80 FR 17051 - Critical Path Innovation Meetings; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 61 (March 31, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 61 (March 31, 2015)
| Page Range | 17051-17052 | |
| FR Document | 2015-07272 |
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)] [Notices] [Pages 17051-17052] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07272] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1439] Critical Path Innovation Meetings; 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 guidance for industry entitled ``Critical Path Innovation Meetings.'' This guidance describes a Critical Path Innovation Meeting (CPIM), a means by which FDA's Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, government, and patient advocacy groups can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food [[Page 17052]] and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the 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: Alicia Barbieri Stuart, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4547, Silver Spring, MD 20993-0002, 301-796-3852. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Critical Path Innovation Meetings.'' The guidance describes the purpose and scope of a CPIM and how to request such a meeting. A CPIM provides the opportunity to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how the methodology or technology might enhance drug development. During a CPIM, CDER will identify some of the larger gaps in existing knowledge that requesters might consider addressing in the course of their work. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters. The CPIM initiative meets Prescription Drug User Fee Act (PDUFA) V Reauthorization Goal IX.A, ``Enhancing Regulatory Science and Expediting Drug Development'' by ``Promoting Innovation Through Enhanced Communication Between FDA and Sponsors During Drug Development.'' This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Critical Path Innovation Meetings.'' 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. II. The Paperwork Reduction Act of 1995 This 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 collection of information in 21 CFR part 312 (investigational new drug applications) has been approved under OMB control number 0910-0014. The collection of information in 21 CFR part 314 (new drug applications) has been approved under OMB control number 0910-0001. The collection of information resulting from formal meetings between interested persons and FDA has been approved under OMB control number 0910-0429. 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 either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: March 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07272 Filed 3-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17051
SUMMARY: The Food and Drug In the Federal Register of February Management (see ADDRESSES). It is only
Administration (FDA) is announcing a 21, 2012 (77 FR 9947), FDA announced necessary to send one set of comments.
request for additional comments on the the publication of a final guidance Identify comments with the docket
chemistry, manufacturing, and control entitled ‘‘Early Clinical Trials with Live number found in brackets in the
(CMC) information that a sponsor of an Biotherapeutic Products: Chemistry, heading of this document. Received
investigational new drug application Manufacturing, and Control comments may be seen in the Division
(IND) should provide in its IND in order Information; Guidance for Industry,’’ of Dockets Management between 9 a.m.
to meet regulatory requirements when dated February 2012. The guidance and 4 p.m., Monday through Friday, and
commercially available foods or dietary provides IND sponsors with will be posted to the docket at http://
supplements containing live recommendations regarding CMC www.regulations.gov.
biotherapeutic products (LBPs) are used information that should be included in
as investigational new drugs in early IND submissions for early clinical trials IV. Electronic Access
phase clinical trials. The request for with LBPs, including LBPs lawfully Persons with access to the Internet
additional comments on the CMC marketed as foods or dietary may obtain the February 2012 guidance
information is related to the guidance supplements in the United States and at either http://www.fda.gov/Biologics
entitled, ‘‘Early Clinical Trials with Live proposed for clinical uses regulated BloodVaccines/GuidanceCompliance
Biotherapeutic Products: Chemistry, under section 351 of the Public Health RegulatoryInformation/Guidances/
Manufacturing, and Control Service Act (42 U.S.C. 262). The default.htm or http://www.regulations.
Information; Guidance for Industry,’’ guidance also outlines the Drug gov.
dated February 2012 (February 2012 Substance and Drug Product Dated: March 25, 2015.
guidance). information that should be provided in
Leslie Kux,
DATES: Submit either electronic or the CMC section of an IND to meet the
Associate Commissioner for Policy.
written comments on the requested requirements under § 312.23 and to
support proceeding to clinical [FR Doc. 2015–07273 Filed 3–30–15; 8:45 am]
CMC information by May 29, 2015.
evaluation of an LBP in human subjects. BILLING CODE 4164–01–P
ADDRESSES: Submit written requests for
single copies of the February 2012 II. CMC Information
guidance to the Office of FDA is considering modifying the DEPARTMENT OF HEALTH AND
Communication, Outreach and February 2012 guidance to address the HUMAN SERVICES
Development, Center for Biologics CMC information that should be
Evaluation and Research (CBER), Food provided in an IND, under certain Food and Drug Administration
and Drug Administration, 10903 New conditions. Specifically, FDA is [Docket No. FDA–2014–D–1439]
Hampshire Ave., Bldg. 71, rm. 3128, considering whether to revise the
Silver Spring, MD 20993–0002. Send guidance to address when the label on Critical Path Innovation Meetings;
one self-addressed adhesive label to the commercially available product(s) Guidance for Industry; Availability
assist the office in processing your would be considered adequate to satisfy
requests. The guidance may also be AGENCY: Food and Drug Administration,
the requirement for CMC information
obtained by mail by calling CBER at 1– HHS.
under § 312.23. For example, we are
800–835–4709 or 240–402–7800. See considering whether the label would be ACTION: Notice.
the SUPPLEMENTARY INFORMATION section adequate to satisfy the CMC information
for electronic access to the guidance SUMMARY: The Food and Drug
when the following conditions are met: Administration (FDA) is announcing the
document. (1) The LBP product that is proposed for
Submit electronic comments on the availability of a guidance for industry
investigational use is a commercially
requested CMC information to http:// entitled ‘‘Critical Path Innovation
available food or dietary supplement; (2)
www.regulations.gov. Submit written Meetings.’’ This guidance describes a
the investigation does not involve a
comments to the Division of Dockets Critical Path Innovation Meeting
route of administration, dose, patient
Management (HFA–305), Food and Drug (CPIM), a means by which FDA’s Center
population, or other factor that
Administration, 5630 Fishers Lane, Rm. for Drug Evaluation and Research
significantly increases the risk (or
1061, Rockville, MD 20852. (CDER) and investigators from industry,
decreases the acceptability of risk)
FOR FURTHER INFORMATION CONTACT:
academia, government, and patient
associated with the use of the food or
Jessica T. Walker, Center for Biologics advocacy groups can communicate to
dietary supplement; (3) the investigation
Evaluation and Research, Food and improve efficiency and success in drug
is not intended to support a marketing
Drug Administration, 10903 New development. The goals of the CPIM are
application for a drug claim for the food
Hampshire Ave., Bldg. 71, Rm. 7301, to discuss a methodology or technology
or dietary supplement; and (4) the
Silver Spring, MD 20993–0002, 240– proposed by the meeting requester and
investigation is conducted in
402–7911. for CDER to provide general advice on
compliance with the requirements for
how this methodology or technology
SUPPLEMENTARY INFORMATION: INDs (part 312), the requirements for
might enhance drug development. The
review by an institutional review board
I. Background discussions and background
(21 CFR part 56), and with the
FDA is announcing a request for information submitted through the
requirements for informed consent (21
additional comments on the CMC CPIM are nonbinding on both FDA and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
CFR part 50). FDA is seeking public
information that a sponsor of an IND CPIM requesters.
comment on this issue.
should provide in its IND in order to DATES: Submit either electronic or
meet the requirements under § 312.23 III. Comments written comments on Agency guidances
(21 CFR 312.23), when commercially Interested persons may submit either at any time.
available foods or dietary supplements electronic comments regarding the ADDRESSES: Submit written requests for
containing LBPs are subject to study as requested CMC information to http:// single copies of this guidance to the
investigational new drugs in early phase www.regulations.gov or written Division of Drug Information, Center for
clinical trials. comments to the Division of Dockets Drug Evaluation and Research, Food
VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1](https://thefederalregister.org/doc/80_FR_17112/page/1.svg)
![17052 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
and Drug Administration, 10001 New are subject to review by the Office of recommendations to the Agency on
Hampshire Ave., Hillandale Building, Management and Budget (OMB) under FDA’s regulatory issues.
4th Floor, Silver Spring, MD 20993. the Paperwork Reduction Act of 1995 Date and Time: The meeting will be
Send one self-addressed adhesive label (44 U.S.C. 3501–3520). The collection of held on May 12, 2015, from 8 a.m. to 4
to assist that office in processing your information in 21 CFR part 312 p.m.
requests. See the SUPPLEMENTARY (investigational new drug applications) Location: Hilton Washington DC
INFORMATION section for electronic has been approved under OMB control North/Gaithersburg, The Ballrooms, 620
access to the guidance document. number 0910–0014. The collection of Perry Pkwy., Gaithersburg, MD 20877.
Submit electronic comments on the information in 21 CFR part 314 (new The hotel phone number is 301–977–
guidance to http://www.regulations.gov. drug applications) has been approved 8900.
Submit written comments to the under OMB control number 0910–0001. Contact Person: Cindy Hong, Center
Division of Dockets Management (HFA– The collection of information resulting for Drug Evaluation and Research, Food
305), Food and Drug Administration, from formal meetings between and Drug Administration, 10903 New
5630 Fishers Lane, Rm. 1061, Rockville, interested persons and FDA has been Hampshire Ave., Bldg. 31, Rm. 2417,
MD 20852. approved under OMB control number Silver Spring, MD 20993–0002, 301–
FOR FURTHER INFORMATION CONTACT: 0910–0429. 796–9001, FAX: 301–847–8533, email:
Alicia Barbieri Stuart, Office of PADAC@fda.hhs.gov, or FDA Advisory
Translational Sciences, Center for Drug III. Comments Committee Information Line, 1–800–
Evaluation and Research, Food and Interested persons may submit either 741–8138 (301–443–0572 in the
Drug Administration, 10903 New electronic comments regarding this Washington, DC area). A notice in the
Hampshire Ave., Bldg. 21, Rm. 4547, document to http://www.regulations.gov Federal Register about last minute
Silver Spring, MD 20993–0002, 301– or written comments to the Division of modifications that impact a previously
796–3852. Dockets Management (see ADDRESSES). It announced advisory committee meeting
SUPPLEMENTARY INFORMATION: is only necessary to send one set of cannot always be published quickly
comments. Identify comments with the enough to provide timely notice.
I. Background docket number found in brackets in the Therefore, you should always check the
FDA is announcing the availability of heading of this document. Received Agency’s Web site at http://
a guidance for industry entitled comments may be seen in the Division www.fda.gov/AdvisoryCommittees/
‘‘Critical Path Innovation Meetings.’’ of Dockets Management between 9 a.m. default.htm and scroll down to the
The guidance describes the purpose and and 4 p.m., Monday through Friday, and appropriate advisory committee meeting
scope of a CPIM and how to request will be posted to the docket at http:// link, or call the advisory committee
such a meeting. A CPIM provides the www.regulations.gov. information line to learn about possible
opportunity to discuss a methodology or modifications before coming to the
technology proposed by the meeting IV. Electronic Access meeting.
requester and for CDER to provide Persons with access to the Internet Agenda: The committee will discuss
general advice on how the methodology may obtain the document at either new drug application (NDA) 206038,
or technology might enhance drug http://www.fda.gov/Drugs/Guidance lumacaftor/ivacaftor combination tablets
development. During a CPIM, CDER will ComplianceRegulatoryInformation/ for oral use, submitted by Vertex
identify some of the larger gaps in Guidances/default.htm or http://www. Pharmaceuticals, proposed for the
existing knowledge that requesters regulations.gov. treatment of cystic fibrosis (CF) in
might consider addressing in the course patients age 12 years and older who are
Dated: March 24, 2015.
of their work. The discussions and homozygous for the F508del mutation in
Leslie Kux, the cystic fibrosis transmembrane
background information submitted Associate Commissioner for Policy.
through the CPIM are nonbinding on conductance regulator (CFTR) gene.
both FDA and CPIM requesters. The [FR Doc. 2015–07272 Filed 3–30–15; 8:45 am] FDA intends to make background
CPIM initiative meets Prescription Drug BILLING CODE 4164–01–P material available to the public no later
User Fee Act (PDUFA) V than 2 business days before the meeting.
Reauthorization Goal IX.A, ‘‘Enhancing If FDA is unable to post the background
DEPARTMENT OF HEALTH AND material on its Web site prior to the
Regulatory Science and Expediting Drug
HUMAN SERVICES meeting, the background material will
Development’’ by ‘‘Promoting
Innovation Through Enhanced be made publicly available at the
Food and Drug Administration location of the advisory committee
Communication Between FDA and
Sponsors During Drug Development.’’ [Docket No. FDA–2015–N–0001] meeting, and the background material
This guidance is being issued will be posted on FDA’s Web site after
consistent with FDA’s good guidance Pulmonary-Allergy Drugs Advisory the meeting. Background material is
practices regulation (21 CFR 10.115). Committee; Notice of Meeting available at http://www.fda.gov/
The guidance represents the current AGENCY: Food and Drug Administration, AdvisoryCommittees/Calendar/
thinking of FDA on ‘‘Critical Path HHS. default.htm. Scroll down to the
Innovation Meetings.’’ It does not ACTION: Notice. appropriate advisory committee meeting
establish any rights for any person and link.
Procedure: Interested persons may
asabaliauskas on DSK5VPTVN1PROD with NOTICES
is not binding on FDA or the public. This notice announces a forthcoming
You can use an alternative approach if meeting of a public advisory committee present data, information, or views,
it satisfies the requirements of the of the Food and Drug Administration orally or in writing, on issues pending
applicable statutes and regulations. (FDA). The meeting will be open to the before the committee. Written
public. submissions may be made to the contact
II. The Paperwork Reduction Act of Name of Committee: Pulmonary- person on or before April 27, 2015. Oral
1995 Allergy Drugs Advisory Committee. presentations from the public will be
This guidance refers to previously General Function of the Committee: scheduled between approximately 1
approved collections of information that To provide advice and p.m. and 2 p.m. Those individuals
VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1](https://thefederalregister.org/doc/80_FR_17112/page/2.svg)
Document Created: 2015-12-18 11:47:56
Document Modified: 2015-12-18 11:47:56
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Alicia Barbieri Stuart, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4547, Silver Spring, MD 20993-0002, 301-796-3852. | |
| FR Citation | 80 FR 17051 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR