83 FR 55370 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 214 (November 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 214 (November 5, 2018)
| Page Range | 55370-55371 | |
| FR Document | 2018-24130 |
[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)] [Notices] [Pages 55370-55371] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24130] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1967] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 5, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written [[Page 55371]] comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0718. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Biosimilars User Fee Program OMB Control Number 0910-0718--Extension This information collection supports FDA's Biosimilars User Fee Program. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), amended the Public Health Service Act by adding section 351(k) (42 U.S.C. 262(k)) to create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product (351(k) application). The BPCI Act also amended section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications as a type of application under ``human drug application'' for the purposes of the prescription drug user fee provisions. The Biosimilar User Fee Act of 2012 (BsUFA) authorized FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). BsUFA was reauthorized for an additional 5 years in August 2017 (BsUFA II). FDA's biosimilar biological product user fee program requires FDA to assess and collect user fees for certain meetings concerning biosimilar BPD (BPD meetings), investigational new drug applications (INDs) intended to support a biosimilar biological product application, and biosimilar biologic license applications (BLAs). Form FDA 3792, entitled ``Biosimilars User Fee Cover Sheet'', is submitted by each new BPD entrant (identified via a new meeting request or IND submission) and new BLAs. Form FDA 3792 requests the minimum necessary information to identify the request and determine the amount of the fee to be assessed, and to account for and track user fees. The form provides a cross-reference of the fees submitted for an activity with the actual submission or activity by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to initiate the administrative screening of biosimilar biological product INDs, and BLAs, and to account for and track user fees associated with BPD meetings. In addition to the Biosimilars User Fee Cover Sheet, the information collection includes an annual survey of all BsUFA II participants designed to provide information to FDA of anticipated BsUFA II activity in the upcoming fiscal year. This information helps FDA set appropriate annual BsUFA II fees. FDA has also developed the guidance entitled, ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017'' to assist industry in understanding when fees are incurred and the process by which applicants can submit payments. The guidance also explains how respondents can request discontinuation from the BPD program as well as how respondents can request to move products to the discontinued section of the biosimilar list. Finally, the guidance provides information on the consequences of failing to pay BsUFA II fees, as well as processes for submitting reconsideration and appeal requests. The guidance is available on our website at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf. In the Federal Register of June 29, 2018 (83 FR 30746), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden Information collection title Number of responses per Total annual per response Total hours respondents respondent responses (hours) ---------------------------------------------------------------------------------------------------------------- Biosimilar User Fee Cover Sheet; 35 1 35 * 0.5 17.5 Form FDA 3792.................. Annual Survey................... 35 1 35 1 35 Request for discontinuation from 2 1 2 1 2 BPD program.................... Request to move products to 5 1 5 * 0.5 2.5 discontinued section of the biosimilar list................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 57 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. * 30 minutes. We have increased our estimate by an additional 15 respondents since last OMB approval of the information collection. This estimated increase is based on our expectation that participation in the BPD program will continue to grow, consistent with our experience since establishment of the information collection in 2012. Dated: October 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24130 Filed 11-2-18; 8:45 am] BILLING CODE 4164-01-P
![55370 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices
considerations, including commuting give retail fuel outlets familiarity with information, how its pricing decisions
patterns, traffic flows, and outlet how their competitors price and how affect the competing location’s volumes.
characteristics. Consumers typically changing prices affect their sales. The proposed Consent Agreement
choose between nearby retail fuel Entry into each relevant market would contains additional provisions designed
outlets with similar characteristics along not be timely, likely, or sufficient to to ensure the effectiveness of the
their planned routes. The geographic deter or counteract the anticompetitive proposed relief. For example,
markets for the retail sale of diesel may effects arising from the Acquisition. Respondents have agreed to an Order to
be similar to the corresponding Significant entry barriers include the Maintain Assets that will issue at the
geographic markets for retail gasoline as availability of attractive real estate, the time the proposed Consent Agreement is
many diesel consumers exhibit the same time and cost associated with accepted for public comment. The Order
preferences and behaviors as gasoline constructing a new retail fuel outlet, and to Maintain Assets requires
consumers. the time associated with obtaining Respondents to operate and maintain
The Transaction would substantially necessary permits and approvals. each divestiture outlet in the normal
increase the market concentration in course of business, through the date the
V. The Proposed Consent Agreement
each of the five local markets, resulting Respondents’ complete divestiture of
in five highly concentrated markets for The proposed Consent Agreement the outlet. During this period, and until
the retail sale of gasoline and the retail would remedy the Acquisition’s likely such time as the buyer no longer
sale of diesel. In four of the five local anticompetitive effects by requiring requires transitional assistance, the
gasoline retail markets, the Transaction Marathon to divest certain Speedway Order to Maintain Assets authorizes the
would reduce the number of and Express Mart retail fuel outlets and Commission to appoint an independent
competitively constraining independent related assets to Sunoco in five local third party as a Monitor to oversee the
market participants from three to two. In markets. Respondents’ compliance with the
the fifth local gasoline retail market, the The proposed Consent Agreement requirements of the proposed Consent
Transaction would reduce the number requires that the divestiture be
Agreement.
of competitively constraining completed no later than 90 days after The purpose of this analysis is to
independent participants from four the Marathon consummates the Acquisition. facilitate public comment on the
three. In three of the five retail diesel This Agreement protects the proposed Consent agreement, and the
markets, the Transaction would result in Commission’s ability to obtain complete Commission does not intend this
a merger to monopoly. In the fourth and effective relief given the small analysis to constitute an official
diesel market, the Transaction would number of outlets to be divested. The interpretation of the proposed Consent
reduce the number of competitively proposed Consent Agreement further Agreement or to modify its terms in any
constraining independent participants requires Marathon and Express Mart to
way.
from three to two. In the fifth diesel maintain the economic viability,
marketability, and competitiveness of By direction of the Commission.
market, the Transaction would reduce
the number of competitively each divestiture asset until the Donald S. Clark,
constraining independent participants divestiture to Sunoco is complete. For Secretary.
from four to three. up to twelve months following the [FR Doc. 2018–24078 Filed 11–2–18; 8:45 am]
The Transaction would substantially divestiture, Marathon and Express Mart BILLING CODE 6750–01–P
lessen competition for the retail sale of must make available transitional
gasoline and the retail sale of diesel in services, as needed, to assist the buyer
these local markets. Retail fuel outlets of each divestiture asset. DEPARTMENT OF HEALTH AND
compete on price, store format, product In addition to requiring outlet HUMAN SERVICES
offerings, and location, and pay close divestitures, the proposed Consent
attention to competitors in close Agreement also requires Respondents to Food and Drug Administration
proximity, on similar traffic flows, and provide the Commission notice before
[Docket No. FDA–2018–N–1967]
with similar store characteristics. The acquiring designated outlets in the five
combined entity would be able to raise local areas for ten years. The prior Agency Information Collection
prices unilaterally in markets where notice provision is necessary because Activities; Submission for Office of
Marathon and Express Mart are close acquisitions of the designated outlets Management and Budget Review;
competitors. Absent the Transaction, likely raise competitive concerns and Comment Request; Biosimilars User
Marathon and Express Mart would may fall below the HSR Act premerger Fee Program
continue to compete head to head in notification thresholds.
these local markets. Presently, in Rochester, New York, AGENCY: Food and Drug Administration,
Moreover, the Transaction would one local market of concern, Sunoco HHS.
enhance the incentives for serves as the wholesale supplier to a ACTION: Notice.
interdependent behavior in local retail fuel outlet that is an independent
markets where only two or three competitor to Speedway and Express SUMMARY: The Food and Drug
competitively constraining independent Mart. By purchasing the Speedway Administration (FDA) is announcing
market participants would remain. Two outlet, Sunoco will also become a that a proposed collection of
aspects of the retail fuel industry make competitor to the outlet for which it is information has been submitted to the
it vulnerable to such coordination. First, currently a wholesale supplier. To Office of Management and Budget
retail fuel outlets post their fuel prices address this concern, Sunoco has agreed (OMB) for review and clearance under
on price signs that are visible from the to implement a firewall between its the Paperwork Reduction Act of 1995.
street, allowing competitors to observe wholesale and retail fuel pricing DATES: Fax written comments on the
each other’s fuel prices without businesses in that local market. The collection of information by December
difficulty. Second, retail fuel outlets firewall will restrict Sunoco retail 5, 2018.
regularly track their competitors’ fuel pricing personnel’s access to wholesale ADDRESSES: To ensure that comments on
prices and change their own prices in information, prohibiting Sunoco retail the information collection are received,
response. These repeated interactions from knowing, among other OMB recommends that written
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![Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices 55371
comments be faxed to the Office of The BPCI Act also amended section 735 product INDs, and BLAs, and to account
Information and Regulatory Affairs, of the Federal Food, Drug, and Cosmetic for and track user fees associated with
OMB, Attn: FDA Desk Officer, Fax: 202– Act (21 U.S.C. 379g) to include 351(k) BPD meetings.
395–7285, or emailed to oira_ applications as a type of application In addition to the Biosimilars User
submission@omb.eop.gov. All under ‘‘human drug application’’ for the Fee Cover Sheet, the information
comments should be identified with the purposes of the prescription drug user collection includes an annual survey of
OMB control number 0910–0718. Also fee provisions. all BsUFA II participants designed to
include the FDA docket number found The Biosimilar User Fee Act of 2012 provide information to FDA of
in brackets in the heading of this (BsUFA) authorized FDA to assess and anticipated BsUFA II activity in the
document. collect user fees for certain activities in upcoming fiscal year. This information
FOR FURTHER INFORMATION CONTACT:
connection with biosimilar biological helps FDA set appropriate annual
JonnaLynn Capezzuto, Office of product development (BPD). BsUFA BsUFA II fees.
Operations, Food and Drug was reauthorized for an additional 5 FDA has also developed the guidance
Administration, Three White Flint years in August 2017 (BsUFA II). FDA’s entitled, ‘‘Assessing User Fees Under
North, 10A–12M, 11601 Landsdown St., biosimilar biological product user fee the Biosimilar User Fee Amendments of
North Bethesda, MD 20852, 301–796– program requires FDA to assess and 2017’’ to assist industry in
3794, PRAStaff@fda.hhs.gov. collect user fees for certain meetings understanding when fees are incurred
concerning biosimilar BPD (BPD and the process by which applicants can
SUPPLEMENTARY INFORMATION: In
meetings), investigational new drug submit payments. The guidance also
compliance with 44 U.S.C. 3507, FDA applications (INDs) intended to support explains how respondents can request
has submitted the following proposed a biosimilar biological product discontinuation from the BPD program
collection of information to OMB for application, and biosimilar biologic as well as how respondents can request
review and clearance. license applications (BLAs). to move products to the discontinued
Biosimilars User Fee Program Form FDA 3792, entitled ‘‘Biosimilars section of the biosimilar list. Finally, the
User Fee Cover Sheet’’, is submitted by guidance provides information on the
OMB Control Number 0910–0718— each new BPD entrant (identified via a consequences of failing to pay BsUFA II
Extension new meeting request or IND submission) fees, as well as processes for submitting
This information collection supports and new BLAs. Form FDA 3792 requests reconsideration and appeal requests.
FDA’s Biosimilars User Fee Program. the minimum necessary information to The guidance is available on our
The Biologics Price Competition and identify the request and determine the website at https://www.fda.gov/
Innovation Act of 2009 (BPCI Act), amount of the fee to be assessed, and to downloads/Drugs/GuidanceCompliance
amended the Public Health Service Act account for and track user fees. The RegulatoryInformation/Guidances/
by adding section 351(k) (42 U.S.C. form provides a cross-reference of the UCM584984.pdf.
262(k)) to create an abbreviated fees submitted for an activity with the In the Federal Register of June 29,
approval pathway for biological actual submission or activity by using a 2018 (83 FR 30746), we published a 60-
products shown to be biosimilar to or unique number tracking system. The day notice requesting public comment
interchangeable with an FDA-licensed information collected is used by FDA’s on the proposed collection of
reference biological product. This Center for Drug Evaluation and Research information. No comments were
allows a company to apply for licensure and Center for Biologics Evaluation and received.
of a biosimilar or interchangeable Research to initiate the administrative We estimate the burden of this
biological product (351(k) application). screening of biosimilar biological collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Information Number of Number of Total burden
responses per annual per Total hours
collection title respondents respondent responses response
(hours)
Biosimilar User Fee Cover Sheet; Form FDA 3792 ............ 35 1 35 * 0.5 17.5
Annual Survey ...................................................................... 35 1 35 1 35
Request for discontinuation from BPD program .................. 2 1 2 1 2
Request to move products to discontinued section of the
biosimilar list ..................................................................... 5 1 5 * 0.5 2.5
Total .............................................................................. ........................ ........................ ........................ ........................ 57
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
We have increased our estimate by an participation in the BPD program will Dated: October 30, 2018.
additional 15 respondents since last continue to grow, consistent with our Leslie Kux,
OMB approval of the information experience since establishment of the Associate Commissioner for Policy.
collection. This estimated increase is information collection in 2012. [FR Doc. 2018–24130 Filed 11–2–18; 8:45 am]
based on our expectation that BILLING CODE 4164–01–P
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Document Created: 2018-11-03 00:28:51
Document Modified: 2018-11-03 00:28:51
| 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 | Fax written comments on the collection of information by December 5, 2018. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 83 FR 55370 |
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