83 FR 29792 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 123 (June 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 123 (June 26, 2018)
| Page Range | 29792-29793 | |
| FR Document | 2018-13688 |
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)] [Notices] [Pages 29792-29793] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13688] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6209] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 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. [[Page 29793]] DATES: Fax written comments on the collection of information by July 26, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written 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: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 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. Guidance for Industry: Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 OMB Control Number 0910-0718--Revision This information collection supports the above captioned Agency guidance and implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II). Under BsUFA II, FDA's authority is extended to collect user fees from fiscal years 2018-2022 and includes a number of technical revisions that affect what fees and how fees are collected. Fees authorized by this legislation help fund the review process for biosimilar biological product applications and play an important role in expediting the review and approval process. We have developed the guidance document entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017'' to assist industry in understanding when these fees are incurred and the process by which applicants can submit payments. The guidance also provides information on the consequences of failing to pay BsUFA II fees, as well as processes for submitting reconsideration and appeal requests. The guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf. In the Federal Register of November 16, 2017 (82 FR 53505), we published a notice announcing availability of the subject guidance document, including a 60-day notice requesting public comment on the information collection. One comment was received in response to the notice from a trade organization indicating that interested persons ``have reviewed the draft guidance and appreciate(s) FDA applying the user fee provisions consistent with the BsUFA II negotiations and Commitment Letter.'' In addition, and upon our own review, we believe it is appropriate to include the guidance document under the existing information collection ``Biosimilar User Fee Cover Sheet'' currently approved under OMB control number 0910-0718 rather than to establish a new collection. FDA is preparing to renew OMB control number 0910-0718 and will include the guidance document accordingly. We estimate the burden of the information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden Activity Number of responses per Total annual per response Total hours respondents respondent responses (hours) ---------------------------------------------------------------------------------------------------------------- Request for discontinuation from 2 1 2 1 2 biological product development program........................ Request to move products to 5 1 5 * 0.5 2.5 discontinued section of the biosimilar list................ Small business waiver of the 1 1 1 16 16 BsUFA application fee.......... Small business waiver 1 1 1 24 24 reconsiderations............... Small business waiver appeals... 1 1 1 12 12 Annual Fee Determination Survey. 35 1 35 1 35 Annual BsUFA Fees Correspondence 35 1 35 2 70 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 161.5 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. * 30 minutes. Our estimate is based on the number of Biosimilars User Fee submissions we have received since establishing the program. Dated: June 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13688 Filed 6-25-18; 8:45 am] BILLING CODE 4164-01-P
![29792 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
information submitted, marked and Drug Administration, 10903 New speak is greater than can be reasonably
identified, as confidential, if submitted Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled
as detailed in ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may
Instructions: All submissions received 796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the
must include the Docket No. FDA– AMDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public
2018–N–1073 for ‘‘Antimicrobial Drugs Committee Information Line, 1–800– hearing session. The contact person will
Advisory Committee; Notice of Meeting; 741–8138 (301–443–0572 in the notify interested persons regarding their
Establishment of a Public Docket; Washington, DC area). A notice in the request to speak by July 5, 2018.
Request for Comments.’’ Received Federal Register about last minute Persons attending FDA’s advisory
comments, those filed in a timely modifications that impact a previously committee meetings are advised that
manner (see the ADDRESSES section), announced advisory committee meeting FDA is not responsible for providing
will be placed in the docket and, except cannot always be published quickly access to electrical outlets.
for those submitted as ‘‘Confidential enough to provide timely notice. For press inquiries, please contact the
Submissions,’’ publicly viewable at Therefore, you should always check the Office of Media Affairs at fdaoma@
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ fda.hhs.gov or 301–796–4540.
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and FDA welcomes the attendance of the
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Friday. committee meeting link, or call the meetings and will make every effort to
• Confidential Submissions—To advisory committee information line to accommodate persons with disabilities.
submit a comment with confidential learn about possible modifications If you require accommodations due to a
information that you do not wish to be before coming to the meeting. disability, please contact Kalyani Bhatt
made publicly available, submit your SUPPLEMENTARY INFORMATION: (see FOR FURTHER INFORMATION CONTACT)
comments only as a written/paper Agenda: The committee will discuss at least 7 days in advance of the
submission. You should submit two new drug application (NDA) 210607, meeting.
copies total. One copy will include the tafenoquine tablet, 100 milligram (mg), FDA is committed to the orderly
information you claim to be confidential sponsored by 60 Degrees conduct of its advisory committee
with a heading or cover note that states Pharmaceuticals, LLC, for the proposed meetings. Please visit our website at
‘‘THIS DOCUMENT CONTAINS indication of prevention of malaria in https://www.fda.gov/Advisory
CONFIDENTIAL INFORMATION.’’ FDA adults for up to 6 months of continuous Committees/AboutAdvisoryCommittees/
will review this copy, including the dosing. ucm111462.htm for procedures on
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consideration of comments. The second material available to the public no later committee meetings.
copy, which will have the claimed than 2 business days before the meeting. Notice of this meeting is given under
confidential information redacted/ If FDA is unable to post the background the Federal Advisory Committee Act (5
blacked out, will be available for public material on its website prior to the U.S.C. app. 2).
viewing and posted on https:// meeting, the background material will Dated: June 21, 2018.
www.regulations.gov. Submit both be made publicly available at the
copies to the Dockets Management Staff. Leslie Kux,
location of the advisory committee
If you do not wish your name and Associate Commissioner for Policy.
meeting, and the background material
contact information be made publicly [FR Doc. 2018–13711 Filed 6–25–18; 8:45 am]
will be posted on FDA’s website after
available, you can provide this the meeting. Background material is BILLING CODE 4164–01–P
information on the cover sheet and not available at https://www.fda.gov/
in the body of your comments and you AdvisoryCommittees/Calendar/
must identify the information as DEPARTMENT OF HEALTH AND
default.htm. Scroll down to the
‘‘confidential.’’ Any information marked HUMAN SERVICES
appropriate advisory committee meeting
as ‘‘confidential’’ will not be disclosed link. Food and Drug Administration
except in accordance with 21 CFR 10.20 Procedure: Interested persons may
and other applicable disclosure law. For present data, information, or views,
more information about FDA’s posting [Docket No. FDA–2017–D–6209]
orally or in writing, on issues pending
of comments to public dockets, see 80 before the committee. All electronic and
FR 56469, September 18, 2015, or access Agency Information Collection
written submissions submitted to the Activities; Submission for Office of
the information at: https://www.gpo.gov/ Docket (see the ADDRESSES section) on
fdsys/pkg/FR-2015-09-18/pdf/2015- Management and Budget Review;
or before July 12, 2018, will be provided Comment Request; Guidance for
23389.pdf. to the committee. Oral presentations
Docket: For access to the docket to Industry: Assessing User Fees Under
from the public will be scheduled the Biosimilar User Fee Amendments
read background documents or the between approximately 1:30 p.m. and
electronic and written/paper comments of 2017
2:30 p.m. Those individuals interested
received, go to https:// in making formal oral presentations AGENCY: Food and Drug Administration,
www.regulations.gov and insert the should notify the contact person and HHS.
docket number, found in brackets in the submit a brief statement of the general ACTION: Notice.
heading of this document, into the nature of the evidence or arguments
sradovich on DSK3GMQ082PROD with NOTICES
‘‘Search’’ box and follow the prompts they wish to present, the names and SUMMARY: The Food and Drug
and/or go to the Dockets Management addresses of proposed participants, and Administration (FDA) is announcing
Staff, 5630 Fishers Lane, Rm. 1061, an indication of the approximate time that a proposed collection of
Rockville, MD 20852. requested to make their presentation on information has been submitted to the
FOR FURTHER INFORMATION CONTACT: or before July 3, 2018. Time allotted for Office of Management and Budget
Kalyani Bhatt, Center for Drug each presentation may be limited. If the (OMB) for review and clearance under
Evaluation and Research, Food and number of registrants requesting to the Paperwork Reduction Act of 1995.
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![Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 29793
DATES: Fax written comments on the Guidance for Industry: Assessing User available on our website at: https://
collection of information by July 26, Fees Under the Biosimilar User Fee www.fda.gov/downloads/Drugs/
2018. Amendments of 2017 GuidanceComplianceRegulatory
Information/Guidances/
ADDRESSES: To ensure that comments on OMB Control Number 0910–0718—
UCM584984.pdf.
the information collection are received, Revision
In the Federal Register of November
OMB recommends that written This information collection supports
16, 2017 (82 FR 53505), we published a
comments be faxed to the Office of the above captioned Agency guidance
notice announcing availability of the
Information and Regulatory Affairs, and implementation of the Biosimilar
subject guidance document, including a
OMB, Attn: FDA Desk Officer, Fax: 202– User Fee Amendments of 2017 (BsUFA
60-day notice requesting public
395–7285, or emailed to oira_ II). Under BsUFA II, FDA’s authority is
comment on the information collection.
submission@omb.eop.gov. All extended to collect user fees from fiscal
One comment was received in response
comments should be identified with the years 2018–2022 and includes a number
to the notice from a trade organization
of technical revisions that affect what
OMB control number 0910–0718. Also indicating that interested persons ‘‘have
fees and how fees are collected. Fees
include the FDA docket number found reviewed the draft guidance and
authorized by this legislation help fund
in brackets in the heading of this the review process for biosimilar appreciate(s) FDA applying the user fee
document. biological product applications and play provisions consistent with the BsUFA II
an important role in expediting the negotiations and Commitment Letter.’’
FOR FURTHER INFORMATION CONTACT: In addition, and upon our own review,
Domini Bean, Office of Operations, review and approval process.
We have developed the guidance we believe it is appropriate to include
Food and Drug Administration, Three the guidance document under the
document entitled ‘‘Assessing User Fees
White Flint North, 10A–12M, 11601 Under the Biosimilar User Fee existing information collection
Landsdown St., North Bethesda, MD Amendments of 2017’’ to assist industry ‘‘Biosimilar User Fee Cover Sheet’’
20852, 301–796–5733, PRAStaff@ in understanding when these fees are currently approved under OMB control
fda.hhs.gov. incurred and the process by which number 0910–0718 rather than to
applicants can submit payments. The establish a new collection. FDA is
SUPPLEMENTARY INFORMATION: In preparing to renew OMB control
guidance also provides information on
compliance with 44 U.S.C. 3507, FDA number 0910–0718 and will include the
the consequences of failing to pay
has submitted the following proposed guidance document accordingly.
BsUFA II fees, as well as processes for
collection of information to OMB for submitting reconsideration and appeal We estimate the burden of the
review and clearance. requests. The guidance document is information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
Activity responses per Total hours
respondents responses response
respondent (hours)
Request for discontinuation from biological product devel-
opment program ............................................................... 2 1 2 1 2
Request to move products to discontinued section of the
biosimilar list ..................................................................... 5 1 5 * 0.5 2.5
Small business waiver of the BsUFA application fee .......... 1 1 1 16 16
Small business waiver reconsiderations .............................. 1 1 1 24 24
Small business waiver appeals ........................................... 1 1 1 12 12
Annual Fee Determination Survey ....................................... 35 1 35 1 35
Annual BsUFA Fees Correspondence ................................ 35 1 35 2 70
Total .............................................................................. ........................ ........................ ........................ ........................ 161.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Our estimate is based on the number DEPARTMENT OF HEALTH AND Program (the Program), as required by
of Biosimilars User Fee submissions we HUMAN SERVICES the Public Health Service (PHS) Act, as
have received since establishing the amended. While the Secretary of HHS is
program. Health Resources and Services named as the respondent in all
Administration proceedings brought by the filing of
Dated: June 21, 2018.
petitions for compensation under the
Leslie Kux, National Vaccine Injury Compensation
Program, the United States Court of
Associate Commissioner for Policy. Program; List of Petitions Received
Federal Claims is charged by statute
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2018–13688 Filed 6–25–18; 8:45 am] AGENCY: Health Resources and Services with responsibility for considering and
BILLING CODE 4164–01–P Administration (HRSA), Department of acting upon the petitions.
Health and Human Services (HHS).
FOR FURTHER INFORMATION CONTACT: For
ACTION: Notice.
information about requirements for
SUMMARY: HRSA is publishing this filing petitions and the Program in
notice of petitions received under the general, contact Lisa L. Reyes, Clerk of
National Vaccine Injury Compensation Court, United States Court of Federal
VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1](https://thefederalregister.org/doc/83_FR_29915/page/2.svg)
Document Created: 2018-06-26 00:51:51
Document Modified: 2018-06-26 00:51:51
| 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 July 26, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 29792 |
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