80 FR 12822 - 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Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability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 80, Issue 47 (March 11, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 47 (March 11, 2015)
| Page Range | 12822-12823 | |
| FR Document | 2015-05523 |
[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)] [Notices] [Pages 12822-12823] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05523] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-1315 (formerly 1999-D-0296)] 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Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological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 (``products''). This draft guidance revises the guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 9, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993- 0002, or 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Rachel E. Hartford, 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 draft 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). This draft 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 draft guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible. This draft guidance revises the guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009. This draft guidance is being [[Page 12823]] updated in accordance with the Meeting Management Goals section of the PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 2013 through 2017. Significant changes from the 2009 guidance include:Addition of the written response meeting format for pre- investigational new drug application and Type C meetings Designation of a post-action meeting requested within 3 months after an FDA regulatory action other than approval as a Type A meeting Designation of a post-action meeting requested 3 or more months after an FDA regulatory action other than approval as a Type B meeting Designation of a meeting regarding risk evaluation and mitigation strategies or postmarketing requirements that occur outside the context of the review of a marketing application as a Type B meeting Inclusion of a meeting package in Type A meeting requests Designation of meetings to discuss the overall development program for products granted breakthrough therapy designation status as a Type B meeting 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 Agency's current thinking on formal meetings between FDA and sponsors or applicants of PDUFA products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. 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. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: March 5, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05523 Filed 3-10-15; 8:45 am] BILLING CODE 4164-01-P
![12822 Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices
Institute for Occupational Safety and controls to reduce the concentration of toxic Silver Spring, MD 20993–0002. Send
Health (CC), insert the following: substances in the mine air; (5) conducts one self-addressed adhesive label to
laboratory and field studies to help leverage assist that office in processing your
Western States Division (CCQ). The and support the Institute’s mining research
Western States Division (WSD) conducts requests. See the SUPPLEMENTARY
program; (6) develops and recommends
research and provides technical assistance INFORMATION section for electronic
appropriate criteria for new standards,
for the prevention of work-related illness, NIOSH policy, documents, or testimony access to the draft guidance document.
injury, and death; these activities are related to health and safety in the extractive Submit electronic comments on the
predominately focused on, but not limited to, industries. draft guidance to http://www.
occupational safety and health (OS&H) regulations.gov. Submit written
problems in the Western U.S., including James Seligman,
Alaska and Hawaii. WSD conducts specific
comments to the Division of Dockets
Acting Chief Operating Officer, Centers for Management (HFA–305), Food and Drug
activities that provide actionable evidence to Disease Control and Prevention.
reduce OS&H hazards. To accomplish its Administration, 5630 Fishers Lane, Rm.
[FR Doc. 2015–05552 Filed 3–10–15; 8:45 am] 1061, Rockville, MD 20852.
mission, WSD: (1) Conducts prevention
research for at risk populations; (2) facilitates BILLING CODE P
FOR FURTHER INFORMATION CONTACT:
the development of OS&H programs in states Rachel E. Hartford, Center for Drug
and regions that have minimal or limited
Evaluation and Research, Food and
OS&H public health program capacity and DEPARTMENT OF HEALTH AND
state-supporting infrastructure; (3) serves as a Drug Administration, 10903 New
HUMAN SERVICES
multi-regional resource to provide outreach, Hampshire Ave., Bldg. 22, Rm. 6312,
expert advice, and technical assistance on Food and Drug Administration Silver Spring, MD 20993–0002, 301–
OS&H priority issues, including the 796–0319; or Stephen Ripley, Center for
development, dissemination, and diffusion of [Docket No. FDA–1999–D–1315 (formerly Biologics Evaluation and Research,
NIOSH research products; (4) enhances and 1999–D–0296)] Food and Drug Administration, 10903
facilitates NIOSH initiatives and programs; New Hampshire Ave., Bldg. 71, Rm.
and (5) responds to requests for technical Formal Meetings Between the Food
and Drug Administration and Sponsors 7301, Silver Spring, MD 20993–0002,
assistance and conducts site evaluations to
support Division programs and priorities and or Applicants of Prescription Drug 240–402–7911.
other NIOSH initiatives and programs, User Fee Act Products; Draft Guidance SUPPLEMENTARY INFORMATION:
including evaluating exposures to hazardous for Industry; Availability
chemical, biological, physical, and
I. Background
radioactive agents and recommending AGENCY: Food and Drug Administration, FDA is announcing the availability of
appropriate controls. Research includes the HHS. a draft guidance for industry entitled
development of viable strategies to evaluate ACTION: Notice. ‘‘Formal Meetings Between the FDA and
and prioritize hazards, communicate risk, Sponsors or Applicants of PDUFA
provide evidence for prevention SUMMARY: The Food and Drug Products.’’ This draft guidance provides
recommendations, and building state OS&H Administration (FDA) is announcing the
(capacity or activities) through surveillance recommendations to industry on formal
availability of a draft guidance for meetings between FDA and sponsors or
data and stakeholder input. At risk
industry entitled ‘‘Formal Meetings applicants relating to the development
populations include, but are not limited to,
(a) high-risk industries such as oil and gas Between the FDA and Sponsors or and review of products regulated by the
extraction, fishing, and aviation; (b) Applicants of Prescription Drug User Center for Drug Evaluation and Research
underserved groups such as American Fee Act (PDUFA) Products.’’ This draft and the Center for Biologics Evaluation
Indian/Alaska Native and immigrant and guidance provides recommendations to and Research. This draft guidance does
contingent workers; and (c) workers engaged industry on formal meetings between not apply to abbreviated new drug
in particularly hazardous activities such as FDA and sponsors or applicants relating applications, applications for biosimilar
hydraulic fracturing, wind and other to the development and review of drug
renewable energy development, wild land biological products, or submissions for
or biological products (‘‘products’’). medical devices. For the purposes of
firefighting; and water and air transportation.
This draft guidance revises the guidance this draft guidance, ‘‘formal meeting’’
After the title and functional for industry entitled ‘‘Formal Meetings includes any meeting that is requested
statement for the Office of Mine Safety Between the FDA and Sponsors or by a sponsor or applicant following the
and Health Research (CCM), National Applicants’’ published May 19, 2009. request procedures provided in this
Institute for Occupational Safety and DATES: Although you can comment on guidance and includes meetings
Health (CC), insert the following: any guidance at any time (see 21 CFR conducted in any format (i.e., face to
Spokane Mining Research Division 10.115(g)(5)), to ensure that the Agency face, teleconference, videoconference, or
(CCMG). (1) Provides leadership for considers your comment on this draft written response).
prevention of work-related illness, injury, guidance before it begins work on the This draft guidance discusses the
and death in the extractive industries with an final version of the guidance, submit principles of good meeting management
emphasis on the special needs of these either electronic or written comments
industries in western United States; (2) practices and describes standardized
develops numerical models and conducts
on the draft guidance by June 9, 2015. procedures for requesting, preparing for,
laboratory and field investigations to better ADDRESSES: Submit written requests for scheduling, conducting, and
understand the causes of catastrophic failures single copies of the draft guidance to the documenting such formal meetings. The
in underground metal/nonmetal mines that Division of Drug Information, Center for general principles in this draft guidance
may lead to multiple injuries and fatalities; Drug Evaluation and Research, Food may be extended to other
(3) develops new design practices and tools, and Drug Administration, 10001 New nonapplication-related meetings with
Rmajette on DSK2VPTVN1PROD with NOTICES
control technologies, and work practices to Hampshire Ave., Hillandale Bldg., 4th external constituents, insofar as this is
reduce the risk of these global and local Floor, Silver Spring, MD 20993–0002, or possible.
ground failures in underground metal/
nonmetal mines; (4) conducts numerical
the Office of Communication, Outreach, This draft guidance revises the
studies and field investigations to understand and Development, Center for Biologics guidance for industry entitled ‘‘Formal
the problems of ventilating deep and Evaluation and Research, Food and Meetings Between the FDA and
multilevel underground mines, and develops Drug Administration, 10903 New Sponsors or Applicants’’ published May
improved design approaches and engineering Hampshire Ave., Bldg. 71, Rm. 3128, 19, 2009. This draft guidance is being
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![Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices 12823
updated in accordance with the Meeting been approved under OMB control Drug Administration, 10903 New
Management Goals section of the number 0910–0338. Hampshire Ave., Bldg. 31, Rm. 2417,
PDUFA Reauthorization Performance Silver Spring, MD 20993–0002, 301–
III. Comments
Goals and Procedures, Fiscal Years 2013 796–9001, FAX: 301–847–8533, email:
through 2017. Significant changes from Interested persons may submit either AAC@fda.hhs.gov, or FDA Advisory
the 2009 guidance include: electronic comments regarding this Committee Information Line, 1–800–
• Addition of the written response document to http://www.regulations.gov 741–8138 (301–443–0572 in the
meeting format for pre-investigational or written comments to the Division of Washington, DC area). Please call the
new drug application and Type C Dockets Management (see ADDRESSES). It Information Line for up-to-date
meetings is only necessary to send one set of information on this meeting.
• Designation of a post-action meeting comments. Identify comments with the
Dated: March 6, 2015.
requested within 3 months after an docket number found in brackets in the
Leslie Kux,
FDA regulatory action other than heading of this document. Received
comments may be seen in the Division Associate Commissioner for Policy.
approval as a Type A meeting
• Designation of a post-action meeting of Dockets Management between 9 a.m. [FR Doc. 2015–05527 Filed 3–10–15; 8:45 am]
requested 3 or more months after an and 4 p.m., Monday through Friday, and BILLING CODE 4164–01–P
FDA regulatory action other than will be posted to the docket at http://
approval as a Type B meeting www.regulations.gov.
• Designation of a meeting regarding DEPARTMENT OF HEALTH AND
IV. Electronic Access HUMAN SERVICES
risk evaluation and mitigation
strategies or postmarketing Persons with access to the Internet
may obtain the document at http:// Administration for Children and
requirements that occur outside the
www.fda.gov/Drugs/ Families
context of the review of a marketing
application as a Type B meeting GuidanceComplianceRegulatory
Submission for OMB Review;
• Inclusion of a meeting package in Information/Guidances/default.htm,
Comment Request
Type A meeting requests http://www.fda.gov/BiologicsBlood
• Designation of meetings to discuss the Vaccines/Guidance Title: Temporary Assistance for Needy
overall development program for ComplianceRegulatoryInformation/ Families Two-Parent Study.
products granted breakthrough default.htm, or http://www.
OMB No.: New Collection.
therapy designation status as a Type regulations.gov.
B meeting Description: The Administration for
Dated: March 5, 2015. Children and Families (ACF) is
This draft guidance is being issued Leslie Kux, proposing an information collection
consistent with FDA’s good guidance Associate Commissioner for Policy. activity as part of the Temporary
practices regulation (21 CFR 10.115). [FR Doc. 2015–05523 Filed 3–10–15; 8:45 am] Assistance for Needy Families Two-
The draft guidance, when finalized, will
BILLING CODE 4164–01–P Parent Study. Through this information
represent the Agency’s current thinking
collection, ACF seeks to gain an in-
on formal meetings between FDA and
depth, systematic understanding of the
sponsors or applicants of PDUFA DEPARTMENT OF HEALTH AND characteristics of two-parent families
products. It does not create or confer HUMAN SERVICES participating in or eligible to receive
any rights for or on any person and does
TANF, the variety of services two-parent
not operate to bind FDA or the public. Food and Drug Administration families receive through TANF, how
An alternative approach may be used if
[Docket No. FDA–2015–N–0001] state policies may affect participation in
such approach satisfies the
TANF among two-parent families, and
requirements of the applicable statutes Arthritis Advisory Committee: Notice how the beliefs of staff and eligible
and regulations. of Postponement of Meeting families affect two-parent families’
II. The Paperwork Reduction Act of participation in TANF.
AGENCY: Food and Drug Administration,
1995 HHS. The proposed information collection
This draft guidance refers to ACTION: Notice. consists of semi-structured interviews
previously approved collections of with key State and local staff,
information that are subject to review by SUMMARY: The Food and Drug community-based organization
the Office of Management and Budget Administration (FDA) is postponing the representatives, and adult members of
(OMB) under the Paperwork Reduction meeting of the Arthritis Advisory two-parent TANF or likely eligible
Act of 1995 (44 U.S.C. 3501–3520). The Committee scheduled for March 17, families on questions of TANF policies,
collections of information referred to in 2015. The meeting was announced in service delivery, and program context,
the guidance entitled ‘‘Formal Meetings the Federal Register of February 10, as well as focus groups with adult
Between the FDA and Sponsors or 2015 (80 FR 7480). The postponement is members of two-parent TANF or likely
Applicants’’ have been approved under due to information requests pending eligible families.
OMB control number 0910–0429. The with the sponsor of the application. A Respondents: State- and local-level
collections of information for Form FDA future meeting date will be announced TANF administrators and staff,
1571 and end-of-phase 2 meetings have in the Federal Register. representatives from community-based
Rmajette on DSK2VPTVN1PROD with NOTICES
been approved under OMB control FOR FURTHER INFORMATION CONTACT: organizations, and adults from two-
number 0910–0014, and collections of Stephanie L. Begansky, Center for Drug parent families on or likely eligible for
information for Form FDA 356h have Evaluation and Research, Food and TANF.
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Document Created: 2015-12-18 11:58:22
Document Modified: 2015-12-18 11:58:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Although you can comment on any 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 June 9, 2015. | |
| Contact | Rachel E. Hartford, 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 | 80 FR 12822 |
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