82 FR 36795 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

Page Range		36795-36796
FR Document		2017-16580

The Food and Drug Administration (FDA, Agency or we) 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.

Federal Register, Volume 82 Issue 150 (Monday, August 7, 2017)

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36795-36796]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0222]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry--User Fee Waivers, Reductions, and Refunds for Drug and 
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency or we) 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 
September 6, 2017.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0693. 
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, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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--User Fee Waivers, Reductions, and Refunds for 
Drug and Biological Products OMB Control Number 0910-0693--Extension

    The guidance provides recommendations for applicants planning to 
request waivers or reductions in prescription drug user fees assessed 
under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). The guidance 
describes the types of waivers and reductions permitted under the 
prescription drug

[[Page 36796]]

user fee provisions of the FD&C Act, and the procedures for submitting 
requests for waivers or reductions. It also includes recommendations 
for submitting information for requests for reconsideration of denials 
of waiver or reduction requests, and for requests for appeals. The 
guidance also provides clarification on related issues such as user fee 
exemptions for orphan drugs.
    Based on Agency records, we estimate that the total annual number 
of waiver requests submitted for all of these categories will be 150, 
submitted by 115 different applicants. We estimate that the average 
burden hours for preparation of a submission will total 16 hours. 
Because FDA may request additional information from the applicant 
during the review period, we have also included in this estimate time 
to prepare any additional information. We have included in the burden 
estimate the preparation and submission of application fee waivers for 
small businesses, because small businesses requesting a waiver must 
submit documentation to FDA on the number of their employees and must 
include the information that the application is the first human drug 
application, within the meaning of the FD&C Act, to be submitted to the 
Agency for approval.
    Previously, after receipt of a small business waiver request, FDA 
would request a small business size determination from the Small 
Business Administration (SBA). Waiver applicants would submit their 
supporting documentation directly to SBA for evaluation and after 
completing their review, SBA provided FDA with a determination whether 
a waiver applicant qualified as a small business for purposes of 
evaluating user fee waivers. The burden for submission of this 
information to SBA is approved under OMB control number 3245-0101.
    Beginning fiscal year 2015, the SBA declined to conduct further 
size determinations for evaluation of small business user fee waivers 
and as a result, a processing change at FDA occurred. The new FDA 
process requires waiver applicants to submit documentation directly to 
FDA. In addition, fewer supporting documents than previously requested 
by SBA are required. As a result, we estimate that the 4 burden hours 
per small business waiver previously attributed to SBA and approved 
under OMB control number 3245-0101, should now be attributed to FDA 
because SBA is no longer conducting size determinations for FDA. Also, 
because FDA is asking that applicants submit fewer supporting 
documents, we estimate that these burden hours should be reduced to 2 
hours instead of 4 hours. We understand that SBA plans to submit a 
revised burden estimate to OMB control number 3245-0101 to account for 
this redistribution.
    The reconsideration and appeal requests are not addressed in the 
FD&C Act, but are discussed in the guidance. We estimate that we will 
receive seven requests for reconsideration annually, and that the total 
average burden hours for a reconsideration request will be 24 hours. In 
addition, we estimate that we will receive one request annually for an 
appeal of a user fee waiver determination, and that the time needed to 
prepare an appeal would be approximately 12 hours. We have included in 
this estimate both the time needed to prepare the request for appeal to 
the Chief Scientist, User Fee Appeals Officer, Office of the 
Commissioner, and the time needed to create and send a copy of the 
request for an appeal to the Director, Division of User Fee Management, 
Office of Management, Center for Drug Evaluation and Research.
    The burden for completing and submitting Form FDA 3397 
(Prescription Drug User Fee Coversheet) is not included in this 
analysis as the burden is included under OMB control number 0910-0297. 
The collections of information associated with submission of a new drug 
application or biologics license application are approved under OMB 
control numbers 0910-0001 and 0910-0338, respectively.
    In the Federal Register of May 23, 2017 (82 FR 23581), FDA 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
User fee waivers, reductions, &                     Number of                         Average
 refunds for  drug & biological     Number of     responses per    Total annual     burden per      Total hours
            products               respondents      respondent       responses       response
----------------------------------------------------------------------------------------------------------------
FD&C Act sections 735 and 736..             115              1.3             150              16           2,400
FD&C Act section                             25                1              25               2              50
 736(d)(1)(D)(4)...............
Reconsideration requests.......               7                1               7              24             168
Appeal requests................               1                1               1              12              12
                                --------------------------------------------------------------------------------
Total..........................  ..............  ...............  ..............  ..............           2,630
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16580 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36795

biological product becomes effective 351 of the Public Health Service Act (42 DEPARTMENT OF HEALTH AND
and runs until the approval phase U.S.C. 262): December 19, 2014. FDA HUMAN SERVICES
begins. The approval phase starts with has verified the applicant’s claim that
the initial submission of an application the biologics license application (BLA) Food and Drug Administration
to market the human biological product for VONVENDI (BLA 125577) was [Docket No. FDA–2014–N–0222]
and continues until FDA grants initially submitted on December 19,
permission to market the biological 2014. Agency Information Collection
product. Although only a portion of a Activities; Submission for Office of
regulatory review period may count 3. The date the application was
Management and Budget Review;
toward the actual amount of extension approved: December 8, 2015. FDA has
Comment Request; Guidance for
that the Director of USPTO may award verified the applicant’s claim that BLA
Industry—User Fee Waivers,
(for example, half the testing phase must 125577 was approved on December 8,
Reductions, and Refunds for Drug and
be subtracted as well as any time that 2015. Biological Products
may have occurred before the patent This determination of the regulatory
was issued), FDA’s determination of the review period establishes the maximum AGENCY: Food and Drug Administration,
length of a regulatory review period for HHS.
potential length of a patent extension.
a human biological product will include However, the USPTO applies several ACTION: Notice.
all of the testing phase and approval statutory limitations in its calculations
phase as specified in 35 U.S.C. SUMMARY: The Food and Drug
of the actual period for patent extension. Administration (FDA, Agency or we) is
156(g)(1)(B).
In the applications for patent extension, announcing that a proposed collection
FDA has approved for marketing the
human biologic product VONVENDI these applicants seek 1,521 days of of information has been submitted to the
(von Willebrand Factor (Recombinant)). patent term extension. Office of Management and Budget
VONVENDI is indicated for on-demand (OMB) for review and clearance under
III. Petitions
treatment and control of bleeding the Paperwork Reduction Act of 1995.
episodes in adults diagnosed with von Anyone with knowledge that any of DATES: Fax written comments on the
Willebrand disease. Subsequent to this the dates as published are incorrect may collection of information by September
approval, the USPTO received patent submit either electronic or written 6, 2017.
term restoration applications for comments and, under 21 CFR 60.24, ask ADDRESSES: To ensure that comments on
VONVENDI (U.S. Patent Nos. 6,465,624; for a redetermination (see DATES). the information collection are received,
6,531,577; and 6,579,723) from Baxalta Furthermore, as specified in 21 CFR OMB recommends that written
GmbH and Baxalta Inc., and the USPTO 60.30, any interested person may comments be faxed to the Office of
requested FDA’s assistance in petition FDA for a determination Information and Regulatory Affairs,
determining the patents’ eligibility for regarding whether the applicant for OMB, Attn: FDA Desk Officer, FAX:
patent term restoration. In a letter dated extension acted with due diligence 202–395–7285, or emailed to oira_
September 1, 2016, FDA advised the submission@omb.eop.gov. All
during the regulatory review period. To
USPTO that this human biological comments should be identified with the
meet its burden, the petition must be
product had undergone a regulatory OMB control number 0910–0693. Also
review period and that the approval of timely (see DATES) and contain sufficient
include the FDA docket number found
VONVENDI represented the first facts to merit an FDA investigation. (See
in brackets in the heading of this
permitted commercial marketing or use H. Rept. 857, part 1, 98th Cong., 2d
document.
of the product. Thereafter, the USPTO sess., pp. 41–42, 1984.) Petitions should
be in the format specified in 21 CFR FOR FURTHER INFORMATION CONTACT:
requested that FDA determine the
10.30. Domini Bean, Office of Operations,
product’s regulatory review period.
Food and Drug Administration, Three
II. Determination of Regulatory Review Submit petitions electronically to White Flint North, 10A63, 11601
Period https://www.regulations.gov at Docket Landsdown St., North Bethesda, MD
No. FDA–2013–S–0610. Submit written 20852, 301–796–5733, PRAStaff@
FDA has determined that the petitions (two copies are required) to the
applicable regulatory review period for fda.hhs.gov.
Dockets Management Staff (HFA–305),
VONVENDI is 2,690 days. Of this time, SUPPLEMENTARY INFORMATION: In
Food and Drug Administration, 5630
2,335 days occurred during the testing compliance with 44 U.S.C. 3507, FDA
Fishers Lane, Rm. 1061, Rockville, MD
phase of the regulatory review period, has submitted the following proposed
while 355 days occurred during the 20852. collection of information to OMB for
approval phase. These periods of time Dated: August 1, 2017. review and clearance.
were derived from the following dates: Anna K. Abram,
1. The date an exemption under Guidance for Industry—User Fee
Deputy Commissioner for Policy, Planning, Waivers, Reductions, and Refunds for
section 505(i) of the Federal Food, Drug, Legislation, and Analysis.
and Cosmetic Act (21 U.S.C. 355(i)) Drug and Biological Products OMB
[FR Doc. 2017–16515 Filed 8–4–17; 8:45 am] Control Number 0910–0693—Extension
became effective: July 29, 2008. The
BILLING CODE 4164–01–P The guidance provides
applicants claim July 30, 2008, as the
date the investigational new drug recommendations for applicants
application (IND) became effective. planning to request waivers or
mstockstill on DSK30JT082PROD with NOTICES

However, FDA records indicate that the reductions in prescription drug user fees
IND effective date was July 29, 2008, assessed under sections 735 and 736 of
which was 30 days after FDA receipt of the Federal Food, Drug, and Cosmetic
the IND. Act (21 U.S.C. 379g and 21 U.S.C. 379h)
2. The date the application was (the FD&C Act). The guidance describes
initially submitted with respect to the the types of waivers and reductions
human biological product under section permitted under the prescription drug

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36796 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices

user fee provisions of the FD&C Act, and supporting documentation directly to requests for reconsideration annually,
the procedures for submitting requests SBA for evaluation and after completing and that the total average burden hours
for waivers or reductions. It also their review, SBA provided FDA with a for a reconsideration request will be 24
includes recommendations for determination whether a waiver hours. In addition, we estimate that we
submitting information for requests for applicant qualified as a small business will receive one request annually for an
reconsideration of denials of waiver or for purposes of evaluating user fee appeal of a user fee waiver
reduction requests, and for requests for waivers. The burden for submission of determination, and that the time needed
appeals. The guidance also provides this information to SBA is approved to prepare an appeal would be
clarification on related issues such as under OMB control number 3245–0101. approximately 12 hours. We have
user fee exemptions for orphan drugs. Beginning fiscal year 2015, the SBA included in this estimate both the time
Based on Agency records, we estimate declined to conduct further size needed to prepare the request for appeal
that the total annual number of waiver determinations for evaluation of small to the Chief Scientist, User Fee Appeals
requests submitted for all of these business user fee waivers and as a Officer, Office of the Commissioner, and
categories will be 150, submitted by 115 result, a processing change at FDA the time needed to create and send a
different applicants. We estimate that occurred. The new FDA process copy of the request for an appeal to the
the average burden hours for requires waiver applicants to submit Director, Division of User Fee
preparation of a submission will total 16 documentation directly to FDA. In Management, Office of Management,
hours. Because FDA may request addition, fewer supporting documents Center for Drug Evaluation and
additional information from the than previously requested by SBA are Research.
applicant during the review period, we required. As a result, we estimate that
The burden for completing and
have also included in this estimate time the 4 burden hours per small business
submitting Form FDA 3397
to prepare any additional information. waiver previously attributed to SBA and
(Prescription Drug User Fee Coversheet)
We have included in the burden approved under OMB control number
is not included in this analysis as the
estimate the preparation and submission 3245–0101, should now be attributed to
burden is included under OMB control
of application fee waivers for small FDA because SBA is no longer
number 0910–0297. The collections of
businesses, because small businesses conducting size determinations for FDA.
information associated with submission
requesting a waiver must submit Also, because FDA is asking that
of a new drug application or biologics
documentation to FDA on the number of applicants submit fewer supporting
license application are approved under
their employees and must include the documents, we estimate that these
OMB control numbers 0910–0001 and
information that the application is the burden hours should be reduced to 2
0910–0338, respectively.
first human drug application, within the hours instead of 4 hours. We understand
meaning of the FD&C Act, to be that SBA plans to submit a revised In the Federal Register of May 23,
submitted to the Agency for approval. burden estimate to OMB control number 2017 (82 FR 23581), FDA published a
Previously, after receipt of a small 3245–0101 to account for this 60-day notice requesting public
business waiver request, FDA would redistribution. comment on the proposed extension of
request a small business size The reconsideration and appeal this collection of information. No
determination from the Small Business requests are not addressed in the FD&C comments were received.
Administration (SBA). Waiver Act, but are discussed in the guidance. FDA estimates the burden of this
applicants would submit their We estimate that we will receive seven collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
User fee waivers, reductions, & refunds for Number of Total annual
responses per burden per Total hours
drug & biological products respondents responses
respondent response

FD&C Act sections 735 and 736 ....................................... 115 1.3 150 16 2,400
FD&C Act section 736(d)(1)(D)(4) ..................................... 25 1 25 2 50
Reconsideration requests .................................................. 7 1 7 24 168
Appeal requests ................................................................. 1 1 1 12 12

Total ................................................................................... ........................ .......................... ........................ ........................ 2,630
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: August 2, 2017. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Anna K. Abram, HUMAN SERVICES Administration (FDA or the Agency)
Deputy Commissioner for Policy, Planning, announces a forthcoming public
Legislation, and Analysis. Food and Drug Administration advisory committee meeting of the
[FR Doc. 2017–16580 Filed 8–4–17; 8:45 am] Vaccines and Related Biological
BILLING CODE 4164–01–P
[Docket No. FDA–2017–N–0001] Products Advisory Committee
(VRBPAC). The general function of the
Vaccines and Related Biological
mstockstill on DSK30JT082PROD with NOTICES

committee is to provide advice and
Products Advisory Committee; Notice recommendations to the Agency on
of Meeting FDA’s regulatory issues. The meeting
will be open to the public.
AGENCY: Food and Drug Administration,
HHS. DATES: The meeting will be held on
September 13, 2017, from 8:30 a.m. to
ACTION: Notice.
5 p.m.

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Document Created: 2017-08-05 03:00:21
Document Modified: 2017-08-05 03:00:21

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 September 6, 2017.
Contact		Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation		82 FR 36795

82 FR 36795 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration