80 FR 29010 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 97 (May 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 97 (May 20, 2015)
| Page Range | 29010-29012 | |
| FR Document | 2015-12170 |
[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)] [Notices] [Pages 29010-29012] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12170] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0247] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products. DATES: Submit either electronic or written comments on the collection of information by July 20, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA, (44 U.S.C. 3501-3520), Federal [[Page 29011]] 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. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products OMB Control Number 0910-0429--Extension This information collection approval request is for FDA guidance on the procedures for formal meetings between FDA and sponsors or applicants regarding the development and review of PDUFA products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how the Agency will interpret and apply section 119(a) of the Food and Drug Administration Modernization Act (FDAMA), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (Sec. Sec. 312.47 and 312.82 (21 CFR 312.47 and 312.82)). The guidance describes two collections of information: The submission of a meeting request containing certain information and the submission of an information package in advance of the formal meeting. Agency regulations at Sec. Sec. 312.47(b)(1)(ii), (b)(1)(iv), and (b)(2) describe information that should be submitted in support of a request for an end-of-phase 2 meeting and a pre-NDA meeting. The information collection provisions of Sec. 312.47 have been approved by OMB control number 0910-0014. However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting additional estimates for OMB approval. I. Request for a Meeting Under the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) should submit a meeting request to the appropriate FDA component as an amendment to the underlying application. FDA regulations (Sec. Sec. 312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information provided to the Agency as part of an investigational new drug application (IND), new drug application (NDA), or biological license application (BLA) must be submitted with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs and BLAs. Both forms have valid OMB control numbers as follows: Form FDA 1571--OMB control number 0910- 0014 and Form FDA 356h--OMB control number 0910-0338. In the guidance document, CDER and CBER ask that a request for a formal meeting be submitted as an amendment to the application for the underlying product under the requirements of Sec. Sec. 312.23, 314.50, and 601.2; therefore, requests should be submitted to the Agency with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted in this manner for two reasons: (1) To ensure that each request is kept in the administrative file with the entire underlying application, and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the Agency to monitor progress on the activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner. Under the guidance, the Agency requests that sponsors and applicants include in meeting requests certain information about the proposed meeting. Such information includes:Information identifying and describing the product; The type of meeting being requested; A brief statement of the purpose of the meeting; A list of objectives and expected outcomes from the meeting; A preliminary proposed agenda; A draft list of questions to be raised at the meeting; A list of individuals who will represent the sponsor or applicant at the meeting; A list of Agency staff requested to be in attendance; The approximate date that the information package will be sent to the Agency; and Suggested dates and times for the meeting. This information will be used by the Agency to determine the utility of the meeting, to identify Agency staff necessary to discuss proposed agenda items, and to schedule the meeting. II. Information Package A sponsor or applicant submitting an information package to the Agency in advance of a formal meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or Agency. The Agency recommends that information packages generally include: Identifying information about the underlying product; A brief statement of the purpose of the meeting; A list of objectives and expected outcomes of the meeting; A proposed agenda for the meeting; A list of specific questions to be addressed at the meeting; A summary of clinical data that will be discussed (as appropriate); A summary of preclinical data that will be discussed (as appropriate); and Chemistry, manufacturing, and controls information that may be discussed (as appropriate). The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. Although FDA reviews similar information in the meeting request, the information package should provide updated data that reflect the most current and accurate information available to the sponsor or applicant. [[Page 29012]] The Agency finds that reviewing such information is critical to achieving a productive meeting. The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests as amendments to INDs, NDAs, and BLAs and to submit background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an end-of-phase 2 meeting (Sec. Sec. 312.47(b)(1)(ii) and (b)(1)(iv)) and a pre-NDA meeting (Sec. 312.47(b)(2)). Description of Respondents: A sponsor or applicant for a drug or biological product who requests a formal meeting with the Agency regarding the development and review of a PDUFA product. Burden Estimate: Provided in this document is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance. III. Request for a Formal Meeting Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 1,099 sponsors and applicants (respondents) request approximately 2,366 formal meetings with CDER annually and approximately 175 respondents request approximately 264 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 10 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting. IV. Information Package Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 959 respondents submitted approximately 1,901 information packages to CDER annually and approximately 142 respondents submitted approximately 193 information packages to CBER annually prior to a formal meeting regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the Agency. As stated earlier, the guidance provides information on how the Agency will interpret and apply section 119(a) of the FDAMA, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (Sec. Sec. 312.47 and 312.82). The information collection provisions in Sec. 312.47 concerning end-of-phase 2 meetings and pre-NDA meetings have been approved by OMB control number 0910-0014. However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting for OMB approval these additional estimates. Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Meeting requests and information Number of responses per Total annual Average burden Total hours packages respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Meeting Requests: CDER........................ 1,099 2.15 2,366 10 23,660 CBER........................ 175 1.51 264 10 2,640 ------------------------------------------------------------------------------- Total................... .............. .............. .............. .............. 26,300 Information Packages: CDER........................ 959 1.99 1,901 18 34,218 CBER........................ 142 1.36 193 18 3,474 ------------------------------------------------------------------------------- Total................... .............. .............. .............. .............. 37,692 =============================================================================== Grand Total......... .............. .............. .............. .............. 63,992 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 14, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-12170 Filed 5-19-15; 8:45 am] BILLING CODE 4164-01-P
![29010 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices
Disease Control and Prevention (CDC) Advisory Commission on Childhood Dated: May 15,2015.
within the Department of Health and Vaccines, appropriate health care Ron A. Otten,
Human Services (HHS) develops provider and parent organizations, and Acting Deputy Associate Director for Science,
vaccine information materials that all the Food and Drug Administration. The Centers for Disease Control and Prevention.
health care providers are required to law also requires that the information [FR Doc. 2015–12239 Filed 5–19–15; 8:45 am]
give to patients/parents prior to contained in the materials be based on BILLING CODE 4163–18–P
administration of specific vaccines. available data and information, be
HHS/CDC seeks written comment on the presented in understandable terms, and
proposed updated vaccine information include: DEPARTMENT OF HEALTH AND
statement for pneumococcal conjugate (1) A concise description of the HUMAN SERVICES
vaccine (PCV13). benefits of the vaccine,
DATES: Written comments must be (2) A concise description of the risks Food and Drug Administration
received on or before July 20, 2015. associated with the vaccine,
(3) A statement of the availability of [Docket No. FDA–2012–N–0247]
ADDRESSES: You may submit comments,
the National Vaccine Injury Agency Information Collection
identified by Docket No. CDC–2015–
Compensation Program, and Activities; Proposed Collection;
0014, by any of the following methods: (4) Such other relevant information as
• Federal eRulemaking Portal: http:// Comment Request; Guidance for
may be determined by the Secretary.
www.regulations.gov. Follow the The vaccines initially covered under Industry on Formal Meetings With
instructions for submitting comments. the National Vaccine Injury Sponsors and Applicants for
• Mail: Written comments should be Prescription Drug User Fee Act
Compensation Program were diphtheria,
addressed to Suzanne Johnson-DeLeon Products
tetanus, pertussis, measles, mumps,
(msj1@cdc.gov), National Center for
rubella and poliomyelitis vaccines. AGENCY: Food and Drug Administration,
Immunization and Respiratory Diseases,
Since April 15, 1992, any health care HHS.
Centers for Disease Control and
provider in the United States who ACTION: Notice.
Prevention, Mailstop A–19, 1600 Clifton
intends to administer one of these
Road NE., Atlanta, Georgia 30329.
Instructions: All submissions received covered vaccines is required to provide SUMMARY: The Food and Drug
must include the agency name and copies of the relevant vaccine Administration (FDA) is announcing an
docket number. All relevant comments information materials prior to opportunity for public comment on the
received will be posted without change administration of any of these vaccines. proposed collection of certain
to http://regulations.gov, including any Since then, the following vaccines have information by the Agency. Under the
personal information provided. For been added to the National Vaccine Paperwork Reduction Act of 1995 (the
access to the docket to read background Injury Compensation Program, requiring PRA), Federal Agencies are required to
documents or comments received, go to use of vaccine information materials for publish notice in the Federal Register
http://www.regulations.gov. them as well: Hepatitis B, Haemophilus concerning each proposed collection of
influenzae type b (Hib), varicella information, including each proposed
FOR FURTHER INFORMATION CONTACT: Skip
(chickenpox), pneumococcal conjugate, extension of an existing collection of
Wolfe (crw4@cdc.gov), National Center
rotavirus, hepatitis A, meningococcal, information, and to allow 60 days for
for Immunization and Respiratory
human papillomavirus (HPV), and public comment in response to the
Diseases, Centers for Disease Control
seasonal influenza vaccines. notice. This notice solicits comments on
and Prevention, Mailstop A–19, 1600
Instructions for use of the vaccine the information collection contained in
Clifton Road NE., Atlanta, Georgia
information materials are found on the the guidance for industry on formal
30329.
CDC Web site at: http://www.cdc.gov/ meetings with sponsors and applicants
SUPPLEMENTARY INFORMATION: The vaccines/hcp/vis/index.html. for Prescription Drug User Fee Act
National Childhood Vaccine Injury Act HHS/CDC is proposing an updated (PDUFA) products.
of 1986 (Pub. L. 99–660), as amended by version of the pneumococcal conjugate DATES: Submit either electronic or
section 708 of Public Law 103–183, vaccine (PCV13) vaccine information written comments on the collection of
added section 2126 to the Public Health statement. information by July 20, 2015.
Service Act. Section 2126, codified at 42 The vaccine information materials ADDRESSES: Submit electronic
U.S.C. 300aa–26, requires the Secretary referenced in this notice are being comments on the collection of
of Health and Human Services to developed in consultation with the information to http://
develop and disseminate vaccine Advisory Commission on Childhood www.regulations.gov. Submit written
information materials for distribution by Vaccines, the Food and Drug comments on the collection of
all health care providers in the United Administration, and parent and health information to the Division of Dockets
States to any patient (or to the parent or care provider groups. Management (HFA–305), Food and Drug
legal representative in the case of a We invite written comment on the
Administration, 5630 Fishers Lane, Rm.
child) receiving vaccines covered under proposed vaccine information materials
1061, Rockville, MD 20852. All
the National Vaccine Injury entitled ‘‘Pneumococcal Conjugate
comments should be identified with the
Compensation Program (VICP). Vaccine (PCV13): What You Need to
docket number found in brackets in the
Development and revision of the Know.’’ A copy of the proposed vaccine
heading of this document.
vaccine information materials, also information materials is available at
FOR FURTHER INFORMATION CONTACT: FDA
mstockstill on DSK4VPTVN1PROD with NOTICES
known as Vaccine Information http://www.regulations.gov (see Docket
Statements (VIS), have been delegated Number CDC–2015–0014). Comments PRA Staff, Office of Operations, Food
by the Secretary to the Centers for submitted will be considered in and Drug Administration, 8455
Disease Control and Prevention (CDC). finalizing these materials. When the Colesville Rd., COLE–14526, Silver
Section 2126 requires that the materials final materials are published in the Spring, MD 20993–0002, PRAStaff@
be developed, or revised, after notice to Federal Register, the notice will include fda.hhs.gov.
the public, with a 60-day comment an effective date for their mandatory SUPPLEMENTARY INFORMATION: Under the
period, and in consultation with the use. PRA, (44 U.S.C. 3501–3520), Federal
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![29012 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices
The Agency finds that reviewing such applicants (respondents) request is the estimated number of hours that a
information is critical to achieving a approximately 2,366 formal meetings respondent would spend preparing the
productive meeting. with CDER annually and approximately information package in accordance with
The collection of information 175 respondents request approximately the guidance, is estimated to be
described in the guidance reflects the 264 formal meetings with CBER approximately 18 hours. Based on
current and past practice of sponsors annually regarding the development and FDA’s experience, the Agency expects it
and applicants to submit meeting review of a PDUFA product. The hours will take respondents this amount of
requests as amendments to INDs, NDAs, per response, which is the estimated time to gather and copy brief statements
and BLAs and to submit background number of hours that a respondent about the product, a description of the
information prior to a scheduled would spend preparing the information details for the anticipated meeting, and
meeting. Agency regulations currently to be submitted with a meeting request data and information that generally
permit such requests and recommend in accordance with the guidance, is would already have been compiled for
the submission of an information estimated to be approximately 10 hours. submission to the Agency.
package before an end-of-phase 2 Based on FDA’s experience, the Agency As stated earlier, the guidance
meeting (§§ 312.47(b)(1)(ii) and expects it will take respondents this provides information on how the
(b)(1)(iv)) and a pre-NDA meeting amount of time to gather and copy brief Agency will interpret and apply section
(§ 312.47(b)(2)). statements about the product and a
Description of Respondents: A 119(a) of the FDAMA, specific PDUFA
description of the purpose and details of goals for the management of meetings
sponsor or applicant for a drug or the meeting.
biological product who requests a associated with the review of human
formal meeting with the Agency IV. Information Package drug applications for PDUFA products,
regarding the development and review and provisions of existing regulations
of a PDUFA product. Based on data collected from the describing certain meetings (§§ 312.47
Burden Estimate: Provided in this review divisions and offices within and 312.82). The information collection
document is an estimate of the annual CDER and CBER, FDA estimates that provisions in § 312.47 concerning end-
reporting burden for the submission of approximately 959 respondents of-phase 2 meetings and pre-NDA
meeting requests and information submitted approximately 1,901 meetings have been approved by OMB
packages under the guidance. information packages to CDER annually control number 0910–0014. However,
and approximately 142 respondents the guidance provides additional
III. Request for a Formal Meeting submitted approximately 193 recommendations for submitting
Based on data collected from the information packages to CBER annually information to FDA in support of a
review divisions and offices within prior to a formal meeting regarding the meeting request. As a result, FDA is
CDER and CBER, FDA estimates that development and review of a PDUFA submitting for OMB approval these
approximately 1,099 sponsors and product. The hours per response, which additional estimates.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Meeting requests and information packages responses per burden per Total hours
respondents responses
respondent response
Meeting Requests:
CDER ............................................................................ 1,099 2.15 2,366 10 23,660
CBER ............................................................................ 175 1.51 264 10 2,640
Total ....................................................................... ........................ ........................ ........................ ........................ 26,300
Information Packages:
CDER ............................................................................ 959 1.99 1,901 18 34,218
CBER ............................................................................ 142 1.36 193 18 3,474
Total ....................................................................... ........................ ........................ ........................ ........................ 37,692
Grand Total .................................................... ........................ ........................ ........................ ........................ 63,992
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 14, 2015. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Leslie Kux, HUMAN SERVICES Administration (FDA) is announcing
Associate Commissioner for Policy. that a proposed collection of
Food and Drug Administration information has been submitted to the
[FR Doc. 2015–12170 Filed 5–19–15; 8:45 am]
Office of Management and Budget
BILLING CODE 4164–01–P
[Docket No. FDA–2008–N–0397] (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Agency Information Collection
Activities; Submission for Office of DATES: Fax written comments on the
mstockstill on DSK4VPTVN1PROD with NOTICES
Management and Budget Review; collection of information by June 19,
Comment Request; State Enforcement 2015.
Notifications ADDRESSES: To ensure that comments on
AGENCY: Food and Drug Administration, the information collection are received,
HHS. OMB recommends that written
comments be faxed to the Office of
ACTION: Notice.
Information and Regulatory Affairs,
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Document Created: 2018-02-21 10:29:45
Document Modified: 2018-02-21 10:29:45
| 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 the collection of information by July 20, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 29010 |
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