosimilar biological product The originating financial institution ADDRESSES: To ensure that comments on
application. may charge a wire transfer fee. Please the information collection are received,
The application fee for a biosimilar ask your financial institution about the OMB recommends that written
biological product is due upon fee and include it with your payment to comments be faxed to the Office of
submission of the application (see ensure that your fee is fully paid. The Information and Regulatory Affairs,
section 744H(a)(2)(C) of the FD&C Act). account information for wire transfers is OMB, Attn: FDA Desk Officer, Fax: 202–
To make a payment of the initial BPD, as follows: U.S. Department of Treasury, 395–7285, or emailed to oira_
reactivation, or application fee, TREAS NYC, 33 Liberty St., New York, submission@omb.eop.gov. All
complete the Biosimilar User Fee Cover NY 10045, Acct. No.: 75060099, Routing comments should be identified with the
Sheet, available on FDA’s Web site No.: 021030004, SWIFT: FRNYUS33, OMB control number 0910–0497. Also
(http://www.fda.gov/bsufa) and generate Beneficiary: FDA, 8455 Colesville Rd., include the FDA docket number found
a user fee identification (ID) number. 14th Floor, Silver Spring, MD 20993– in brackets in the heading of this
Payment must be made in U.S. currency 0002. If needed, FDA’s tax identification document.
by electronic check, check, bank draft, number is 53–0196965.
U.S. postal money order, or wire FOR FURTHER INFORMATION CONTACT:
transfer. The preferred payment method B. Annual BPD and Program Fees Amber Sanford, Office of Operations,
is online using electronic check Food and Drug Administration, Three
FDA will issue invoices for annual
(Automated Clearing House (ACH) also White Flint North 10A–12M, 11601
BPD and program fees for FY 2018
known as eCheck) or credit card Landsdown St., North Bethesda, MD
under the new fee schedule in
(Discover, VISA, MasterCard, American 20852, 301–796–8867, PRAStaff@
September 2017. Payment instructions
Express). Secure electronic payments fda.hhs.gov.
will be included in the invoices,
can be submitted using the User Fees including payment due dates. If SUPPLEMENTARY INFORMATION: In
Payment Portal at https:// sponsors join the BPD program after the compliance with 44 U.S.C. 3507, FDA
userfees.fda.gov/pay (Note: Only full annual BPD invoices have been issued has submitted the following proposed
payments are accepted. No partial in September 2017, FDA will issue collection of information to OMB for
payments can be made online). Once invoices in December 2017 to firms review and clearance. Focus Groups as
you search for your invoice, click ‘‘Pay subject to fees for FY 2018 that qualify Used by the Food and Drug
Now’’ to be redirected to Pay.gov. for the annual BPD fee after the Administration (All FDA-Regulated
Electronic payment options are based on September 2017 billing. FDA will issue Products), OMB Control Number 0910–
the balance due. Payment by credit card invoices in December 2017 for any 0497.
is available for balances that are less annual program fees for FY 2018 that FDA conducts voluntary focus group
than $25,000. If the balance exceeds this qualify for fee assessments and were not interviews on a variety of topics
amount, only the ACH option is issued in September 2017. involving FDA-regulated products,
available. Payments must be made using including drugs, biologics, devices,
U.S. bank accounts as well as U.S. credit Dated: September 8, 2017.
food, tobacco, and veterinary medicine.
cards. Leslie Kux, Focus groups provide an important
FDA has partnered with the U.S. Associate Commissioner for Policy. role in gathering information because
Department of the Treasury to use [FR Doc. 2017–19493 Filed 9–13–17; 8:45 am] they allow for a more in-depth
http://www.pay.gov, a web-based BILLING CODE 4164–01–P understanding of patients’ and
payment application, for online consumers’ attitudes, beliefs,
electronic payment. The Pay.gov feature motivations, and feelings than do
is available on FDA’s Web site after DEPARTMENT OF HEALTH AND quantitative studies. Focus groups serve
completing the Biosimilar User Fee HUMAN SERVICES the narrowly defined need for direct and
Cover Sheet and generating the user fee informal opinion on a specific topic and
ID number. Food and Drug Administration as a qualitative research tool have three
Please include the user fee ID number major purposes:
on your check, bank draft, or postal [Docket No. FDA–2010–N–0594]
• To obtain patient and consumer
money order, and make it payable to the information that is useful for developing
Agency Information Collection
Food and Drug Administration. Your variables and measures for quantitative
Activities; Submission for Office of
payment can be mailed to: Food and studies,
Management and Budget Review;
Drug Administration, P.O. Box 979108, • To better understand patients’ and
Comment Request; Focus Groups as
St. Louis, MO 63197–9000. To send a consumers’ attitudes and emotions in
Used by the Food and Drug
check by a courier such as Federal response to topics and concepts, and
Administration (All Food and Drug
Express or United Parcel Service, the
Administration-Regulated Products) • To further explore findings
courier must deliver the check and obtained from quantitative studies.
printed copy of the cover sheet to: U.S. AGENCY: Food and Drug Administration, FDA will use focus group findings to
Bank, ATTN: Government Lockbox HHS. test and refine their ideas, but will
asabaliauskas on DSKBBXCHB2PROD with NOTICES
979108, 1005 Convention Plaza, St. ACTION: Notice. generally conduct further research
Louis, MO 63101. (Note: This U.S. Bank before making important decisions such
address is for courier delivery only. SUMMARY: The Food and Drug as adopting new policies and allocating
Contact U.S. Bank at 314–418–4013 if Administration (FDA) is announcing or redirecting significant resources to
you have any questions concerning that a proposed collection of support these policies.
courier delivery.) Please make sure that information has been submitted to the In the Federal Register of April 21,
the FDA post office box number (P.O. Office of Management and Budget 2017 (82 FR 18763), FDA published a
Box 979108) is written on the check, (OMB) for review and clearance under 60-day notice requesting public
bank draft, or postal money order. the Paperwork Reduction Act of 1995. comment on the proposed collection of
VerDate Sep<11>2014 16:41 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1](https://thefederalregister.org/doc/82_FR_43418/page/3.svg)
Document Created: 2017-09-13 23:49:46
Document Modified: 2017-09-13 23:49:46
| 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. | |
| Dates | No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product, or upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application. The sponsor will be assessed an annual BPD fee beginning with the first fiscal year after payment of the reactivation fee. | |
| Contact | David Haas, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14202I, Silver Spring, MD 20993-0002, 240-402-9845. | |
| FR Citation | 82 FR 43241 |
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