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, 36795-36796 [2017-16580]

Download as PDF Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices mstockstill on DSK30JT082PROD with NOTICES biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human biologic product VONVENDI (von Willebrand Factor (Recombinant)). VONVENDI is indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease. Subsequent to this approval, the USPTO received patent term restoration applications for VONVENDI (U.S. Patent Nos. 6,465,624; 6,531,577; and 6,579,723) from Baxalta GmbH and Baxalta Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated September 1, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of VONVENDI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for VONVENDI is 2,690 days. Of this time, 2,335 days occurred during the testing phase of the regulatory review period, while 355 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 29, 2008. The applicants claim July 30, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was July 29, 2008, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human biological product under section VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 351 of the Public Health Service Act (42 U.S.C. 262): December 19, 2014. FDA has verified the applicant’s claim that the biologics license application (BLA) for VONVENDI (BLA 125577) was initially submitted on December 19, 2014. 3. The date the application was approved: December 8, 2015. FDA has verified the applicant’s claim that BLA 125577 was approved on December 8, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In the applications for patent extension, these applicants seek 1,521 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in 21 CFR 60.30, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–16515 Filed 8–4–17; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 36795 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. 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 oira_ submission@omb.eop.gov. 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, 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. SUMMARY: 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 E:\FR\FM\07AUN1.SGM 07AUN1 36796 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 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, & refunds for drug & biological products Number of responses per respondent Number of respondents Total annual responses Average burden per response Total hours FD&C Act sections 735 and 736 ....................................... FD&C Act section 736(d)(1)(D)(4) ..................................... Reconsideration requests .................................................. Appeal requests ................................................................. 115 25 7 1 1.3 1 1 1 150 25 7 1 16 2 24 12 2,400 50 168 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2017–16580 Filed 8–4–17; 8:45 am] [Docket No. FDA–2017–N–0001] mstockstill on DSK30JT082PROD with NOTICES BILLING CODE 4164–01–P Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, The meeting will be held on September 13, 2017, from 8:30 a.m. to 5 p.m. DATES: HHS. ACTION: VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. SUMMARY: Notice. Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36795-36796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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, 
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--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