82 FR 47748 - Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 197 (October 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 197 (October 13, 2017)
| Page Range | 47748-47749 | |
| FR Document | 2017-22192 |
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)] [Notices] [Pages 47748-47749] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22192] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5913] Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017 and certain proposed changes in policies and procedures surrounding its application. DATES: Submit either electronic or written comments on the draft guidance by December 12, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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-2017-D-5913 for ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Draft Guidance for Industry.'' 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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: Peter Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 240-402-8605, [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 ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.'' This draft [[Page 47749]] guidance concerns the implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and certain proposed changes in policies and procedures surrounding its application. Because PDUFA VI created significant changes to the user fee program, this draft guidance serves to provide an explanation about the new fee structure and types of fees for which applicants are responsible. PDUFA VI provides two different fee types that applicants pay: application and program fees. This draft guidance describes when these fees are incurred and the process for which applicants can submit payments. The draft guidance also provides information on consequences of failing to pay PDUFA VI fees as well as the process for submitting a reconsideration and appeals request. 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 assessing user fees under the Prescription Drug User Fee Amendments of 2017. 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 guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22192 Filed 10-12-17; 8:45 am] BILLING CODE 4164-01-P
![47748 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
Controls. Form Number: CMS–10305 comment does not include any contact information to be made publicly
(OMB control number: 0938–1115); confidential information that you or a available, you can provide this
Frequency: Yearly; Affected Public: third party may not wish to be posted, information on the cover sheet and not
Private sector (Business or other for- such as medical information, your or in the body of your comments and you
profits); Number of Respondents: 574; anyone else’s Social Security number, or must identify this information as
Total Annual Responses: 574; Total confidential business information, such ‘‘confidential.’’ Any information marked
Annual Hours: 24,050. (For policy as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
questions regarding this collection that if you include your name, contact except in accordance with 21 CFR 10.20
contact Maria Sotirelis at 410–786– information, or other information that and other applicable disclosure law. For
0552.) identifies you in the body of your more information about FDA’s posting
Dated: October 10, 2017.
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
William N. Parham, III,
• If you want to submit a comment the information at: https://www.gpo.gov/
Director, Paperwork Reduction Staff, Office with confidential information that you
of Strategic Operations and Regulatory
fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Affairs.
public, submit the comment as a Docket: For access to the docket to
[FR Doc. 2017–22207 Filed 10–12–17; 8:45 am]
written/paper submission and in the read background documents or the
BILLING CODE 4120–01–P manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
DEPARTMENT OF HEALTH AND Written/Paper Submissions www.regulations.gov and insert the
HUMAN SERVICES docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
Food and Drug Administration • Mail/Hand delivery/Courier (for
and/or go to the Dockets Management
[Docket No. FDA–2017–D–5913] written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
Assessing User Fees Under the Rockville, MD 20852.
Drug Administration, 5630 Fishers
Prescription Drug User Fee You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
Amendments of 2017; Draft Guidance • For written/paper comments guidance at any time (see 21 CFR
for Industry; Availability submitted to the Dockets Management 10.115(g)(5)).
Staff, FDA will post your comment, as Submit written requests for single
AGENCY: Food and Drug Administration, well as any attachments, except for copies of the draft guidance to the
HHS. information submitted, marked and Division of Drug Information, Center for
ACTION: Notice of availability. identified, as confidential, if submitted Drug Evaluation and Research, Food
as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
SUMMARY: The Food and Drug Hampshire Ave., Hillandale Building,
Instructions: All submissions received
Administration (FDA or Agency) is 4th Floor, Silver Spring, MD 20993–
must include the Docket No. FDA–
announcing the availability of a draft 0002; or to the Office of
2017–D–5913 for ‘‘Assessing User Fees
guidance for industry entitled Communication, Outreach and
Under the Prescription Drug User Fee
‘‘Assessing User Fees Under the Development, Center for Biologics
Amendments of 2017; Draft Guidance
Prescription Drug User Fee Evaluation and Research, Food and
for Industry.’’ Received comments will
Amendments of 2017.’’ This draft Drug Administration, 10903 New
be placed in the docket and, except for
guidance concerns FDA’s Hampshire Ave., Bldg. 71, Rm. 3128,
those submitted as ‘‘Confidential
implementation of the Prescription Drug Silver Spring, MD 20993–0002. Send
Submissions,’’ publicly viewable at
User Fee Amendments of 2017 and one self-addressed adhesive label to
https://www.regulations.gov or at the
certain proposed changes in policies assist the office in processing your
Dockets Management Staff between 9
and procedures surrounding its requests. See the SUPPLEMENTARY
a.m. and 4 p.m., Monday through
application. INFORMATION section for electronic
Friday.
DATES: Submit either electronic or • Confidential Submissions—To access to the draft guidance document.
written comments on the draft guidance submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
by December 12, 2017 to ensure that the information that you do not wish to be Peter Chen, Center for Drug Evaluation
Agency considers your comment on this made publicly available, submit your and Research, Food and Drug
draft guidance before it begins work on comments only as a written/paper Administration, 10001 New Hampshire
the final version of the guidance. submission. You should submit two Ave., Rm. 2185, Silver Spring, MD
ADDRESSES: You may submit comments copies total. One copy will include the 20993, 240–402–8605, Peter.Chen@
on any guidance at any time as follows: information you claim to be confidential fda.hhs.gov; or Stephen Ripley, Center
with a heading or cover note that states for Biologics Evaluation and Research,
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration, 10903
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The New Hampshire Ave., Bldg. 71, Rm.
following way: Agency will review this copy, including 7301, Silver Spring, MD 20993–0002,
• Federal eRulemaking Portal: 240–402–7911.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
the claimed confidential information, in
https://www.regulations.gov. Follow the its consideration of comments. The SUPPLEMENTARY INFORMATION:
instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information I. Background
including attachments, to https:// redacted/blacked out, will be available FDA is announcing the availability of
www.regulations.gov will be posted to for public viewing and posted on a draft guidance for industry entitled
the docket unchanged. Because your https://www.regulations.gov. Submit ‘‘Assessing User Fees Under the
comment will be made public, you are both copies to the Dockets Management Prescription Drug User Fee
solely responsible for ensuring that your Staff. If you do not wish your name and Amendments of 2017.’’ This draft
VerDate Sep<11>2014 18:05 Oct 12, 2017 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1](https://thefederalregister.org/doc/82_FR_47945/page/1.svg)
![Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47749
guidance concerns the implementation DEPARTMENT OF HEALTH AND Written/Paper Submissions
of the Prescription Drug User Fee HUMAN SERVICES Submit written/paper submissions as
Amendments of 2017 (PDUFA VI) and follows:
certain proposed changes in policies Food and Drug Administration • Mail/Hand delivery/Courier (for
and procedures surrounding its [Docket No. FDA–2017–D–5974] written/paper submissions): Dockets
application. Because PDUFA VI created Management Staff (HFA–305), Food and
significant changes to the user fee ‘‘Determining Whether To Submit an Drug Administration, 5630 Fishers
program, this draft guidance serves to Abbreviated New Drug Application or a Lane, Rm. 1061, Rockville, MD 20852.
provide an explanation about the new 505(b)(2) Application;’’ Draft Guidance • For written/paper comments
fee structure and types of fees for which for Industry; Availability submitted to the Dockets Management
applicants are responsible. AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as
PDUFA VI provides two different fee HHS. well as any attachments, except for
ACTION: Notice of availability. information submitted, marked and
types that applicants pay: application
identified, as confidential, if submitted
and program fees. This draft guidance
SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
describes when these fees are incurred Instructions: All submissions received
Administration (FDA or Agency) is
and the process for which applicants announcing the availability of a draft must include the Docket No. FDA–
can submit payments. The draft guidance for industry entitled 2017–D–5974 for ‘‘Determining Whether
guidance also provides information on ‘‘Determining Whether to Submit an to Submit an ANDA or a 505(b)(2)
consequences of failing to pay PDUFA ANDA or a 505(b)(2) Application.’’ This Application.’’ Received comments will
VI fees as well as the process for guidance is intended to serve as a be placed in the docket and, except for
submitting a reconsideration and foundational guidance to assist those submitted as ‘‘Confidential
appeals request. applicants in determining which one of Submissions,’’ publicly viewable at
This draft guidance is being issued the abbreviated approval pathways http://www.regulations.gov or at the
consistent with FDA’s good guidance under the Federal Food, Drug, and Dockets Management Staff between 9
practices regulation (21 CFR 10.115). Cosmetic Act (the FD&C Act) is a.m. and 4 p.m., Monday through
The draft guidance, when finalized, will appropriate for the submission of a Friday.
represent the current thinking of FDA marketing application to FDA. • Confidential Submissions—To
on assessing user fees under the DATES: Submit either electronic or submit a comment with confidential
written comments on the draft guidance information that you do not wish to be
Prescription Drug User Fee
by December 12, 2017 to ensure that the made publicly available, submit your
Amendments of 2017. It does not
Agency considers your comment on this comments only as a written/paper
establish any rights for any person and
draft guidance before it begins work on submission. You should submit two
is not binding on FDA or the public. copies total. One copy will include the
You can use an alternative approach if the final version of the guidance.
ADDRESSES: You may submit comments information you claim to be confidential
it satisfies the requirements of the with a heading or cover note that states
applicable statutes and regulations. This on any guidance at any time as follows:
‘‘THIS DOCUMENT CONTAINS
guidance is not subject to Executive Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Order 12866. Submit electronic comments in the Agency will review this copy, including
II. Electronic Access following way: the claimed confidential information, in
• Federal eRulemaking Portal: http:// its consideration of comments. The
Persons with access to the internet www.regulations.gov. Follow the second copy, which will have the
may obtain the draft guidance at either instructions for submitting comments. claimed confidential information
https://www.fda.gov/Drugs/ Comments submitted electronically, redacted/blacked out, will be available
GuidanceCompliance including attachments, to http:// for public viewing and posted on http://
RegulatoryInformation/Guidances/ www.regulations.gov will be posted to www.regulations.gov. Submit both
default.htm, https://www.fda.gov/ the docket unchanged. Because your copies to the Dockets Management Staff.
BiologicsBloodVaccines/ comment will be made public, you are If you do not wish your name and
GuidanceCompliance solely responsible for ensuring that your contact information to be made publicly
RegulatoryInformation/Guidances/ comment does not include any available, you can provide this
default.htm, or https:// confidential information that you or a information on the cover sheet and not
third party may not wish to be posted, in the body of your comments and you
www.regulations.gov.
such as medical information, your or must identify this information as
Dated: October 10, 2017. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Anna K. Abram, confidential business information, such as ‘‘confidential’’ will not be disclosed
Deputy Commissioner for Policy, Planning, as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Legislation, and Analysis. that if you include your name, contact and other applicable disclosure law. For
[FR Doc. 2017–22192 Filed 10–12–17; 8:45 am] information, or other information that more information about FDA’s posting
BILLING CODE 4164–01–P
identifies you in the body of your of comments to public dockets, see 80
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comments, that information will be FR 56469, September 18, 2015, or access
posted on http://www.regulations.gov. the information at: https://www.gpo.gov/
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
with confidential information that you 23389.pdf.
do not wish to be made available to the Docket: For access to the docket to
public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to http://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
VerDate Sep<11>2014 18:05 Oct 12, 2017 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1](https://thefederalregister.org/doc/82_FR_47945/page/2.svg)
Document Created: 2017-10-13 04:33:34
Document Modified: 2017-10-13 04:33:34
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 12, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Peter Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 240-402-8605, [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. | |
| FR Citation | 82 FR 47748 |
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