83_FR_28973 83 FR 28853 - Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Draft Guidance for Industry; Availability

83 FR 28853 - Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 120 (June 21, 2018)

Page Range28853-28854
FR Document2018-13295

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This draft guidance is a revision of the guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,'' issued in September 2011.

Federal Register, Volume 83 Issue 120 (Thursday, June 21, 2018) 
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28853-28854]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]


Prescription Drug User Fee Act Waivers, Reductions, and Refunds 
for Drug and Biological Products; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Prescription Drug Act User Fee Waivers, Reductions, and Refunds for 
Drug and Biological Products.'' This revised draft guidance provides 
recommendations to applicants planning to request a waiver or reduction 
in user fees. This draft guidance is a revision of the guidance for 
industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug 
and Biological Products,'' issued in September 2011.

DATES: Although you can comment on any draft guidance at any time (see 
21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment 
on this draft guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the draft 
guidance by August 20, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-D-0108 for ``Prescription Drug Act User Fee Waivers, 
Reductions, and Refunds for Drug and Biological Products.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sungjoon ``Alvin'' Chi, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900, 
[email protected]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Prescription Drug User Fee Waivers, Reductions, and Refunds 
for Drug and Biological Products.'' This draft guidance provides 
recommendations to applicants regarding requests for waivers, 
reductions, or refunds of user fees assessed under sections 735 and 736 
(21 U.S.C. 379g and 379h) of the Federal Food, Drug, and Cosmetic 
(FD&C) Act. This revised draft guidance describes the types of waivers, 
reductions, and refunds permitted

[[Page 28854]]

under the user fee provisions of the FD&C Act and the procedures for 
submitting requests for waivers, reductions, refunds, and requests for 
reconsiderations or appeals. The revised draft guidance also provides 
additional clarification on certain issues such as user fee exemptions 
for orphan drugs and FDA's current thinking on considerations relevant 
to eligibility for user fee waivers, reductions, and refunds under the 
applicable statutory provisions.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Prescription 
Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological 
Products.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This draft guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party.
    The information collection of this draft guidance has been 
submitted for OMB renewal of approval under OMB control number 0910-
0693. In addition, the collection of information associated with Form 
FDA 3397 has been previously approved under OMB control number 0910-
0297. Collection of information associated with new drug application or 
biologics license applications have been previously approved under OMB 
control numbers 0910-0001 and 0910-0338, respectively. See section X of 
the draft guidance document.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13295 Filed 6-20-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28853 Dated: June 15, 2018. as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Leslie Kux, that if you include your name, contact except in accordance with 21 CFR 10.20 Associate Commissioner for Policy. information, or other information that and other applicable disclosure law. For [FR Doc. 2018–13297 Filed 6–20–18; 8:45 am] identifies you in the body of your more information about FDA’s posting BILLING CODE 4164–01–P comments, that information will be of comments to public dockets, see 80 posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • If you want to submit a comment the information at: https://www.gpo.gov/ DEPARTMENT OF HEALTH AND with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- HUMAN SERVICES do not wish to be made available to the 23389.pdf. public, submit the comment as a Docket: For access to the docket to Food and Drug Administration written/paper submission and in the read background documents or the manner detailed (see ‘‘Written/Paper electronic and written/paper comments [Docket No. FDA–2011–D–0108] Submissions’’ and ‘‘Instructions’’). received, go to https:// Prescription Drug User Fee Act Written/Paper Submissions www.regulations.gov and insert the Waivers, Reductions, and Refunds for docket number, found in brackets in the Submit written/paper submissions as heading of this document, into the Drug and Biological Products; Draft follows: Guidance for Industry; Availability ‘‘Search’’ box and follow the prompts • Mail/Hand delivery/Courier (for and/or go to the Dockets Management AGENCY: Food and Drug Administration, written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, HHS. Management Staff (HFA–305), Food and Rockville, MD 20852. Drug Administration, 5630 Fishers ACTION: Notice of availability. Submit written requests for single Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments copies of the draft guidance to the SUMMARY: The Food and Drug Division of Drug Information, Center for Administration (FDA or Agency) is submitted to the Dockets Management Staff, FDA will post your comment, as Drug Evaluation and Research, Food announcing the availability of a draft and Drug Administration, 10001 New guidance for industry entitled well as any attachments, except for information submitted, marked and Hampshire Ave., Hillandale Building, ‘‘Prescription Drug Act User Fee 4th Floor, Silver Spring, MD 20993– Waivers, Reductions, and Refunds for identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ 0002 or to the Office of Communication, Drug and Biological Products.’’ This Outreach and Development, Center for revised draft guidance provides Instructions: All submissions received must include the Docket No. FDA– Biologics Evaluation and Research, recommendations to applicants Food and Drug Administration, 10903 planning to request a waiver or 2011–D–0108 for ‘‘Prescription Drug Act User Fee Waivers, Reductions, and New Hampshire Ave., Bldg. 71, Rm. reduction in user fees. This draft 3128, Silver Spring, MD 20993–0002. guidance is a revision of the guidance Refunds for Drug and Biological Products.’’ Received comments will be Send one self-addressed adhesive label for industry entitled ‘‘User Fee Waivers, to assist the office in processing your Reductions, and Refunds for Drug and placed in the docket and, except for those submitted as ‘‘Confidential requests. See the SUPPLEMENTARY Biological Products,’’ issued in INFORMATION section for electronic September 2011. Submissions,’’ publicly viewable at https://www.regulations.gov or at the access to the draft guidance document. DATES: Although you can comment on FOR FURTHER INFORMATION CONTACT: Dockets Management Staff between 9 any draft guidance at any time (see 21 a.m. and 4 p.m., Monday through Sungjoon ‘‘Alvin’’ Chi, Center for Drug CFR 10.115(g)(5)), to ensure that the Friday. Evaluation and Research, Food and Agency considers your comment on this • Confidential Submissions—To Drug Administration, 10001 New draft guidance before it begins work on submit a comment with confidential Hampshire Ave., Rm. 2185, Silver the final version of the guidance, submit information that you do not wish to be Spring, MD 20993, 301–796–7900, either electronic or written comments made publicly available, submit your CDERCollections@fda.hhs.gov; or on the draft guidance by August 20, comments only as a written/paper Stephen Ripley, Center for Biologics 2018. submission. You should submit two Evaluation and Research, Food and ADDRESSES: You may submit comments copies total. One copy will include the Drug Administration, 10903 New as follows: information you claim to be confidential Hampshire Ave., Bldg. 71, Rm. 7301, with a heading or cover note that states Silver Spring, MD 20993–0002, 240– Electronic Submissions ‘‘THIS DOCUMENT CONTAINS 402–7911. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION: following way: Agency will review this copy, including • Federal eRulemaking Portal: the claimed confidential information, in I. Background https://www.regulations.gov. Follow the its consideration of comments. The FDA is announcing the availability of instructions for submitting comments. second copy, which will have the a draft guidance for industry entitled Comments submitted electronically, claimed confidential information ‘‘Prescription Drug User Fee Waivers, including attachments, to https:// redacted/blacked out, will be available Reductions, and Refunds for Drug and www.regulations.gov will be posted to for public viewing and posted on Biological Products.’’ This draft the docket unchanged. Because your https://www.regulations.gov. Submit guidance provides recommendations to comment will be made public, you are both copies to the Dockets Management applicants regarding requests for amozie on DSK3GDR082PROD with NOTICES1 solely responsible for ensuring that your Staff. If you do not wish your name and waivers, reductions, or refunds of user comment does not include any contact information to be made publicly fees assessed under sections 735 and confidential information that you or a available, you can provide this 736 (21 U.S.C. 379g and 379h) of the third party may not wish to be posted, information on the cover sheet and not Federal Food, Drug, and Cosmetic such as medical information, your or in the body of your comments and you (FD&C) Act. This revised draft guidance anyone else’s Social Security number, or must identify this information as describes the types of waivers, confidential business information, such ‘‘confidential.’’ Any information marked reductions, and refunds permitted VerDate Sep<11>2014 17:22 Jun 20, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1

28854 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices under the user fee provisions of the default.htm or https:// • Federal eRulemaking Portal: FD&C Act and the procedures for www.regulations.gov. https://www.regulations.gov. Follow the submitting requests for waivers, Dated: June 14, 2018. instructions for submitting comments. reductions, refunds, and requests for Leslie Kux, Comments submitted electronically, reconsiderations or appeals. The revised including attachments, to https:// Associate Commissioner for Policy. draft guidance also provides additional www.regulations.gov will be posted to [FR Doc. 2018–13295 Filed 6–20–18; 8:45 am] the docket unchanged. Because your clarification on certain issues such as user fee exemptions for orphan drugs BILLING CODE 4164–01–P comment will be made public, you are and FDA’s current thinking on solely responsible for ensuring that your considerations relevant to eligibility for comment does not include any DEPARTMENT OF HEALTH AND confidential information that you or a user fee waivers, reductions, and HUMAN SERVICES third party may not wish to be posted, refunds under the applicable statutory provisions. such as medical information, your or Food and Drug Administration This draft guidance is being issued anyone else’s Social Security number, or consistent with FDA’s good guidance confidential business information, such [Docket No. FDA 2014–D–2138] as a manufacturing process. Please note practices regulation (21 CFR 10.115). The draft guidance, when finalized, will that if you include your name, contact Agency Information Collection represent the current thinking of FDA information, or other information that Activities; Proposed Collection; identifies you in the body of your on ‘‘Prescription Drug User Fee Waivers, Comment Request; Guidance for Reductions, and Refunds for Drug and comments, that information will be Industry: Adverse Event Reporting for posted on https://www.regulations.gov. Biological Products.’’ It does not Outsourcing Facilities Under Section establish any rights for any person and • If you want to submit a comment 503B of the Federal Food, Drug, and with confidential information that you is not binding on FDA or the public. Cosmetic Act You can use an alternative approach if do not wish to be made available to the it satisfies the requirements of the AGENCY: Food and Drug Administration, public, submit the comment as a applicable statutes and regulations. This HHS. written/paper submission and in the draft guidance is not subject to manner detailed (see ‘‘Written/Paper ACTION: Notice. Executive Order 12866. Submissions’’ and ‘‘Instructions’’). SUMMARY: The Food and Drug Written/Paper Submissions II. Paperwork Reduction Act of 1995 Administration (FDA or Agency) is announcing an opportunity for public Submit written/paper submissions as Under the Paperwork Reduction Act follows: (44 U.S.C. 3501–3520), Federal Agencies comment on the proposed collection of • Mail/Hand delivery/Courier (for must obtain approval from the Office of certain information by the Agency. written/paper submissions): Dockets Management and Budget (OMB) for each Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and collection of information they conduct 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers or sponsor. ‘‘Collection of information’’ required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852. is defined in 44 U.S.C. 3502(3) and 5 Federal Register concerning each • For written/paper comments CFR 1320.3(c) and includes Agency proposed collection of information, submitted to the Dockets Management requests or requirements that members including each proposed extension of an Staff, FDA will post your comment, as of the public submit reports, keep existing collection of information and to well as any attachments, except for records, or provide information to a allow 60 days for public comment in information submitted, marked and third party. response to the notice. This notice identified, as confidential, if submitted The information collection of this solicits comments on adverse event as detailed in ‘‘Instructions.’’ draft guidance has been submitted for reporting for outsourcing facilities Instructions: All submissions received OMB renewal of approval under OMB under the Federal Food, Drug, and must include the Docket No. FDA 2014– control number 0910–0693. In addition, Cosmetic Act (FD&C Act). D–2138 for ‘‘Agency Information the collection of information associated DATES: Submit either electronic or Collection Activities; Proposed with Form FDA 3397 has been written comments on the collection of Collection; Comment Request; Guidance previously approved under OMB information by August 20, 2018. for Industry: Adverse Event Reporting control number 0910–0297. Collection ADDRESSES: You may submit comments for Outsourcing Facilities Under Section of information associated with new drug as follows. Please note that late, 503B of the Federal Food, Drug, and application or biologics license untimely filed comments will not be Cosmetic Act.’’ Received comments, applications have been previously considered. Electronic comments must those filed in a timely manner (see approved under OMB control numbers be submitted on or before August 20, ADDRESSES), will be placed in the docket 0910–0001 and 0910–0338, respectively. 2018. The https://www.regulations.gov and, except for those submitted as See section X of the draft guidance electronic filing system will accept ‘‘Confidential Submissions,’’ publicly document. comments until midnight Eastern Time viewable at https://www.regulations.gov III. Electronic Access at the end of August 20, 2018. or at the Dockets Management Staff Comments received by mail/hand between 9 a.m. and 4 p.m., Monday Persons with access to the internet delivery/courier (for written/paper through Friday. may obtain the draft guidance at either submissions) will be considered timely • Confidential Submissions—To amozie on DSK3GDR082PROD with NOTICES1 https://www.fda.gov/ if they are postmarked or the delivery submit a comment with confidential BiologicsBloodVaccines/ service acceptance receipt is on or information that you do not wish to be GuidanceCompliance before that date. made publicly available, submit your RegulatoryInformation/Guidances/ comments only as a written/paper default.htm, https://www.fda.gov/Drugs/ Electronic Submissions submission. You should submit two GuidanceCompliance Submit electronic comments in the copies total. One copy will include the RegulatoryInformation/Guidances/ following way: information you claim to be confidential VerDate Sep<11>2014 17:22 Jun 20, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1


Document Created: 2018-06-21 01:23:18
Document Modified: 2018-06-21 01:23:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough you can comment on any draft guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 20, 2018.
ContactSungjoon ``Alvin'' Chi, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900, [email protected].hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
FR Citation83 FR 28853 
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