80 FR 60913 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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 195 (October 8, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 195 (October 8, 2015)
| Page Range | 60913-60915 | |
| FR Document | 2015-25624 |
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)] [Notices] [Pages 60913-60915] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25624] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0247] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 9, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2012-N-0247 for ``Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 [[Page 60914]] 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0429. 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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) (Pub. L. 105-115), 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), (1)(iv), and (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); [[Page 60915]] 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. 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 (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. In the Federal Register of May 20, 2015 (80 FR 29010), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. As stated earlier, the guidance provides information on how the Agency will interpret and apply section 119(a) of 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: October 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25624 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60913
8 These notifications recommend the submission of Form FDA 3480.
9 These notifications recommend the submission of Form FDA 3480A.
The estimates in table 1 are based on petition under § 171.1, for a total of one solely responsible for ensuring that your
our current experience with the food response. We calculate a reporting comment does not include any
contact substance notification program burden of 10,995 hours per response, for confidential information that you or a
and informal communication with a total burden of 10,995 hours. third party may not wish to be posted,
industry. Finally, in row 9, we estimate 10 such as medical information, your or
Beginning in row 1, we estimate 10 respondents will utilize the anyone else’s Social Security number, or
respondents will submit 2 notifications recommendations in the guidance confidential business information, such
annually for food contact substance document entitled, ‘‘Use of Recycled as a manufacturing process. Please note
formulations (Form FDA 3479), for a Plastics in Food Packaging: Chemistry that if you include your name, contact
total of 20 responses. We calculate a Considerations,’’ to develop the information, or other information that
reporting burden of 2 hours per additional information for one such identifies you in the body of your
response, for a total of 40 hours. In row submission annually, for a total of 10 comments, that information will be
2 we estimate six respondents. We responses. We calculate a reporting posted on http://www.regulations.gov.
believe the hourly burden for preparing burden of 25 hours per response, for a • If you want to submit a comment
these notifications will primarily consist total burden of 250 hours. with confidential information that you
of the manufacturer or supplier Dated: October 2, 2015. do not wish to be made available to the
completing Form FDA 3480, verifying Leslie Kux, public, submit the comment as a
that a previous notification is effective, written/paper submission and in the
Associate Commissioner for Policy.
and preparing necessary documentation. manner detailed (see ‘‘Written/Paper
[FR Doc. 2015–25625 Filed 10–7–15; 8:45 am]
We estimate one submission for each Submissions’’ and ‘‘Instructions’’).
BILLING CODE 4164–01–P
respondent, for a total of six responses.
Written/Paper Submissions
We calculate a reporting burden of 25
hours per response, for a total of 150 Submit written/paper submissions as
DEPARTMENT OF HEALTH AND follows:
hours.
In rows 3, 4, and 5, we identify three HUMAN SERVICES • Mail/Hand delivery/Courier (for
tiers of FCNs that reflect different levels Food and Drug Administration written/paper submissions): Division of
of burden applicable to the respective Dockets Management (HFA–305), Food
information collection items (denoted as [Docket No. FDA–2012–N–0247] and Drug Administration, 5630 Fishers
Categories C, D, and E). We estimate 6 Lane, Rm. 1061, Rockville, MD 20852.
respondents will submit 2 Category C Agency Information Collection • For written/paper comments
submissions annually, for a total of 12 Activities; Proposed Collection; submitted to the Division of Dockets
responses. We calculate a reporting Submission for Office of Management Management, FDA will post your
burden of 120 hours per response, for a and Budget Review; Guidance for comment, as well as any attachments,
total burden of 1,440 hours. We estimate Industry on Formal Meetings With except for information submitted,
42 respondents will submit 2 Category Sponsors and Applicants for marked and identified, as confidential,
D submissions annually, for a total of 84 Prescription Drug User Fee Act if submitted as detailed in
responses. We calculate a reporting Products ‘‘Instructions.’’
burden of 150 hours per response, for a AGENCY: Food and Drug Administration, Instructions: All submissions received
total burden of 12,600 hours. We HHS. must include the Docket No. FDA–
estimate 38 respondents will submit 1 ACTION: Notice. 2012–N–0247 for ‘‘Agency Information
Category E submission annually, for a Collection Activities; Proposed
total of 38 responses. We calculate a SUMMARY: The Food and Drug Collection; Submission for Office of
reporting burden of 150 hours per Administration (FDA) is announcing Management and Budget Review;
response, for a total burden of 5,700 that a proposed collection of Guidance for Industry on Formal
hours. information has been submitted to the Meetings With Sponsors and Applicants
In row 6, we estimate 190 respondents Office of Management and Budget for PDUFA Products.’’
will submit information to a pre- (OMB) for review and clearance under Received comments will be placed in
notification consultation or a master file the Paperwork Reduction Act of 1995. the docket and, except for those
in support of FCN submission using DATES: Fax written comments on the submitted as ‘‘Confidential
Form FDA 3480. We calculate a collection of information by November Submissions,’’ publicly viewable at
reporting burden of 0.5 hours per 9, 2015. http://www.regulations.gov or at the
response, for a total burden of 95 hours. ADDRESSES: You may submit comments Division of Dockets Management
In row 7 we estimate 100 respondents as follows: between 9 a.m. and 4 p.m., Monday
will submit an amendment (Form FDA through Friday.
3480A) to a substantive or non- Electronic Submissions • Confidential Submissions—To
substantive request of additional Submit electronic comments in the submit a comment with confidential
information to an incomplete FCN following way: information that you do not wish to be
• Federal eRulemaking Portal: http://
mstockstill on DSK4VPTVN1PROD with NOTICES
submission, an amendment to a pre- made publicly available, submit your
notification consultation, or an www.regulations.gov. Follow the comments only as a written/paper
amendment to a master file in support instructions for submitting comments. submission. You should submit two
of an FCN. We calculate a reporting Comments submitted electronically, copies total. One copy will include the
burden of 0.5 hours per response, for a including attachments, to http:// information you claim to be confidential
total burden of 50 hours. www.regulations.gov will be posted to with a heading or cover note that states
In row 8, we estimate one respondent the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
will submit one indirect food additive comment will be made public, you are CONFIDENTIAL INFORMATION’’. The
VerDate Sep<11>2014 18:42 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1](https://thefederalregister.org/doc/80_FR_61108/page/1.svg)
![Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60915
• a summary of preclinical data that meeting requests and information is the estimated number of hours that a
will be discussed (as appropriate); and packages under the guidance. respondent would spend preparing the
• chemistry, manufacturing, and information package in accordance with
controls information that may be III. Request for a Formal Meeting
the guidance, is estimated to be
discussed (as appropriate). Based on data collected from the approximately 18 hours. Based on
The purpose of the information review divisions and offices within FDA’s experience, the Agency expects it
package is to provide Agency staff the CDER and CBER, FDA estimates that will take respondents this amount of
opportunity to adequately prepare for approximately 1,099 sponsors and time to gather and copy brief statements
the meeting, including the review of applicants (respondents) request about the product, a description of the
relevant data concerning the product. approximately 2,366 formal meetings details for the anticipated meeting, and
Although FDA reviews similar with CDER annually and approximately
data and information that generally
information in the meeting request, the 175 respondents request approximately
would already have been compiled for
information package should provide 264 formal meetings with CBER
submission to the Agency.
updated data that reflect the most annually regarding the development and
current and accurate information review of a PDUFA product. The hours In the Federal Register of May 20,
available to the sponsor or applicant. per response, which is the estimated 2015 (80 FR 29010), FDA published a
The Agency finds that reviewing such number of hours that a respondent 60-day notice requesting public
information is critical to achieving a would spend preparing the information comment on the proposed collection of
productive meeting. to be submitted with a meeting request information. No comments were
The collection of information in accordance with the guidance, is received.
described in the guidance reflects the estimated to be approximately 10 hours. As stated earlier, the guidance
current and past practice of sponsors Based on FDA’s experience, the Agency provides information on how the
and applicants to submit meeting expects it will take respondents this Agency will interpret and apply section
requests as amendments to INDs, NDAs, amount of time to gather and copy brief 119(a) of FDAMA, specific PDUFA goals
and BLAs and to submit background statements about the product and a
for the management of meetings
information prior to a scheduled description of the purpose and details of
associated with the review of human
meeting. Agency regulations currently the meeting.
permit such requests and recommend drug applications for PDUFA products,
IV. Information Package and provisions of existing regulations
the submission of an information
package before an end-of-phase 2 Based on data collected from the describing certain meetings (§§ 312.47
meeting (§§ 312.47(b)(1)(ii) and (iv)) and review divisions and offices within and 312.82). The information collection
a pre-NDA meeting (§ 312.47(b)(2)). CDER and CBER, FDA estimates that provisions in § 312.47 concerning end-
Description of Respondents: A approximately 959 respondents of-phase 2 meetings and pre-NDA
sponsor or applicant for a drug or submitted approximately 1,901 meetings have been approved by OMB
biological product who requests a information packages to CDER annually control number 0910–0014. However,
formal meeting with the Agency and approximately 142 respondents the guidance provides additional
regarding the development and review submitted approximately 193 recommendations for submitting
of a PDUFA product. information packages to CBER annually information to FDA in support of a
Burden Estimate: Provided in this prior to a formal meeting regarding the meeting request. As a result, FDA is
document is an estimate of the annual development and review of a PDUFA submitting for OMB approval these
reporting burden for the submission of 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25624 Filed 10–7–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 E:\FR\FM\08OCN1.SGM 08OCN1](https://thefederalregister.org/doc/80_FR_61108/page/3.svg)
Document Created: 2015-12-15 08:42:43
Document Modified: 2015-12-15 08:42:43
| 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 | Fax written comments on the collection of information by November 9, 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 60913 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR