82 FR 61763 - Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 249 (December 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 249 (December 29, 2017)
| Page Range | 61763-61764 | |
| FR Document | 2017-28140 |
[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)] [Notices] [Pages 61763-61764] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28140] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6530] Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (hereafter referred to as products). The previous guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009, and the draft guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' published March 11, 2015, have been withdrawn. DATES: Submit either electronic or written comments on the draft guidance by March 29, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-6530 for ``Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability.'' 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, [[Page 61764]] 4th Floor, Silver Spring, MD 20993-0002, or 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Rachel B. Kichline, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301- 796-0319; 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 ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. This draft guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only). This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing for, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible. The previous guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009, and the draft guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' published March 11, 2015, have been withdrawn. 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 formal meetings between FDA and sponsors or applicants of PDUFA 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 guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information referred to in the guidance entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' have been approved under OMB control number 0910-0429. The collections of information for Form FDA 1571 and end-of-phase 2 meetings have been approved under OMB control number 0910-0014 and collections of information for Form FDA 356h have been approved under OMB control number 0910-0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: December 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-28140 Filed 12-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 61763
Advantage and Prescription Drug Plan products (hereafter referred to as 2017–D–6530 for ‘‘Formal Meetings
organizations submit a completed PBP products). The previous guidance for Between the Food and Drug
and formulary as part of the annual industry ‘‘Formal Meetings Between the Administration and Sponsors or
bidding process. During this process, FDA and Sponsors or Applicants’’ Applicants of Prescription Drug User
organizations prepare their proposed published May 19, 2009, and the draft Fee Act Products; Draft Guidance for
plan benefit packages for the upcoming guidance for industry ‘‘Formal Meetings Industry; Availability.’’ Received
contract year and submit them to us for Between the FDA and Sponsors or comments will be placed in the docket
review and approval. We publish Applicants of PDUFA Products’’ and, except for those submitted as
beneficiary education information using published March 11, 2015, have been ‘‘Confidential Submissions,’’ publicly
a variety of formats. The specific withdrawn. viewable at https://www.regulations.gov
education initiatives that utilize PBP or at the Dockets Management Staff
DATES: Submit either electronic or
and formulary data include web between 9 a.m. and 4 p.m., Monday
written comments on the draft guidance
application tools on www.medicare.gov through Friday.
by March 29, 2018 to ensure that the • Confidential Submissions—To
and the plan benefit insert in the
Agency considers your comment on this submit a comment with confidential
Medicare & You handbook. In addition,
draft guidance before it begins work on information that you do not wish to be
organizations utilize the PBP data to
the final version of the guidance. made publicly available, submit your
generate their Summary of Benefits
marketing information. ADDRESSES: You may submit comments comments only as a written/paper
This notice replaces the 30-day on any guidance at any time as follows: submission. You should submit two
Federal Register notice that published Electronic Submissions copies total. One copy will include the
on December 13, 2017 (82 FR 58613) information you claim to be confidential
which was subsequently withdrawn on Submit electronic comments in the with a heading or cover note that states
December 22, 2017 (82 FR 60744). following way: ‘‘THIS DOCUMENT CONTAINS
Form Number: CMS–R–262 (OMB • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
control number 0938–0763); Frequency: https://www.regulations.gov. Follow the Agency will review this copy, including
Yearly; Affected Public: Private sector instructions for submitting comments. the claimed confidential information, in
(Business or other for-profits and Not- Comments submitted electronically, its consideration of comments. The
for-profit institutions); Number of including attachments, to https:// second copy, which will have the
Respondents: 520; Total Annual www.regulations.gov will be posted to claimed confidential information
Responses: 5,675; Total Annual Hours: the docket unchanged. Because your redacted/blacked out, will be available
56,450. (For policy questions regarding comment will be made public, you are for public viewing and posted on
this collection contact Kristy Holtje at solely responsible for ensuring that your https://www.regulations.gov. Submit
410–786–2209.) comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
Dated: December 26, 2017.
third party may not wish to be posted, contact information to be made publicly
William N. Parham, III, such as medical information, your or available, you can provide this
Director, Paperwork Reduction Staff, Office anyone else’s Social Security number, or information on the cover sheet and not
of Strategic Operations and Regulatory confidential business information, such
Affairs. in the body of your comments and you
as a manufacturing process. Please note must identify this information as
[FR Doc. 2017–28159 Filed 12–28–17; 8:45 am]
that if you include your name, contact ‘‘confidential.’’ Any information marked
BILLING CODE 4120–01–P information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
comments, that information will be and other applicable disclosure law. For
DEPARTMENT OF HEALTH AND
posted on https://www.regulations.gov. more information about FDA’s posting
HUMAN SERVICES • If you want to submit a comment of comments to public dockets, see 80
Food and Drug Administration with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
[Docket No. FDA–2017–D–6530] public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
Formal Meetings Between the Food manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
and Drug Administration and Sponsors Submissions’’ and ‘‘Instructions’’). read background documents or the
or Applicants of Prescription Drug electronic and written/paper comments
User Fee Act Products; Draft Guidance Written/Paper Submissions
received, go to https://
for Industry; Availability Submit written/paper submissions as www.regulations.gov and insert the
AGENCY: Food and Drug Administration, follows: docket number, found in brackets in the
HHS. • Mail/Hand delivery/Courier (for heading of this document, into the
ACTION: Notice of availability. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
announcing the availability of a draft • For written/paper comments You may submit comments on any
guidance for industry entitled ‘‘Formal submitted to the Dockets Management guidance at any time (see 21 CFR
ethrower on DSK3G9T082PROD with NOTICES
Meetings Between the FDA and Staff, FDA will post your comment, as 10.115(g)(5)).
Sponsors or Applicants of PDUFA well as any attachments, except for Submit written requests for single
Products.’’ This draft guidance provides information submitted, marked and copies of the draft guidance to the
recommendations to industry on formal identified, as confidential, if submitted Division of Drug Information, Center for
meetings between FDA and sponsors or as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food
applicants relating to the development Instructions: All submissions received and Drug Administration, 10001 New
and review of drug or biological must include the Docket No. FDA– Hampshire Ave., Hillandale Building,
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![61764 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices
4th Floor, Silver Spring, MD 20993– PDUFA Products’’ published March 11, ACTION: Notice of availability.
0002, or Office of Communication, 2015, have been withdrawn.
Outreach, and Development, Center for This draft guidance is being issued SUMMARY: The Food and Drug
Biologics Evaluation and Research, consistent with FDA’s good guidance Administration (FDA or Agency) is
Food and Drug Administration, 10903 practices regulation (21 CFR 10.115). announcing the availability of a
New Hampshire Ave., Bldg. 71, Rm. The draft guidance, when finalized, will guidance for industry and review staff
3128, Silver Spring, MD 20993–0002. represent the current thinking of FDA entitled ‘‘Best Practices for
Send one self-addressed adhesive label on formal meetings between FDA and Communication Between IND Sponsors
to assist that office in processing your sponsors or applicants of PDUFA and FDA During Drug Development.’’
requests. See the SUPPLEMENTARY products. It does not establish any rights Timely, transparent, and effective
INFORMATION section for electronic for any person and is not binding on communications between
FDA or the public. You can use an investigational new drug application
access to the draft guidance document.
alternative approach if it satisfies the (IND) sponsors and FDA at critical
FOR FURTHER INFORMATION CONTACT: junctures in drug development facilitate
requirements of the applicable statutes
Rachel B. Kichline, Center for Drug and regulations. This guidance is not earlier availability of safe and effective
Evaluation and Research, Food and subject to Executive Order 12866. drugs to the American public. This
Drug Administration, 10903 New guidance describes FDA’s philosophy
Hampshire Ave., Bldg. 22, Rm. 6312, II. The Paperwork Reduction Act of regarding timely interactive
Silver Spring, MD 20993–0002, 301– 1995 communication with IND sponsors as a
796–0319; or Stephen Ripley, Center for This draft guidance refers to core activity; describes the scope of
Biologics Evaluation and Research, previously approved collections of appropriate interactions between FDA
Food and Drug Administration, 10903 information that are subject to review by review teams and IND sponsors;
New Hampshire Ave., Bldg. 71, Rm. the Office of Management and Budget outlines the types of advice appropriate
7301, Silver Spring, MD 20993–0002, (OMB) under the Paperwork Reduction for sponsors to seek from FDA in
240–402–7911. Act of 1995 (44 U.S.C. 3501–3520). The pursuing their drug development
SUPPLEMENTARY INFORMATION: collections of information referred to in programs; describes the general
the guidance entitled ‘‘Formal Meetings expectations for the timing of FDA
I. Background Between the FDA and Sponsors or responses to IND sponsor inquiries;
Applicants’’ have been approved under describes best practices and
FDA is announcing the availability of
OMB control number 0910–0429. The communication methods to facilitate
a draft guidance for industry entitled
collections of information for Form FDA interactions between FDA review teams
‘‘Formal Meetings Between the FDA and
1571 and end-of-phase 2 meetings have and IND sponsors during drug
Sponsors or Applicants of PDUFA
been approved under OMB control development; and includes expectations
Products.’’ This draft guidance provides
number 0910–0014 and collections of on appropriate methods and frequency
recommendations to industry on formal
information for Form FDA 356h have of such communications. This guidance
meetings between FDA and sponsors or
been approved under OMB control does not apply to communications or
applicants relating to the development
number 0910–0338. inquiries from industry trade
and review of products regulated by the organizations, consumer or patient
Center for Drug Evaluation and Research III. Electronic Access advocacy organizations, other
and the Center for Biologics Evaluation Persons with access to the internet government agencies, or other
and Research. This draft guidance does may obtain the draft guidance at https:// stakeholders not pursuing a
not apply to abbreviated new drug www.fda.gov/Drugs/Guidance development program under an IND.
applications, applications for biosimilar ComplianceRegulatoryInformation/ This guidance finalizes the draft
biological products, or submissions for Guidances/default.htm, https:// guidance issued on December 9, 2015.
medical devices. For the purposes of www.fda.gov/BiologicsBloodVaccines/ DATES: The announcement of the
this guidance, formal meeting includes GuidanceComplianceRegulatory guidance is published in the Federal
any meeting that is requested by a Information/default.htm, or https:// Register on December 29, 2017.
sponsor or applicant following the www.regulations.gov.
request procedures provided in this ADDRESSES: You may submit either
guidance and includes meetings Dated: December 19, 2017. electronic or written comments on
conducted in any format (i.e., face to Leslie Kux, Agency guidances at any time as
face, teleconference/videoconference, or Associate Commissioner for Policy. follows:
written response only). [FR Doc. 2017–28140 Filed 12–28–17; 8:45 am] Electronic Submissions
This guidance discusses the BILLING CODE 4164–01–P
Submit electronic comments in the
principles of good meeting management following way:
practices and describes standardized • Federal eRulemaking Portal:
procedures for requesting, preparing for, DEPARTMENT OF HEALTH AND
https://www.regulations.gov. Follow the
scheduling, conducting, and HUMAN SERVICES
instructions for submitting comments.
documenting such formal meetings. The Food and Drug Administration Comments submitted electronically,
general principles in this guidance may including attachments, to https://
be extended to other nonapplication- [Docket No. FDA–2017–D–6564] www.regulations.gov will be posted to
related meetings with external the docket unchanged. Because your
ethrower on DSK3G9T082PROD with NOTICES
constituents, insofar as this is possible. Best Practices for Communication
comment will be made public, you are
Between Investigational New Drug
The previous guidance for industry solely responsible for ensuring that your
Application Sponsors and the Food
‘‘Formal Meetings Between the FDA and comment does not include any
and Drug Administration; Guidance for
Sponsors or Applicants’’ published May confidential information that you or a
Industry and Review Staff; Availability
19, 2009, and the draft guidance for third party may not wish to be posted,
industry ‘‘Formal Meetings Between the AGENCY: Food and Drug Administration, such as medical information, your or
FDA and Sponsors or Applicants of HHS. anyone else’s Social Security number, or
VerDate Sep<11>2014 20:09 Dec 28, 2017 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1](https://thefederalregister.org/doc/82_FR_62012/page/2.svg)
Document Created: 2018-01-03 13:16:47
Document Modified: 2018-01-03 13:16:47
| 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 March 29, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Rachel B. Kichline, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301- 796-0319; 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 61763 |
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