81 FR 81776 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81776-81778 | |
| FR Document | 2016-27840 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81776-81778] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27840] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3535] Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment 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 in the guidance for industry on special protocol assessment. DATES: Submit either electronic or written comments on the collection of information by January 17, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-2016-N-3535 for ``Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the 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 Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the 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 https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 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 [[Page 81777]] 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 Special Protocol Assessment--OMB Control Number 0910-0470--Extension The ``Guidance for Industry on Special Protocol Assessment'' describes Agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance describes procedures for sponsors to request special protocol assessment and for the Agency to act on such requests. The guidance provides information on how the Agency interprets and applies provisions of the Food and Drug Administration Modernization Act of 1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA) goals for special protocol assessment associated with the development and review of PDUFA products. The guidance describes the following two collections of information: (1) The submission of a notice of intent to request special protocol assessment of a carcinogenicity protocol and (2) the submission of a request for special protocol assessment. I. Notification for a Carcinogenicity Protocol As described in the guidance, a sponsor interested in Agency assessment of a carcinogenicity protocol should notify the appropriate division in FDA's Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) of an intent to request special protocol assessment at least 30 days prior to submitting the request. With such notification, the sponsor should submit relevant background information so that the Agency may review reference material related to carcinogenicity protocol design prior to receiving the carcinogenicity protocol. II. Request for Special Protocol Assessment The guidance asks that a request for special protocol assessment be submitted as an amendment to the investigational new drug application (IND) for the underlying product and that it be submitted to the Agency in triplicate with Form FDA 1571 attached. The guidance also suggests that the sponsor submit the cover letter to a request for special protocol assessment via fax to the appropriate division in CDER or CBER. Agency regulations (21 CFR 312.23(d)) state that information provided to the Agency as part of an IND is to be submitted in triplicate and with the appropriate cover form, Form FDA 1571. An IND is submitted to FDA under existing regulations in part 312 (21 CFR part 312), which specifies the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of investigational drugs and biological products. The information collection requirements resulting from the preparation and submission of an IND under part 312 have been estimated by FDA and the reporting and recordkeeping burden has been approved by OMB under OMB control number 0910-0014. FDA suggests that the cover letter to the request for special protocol assessment be submitted via fax to the appropriate division in CDER or CBER to enable Agency staff to prepare for the arrival of the protocol for assessment. The Agency recommends that a request for special protocol assessment be submitted as an amendment to an IND for two reasons: (1) To ensure that each request is kept in the administrative file with the entire IND 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 appropriate Agency official to monitor progress on the evaluation of the protocol and to ensure that appropriate steps will be taken in a timely manner. The guidance recommends that the following information should be submitted to the appropriate Center with each request for special protocol assessment so that the Center may quickly and efficiently respond to the request: Questions to the Agency concerning specific issues regarding the protocol; and All data, assumptions, and information needed to permit an adequate evaluation of the protocol, including: (1) The role of the study in the overall development of the drug; (2) information supporting the proposed trial, including power calculations, the choice of study endpoints, and other critical design features; (3) regulatory outcomes that could be supported by the results of the study; (4) final labeling that could be supported by the results of the study; and (5) for a stability protocol, product characterization and relevant manufacturing data. Description of Respondents: A sponsor, applicant, or manufacturer of a drug or biologic product regulated by the Agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act (42 U.S.C. 262) who requests special protocol assessment. Burden Estimate: Table 1 of this document provides an estimate of the annual reporting burden for notifications for a carcinogenicity protocol and requests for a special protocol assessment. Notification for a Carcinogenicity Protocol: Based on the number of notifications for carcinogenicity protocols and the number of carcinogenicity protocols currently submitted to CDER and CBER, CDER estimates that it will receive approximately 52 notifications of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately 28 sponsors. CBER estimates that it will receive approximately one notification of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately one sponsor. The hours per response, which is the estimated number of hours that a sponsor would spend preparing the notification and background information to be submitted in accordance with the guidance, is estimated to be approximately 8 hours. Requests for Special Protocol Assessment: Based on the number of requests for special protocol assessment currently submitted to CDER and CBER, CDER estimates that it will receive approximately 211 requests for special protocol assessment per year from approximately 112 sponsors. CBER estimates that it will receive approximately nine requests from approximately seven sponsors. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for special protocol assessment, including the time it takes to gather and copy questions to be posed to the Agency regarding the protocol and data, assumptions, and information needed to permit an adequate evaluation of the protocol. Based on the Agency's experience with these submissions, FDA estimates approximately 15 hours on average would be needed per response. FDA estimates the burden of this collection as follows: [[Page 81778]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Information collection activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Notification for Carcinogenicity 29 1.8 53 8 424 Protocols...................... Requests for Special Protocol 119 1.8 220 15 3,300 Assessment..................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 3,724 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection. Dated: November 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27840 Filed 11-17-16; 8:45 am] BILLING CODE 4164-01-P
![81776 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
requirements of the applicable statutes comment does not include any both copies to the Division of Dockets
and regulations. confidential information that you or a Management. If you do not wish your
third party may not wish to be posted, name and contact information to be
II. Electronic Access
such as medical information, your or made publicly available, you can
Persons with access to the Internet anyone else’s Social Security number, or provide this information on the cover
may obtain the guidance at either http:// confidential business information, such sheet and not in the body of your
www.fda.gov/Drugs/Guidance as a manufacturing process. Please note comments and you must identify this
ComplianceRegulatoryInformation/ that if you include your name, contact information as ‘‘confidential.’’ Any
Guidances/default.htm or http:// information, or other information that information marked as ‘‘confidential’’
www.regulations.gov. identifies you in the body of your will not be disclosed except in
Dated: November 14, 2016. comments, that information will be accordance with 21 CFR 10.20 and other
Leslie Kux, posted on https://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
Associate Commissioner for Policy.
with confidential information that you comments to public dockets, see 80 FR
[FR Doc. 2016–27761 Filed 11–17–16; 8:45 am] do not wish to be made available to the 56469, September 18, 2015, or access
BILLING CODE 4164–01–P public, submit the comment as a the information at: http://www.fda.gov/
written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
HUMAN SERVICES
Written/Paper Submissions read background documents or the
Food and Drug Administration electronic and written/paper comments
Submit written/paper submissions as received, go to https://
[Docket No. FDA–2016–N–3535] follows: www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for
docket number, found in brackets in the
Agency Information Collection written/paper submissions): Division of
heading of this document, into the
Activities: Proposed Collection; Dockets Management (HFA–305), Food
‘‘Search’’ box and follow the prompts
Comment Request; Guidance for and Drug Administration, 5630 Fishers
and/or go to the Division of Dockets
Industry on Special Protocol Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Management, 5630 Fishers Lane, Rm.
Assessment
submitted to the Division of Dockets 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Management, FDA will post your FOR FURTHER INFORMATION CONTACT: FDA
HHS. comment, as well as any attachments, PRA Staff, Office of Operations, Food
ACTION: Notice. except for information submitted, and Drug Administration, Three White
marked and identified, as confidential, Flint North, 11601 Landsdown St., 10A–
SUMMARY: The Food and Drug 12M, North Bethesda, MD 20852,
if submitted as detailed in
Administration (FDA) is announcing an ‘‘Instructions.’’ PRAStaff@fda.hhs.gov.
opportunity for public comment on the Instructions: All submissions received SUPPLEMENTARY INFORMATION: Under the
proposed collection of certain must include the Docket No. FDA– PRA (44 U.S.C. 3501–3520), Federal
information by the Agency. Under the 2016–N–3535 for ‘‘Agency Information Agencies must obtain approval from the
Paperwork Reduction Act of 1995 (the Collection Activities: Proposed Office of Management and Budget
PRA), Federal Agencies are required to Collection; Comment Request; Guidance (OMB) for each collection of
publish notice in the Federal Register for Industry on Special Protocol information they conduct or sponsor.
concerning each proposed collection of Assessment.’’ Received comments will ‘‘Collection of information’’ is defined
information, including each proposed be placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR
extension of an existing collection of those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
information, and to allow 60 days for Submissions,’’ publicly viewable at or requirements that members of the
public comment in response to the https://www.regulations.gov or at the public submit reports, keep records, or
notice. This notice solicits comments on Division of Dockets Management provide information to a third party.
the information collection in the between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
guidance for industry on special through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
protocol assessment. • Confidential Submissions—To Agencies to provide a 60-day notice in
DATES: Submit either electronic or submit a comment with confidential the Federal Register concerning each
written comments on the collection of information that you do not wish to be proposed collection of information,
information by January 17, 2017. made publicly available, submit your including each proposed extension of an
ADDRESSES: You may submit comments comments only as a written/paper existing collection of information,
as follows: submission. You should submit two before submitting the collection to OMB
copies total. One copy will include the for approval. To comply with this
Electronic Submissions information you claim to be confidential requirement, FDA is publishing notice
Submit electronic comments in the with a heading or cover note that states of the proposed collection of
following way: ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
• Federal eRulemaking Portal: https:// CONFIDENTIAL INFORMATION.’’ The With respect to the following
www.regulations.gov. Follow the Agency will review this copy, including collection of information, FDA invites
mstockstill on DSK3G9T082PROD with NOTICES
instructions for submitting comments. the claimed confidential information, in comments on these topics: (1) Whether
Comments submitted electronically, its consideration of comments. The the proposed collection of information
including attachments, to https:// second copy, which will have the is necessary for the proper performance
www.regulations.gov will be posted to claimed confidential information of FDA’s functions, including whether
the docket unchanged. Because your redacted/blacked out, will be available the information will have practical
comment will be made public, you are for public viewing and posted on utility; (2) the accuracy of FDA’s
solely responsible for ensuring that your https://www.regulations.gov. Submit estimate of the burden of the proposed
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![81778 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average bur-
Number of Total annual
Information collection activity responses per den per re- Total hours
respondents responses
respondent sponse
Notification for Carcinogenicity Protocols ............................ 29 1.8 53 8 424
Requests for Special Protocol Assessment ........................ 119 1.8 220 15 3,300
Total .............................................................................. ........................ ........................ ........................ ........................ 3,724
1 There are no capital costs or operating and maintenance costs associated with this collection.
Dated: November 15, 2016. Electronic Submissions those submitted as ‘‘Confidential
Leslie Kux, Submit electronic comments in the Submissions,’’ publicly viewable at
Associate Commissioner for Policy. following way: http://www.regulations.gov or at the
[FR Doc. 2016–27840 Filed 11–17–16; 8:45 am] • Federal eRulemaking Portal: http:// Division of Dockets Management
BILLING CODE 4164–01–P www.regulations.gov. Follow the between 9 a.m. and 4 p.m., Monday
instructions for submitting comments. through Friday.
Comments submitted electronically, • Confidential Submissions—To
DEPARTMENT OF HEALTH AND including attachments, to http:// submit a comment with confidential
HUMAN SERVICES www.regulations.gov will be posted to information that you do not wish to be
the docket unchanged. Because your made publicly available, submit your
Food and Drug Administration comment will be made public, you are comments only as a written/paper
solely responsible for ensuring that your submission. You should submit two
[Docket No. FDA–2016–D–3456] comment does not include any copies total. One copy will include the
confidential information that you or a information you claim to be confidential
Bacillus Calmette-Guerin— third party may not wish to be posted, with a heading or cover note that states
Unresponsive Nonmuscle Invasive such as medical information, your or ‘‘THIS DOCUMENT CONTAINS
Bladder Cancer: Developing Drugs and anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
Biologics for Treatment; Draft confidential business information, such Agency will review this copy, including
Guidance for Industry; Availability as a manufacturing process. Please note the claimed confidential information, in
that if you include your name, contact its consideration of comments. The
AGENCY: Food and Drug Administration, second copy, which will have the
HHS. information, or other information that
identifies you in the body of your claimed confidential information
ACTION: Notice of availability. comments, that information will be redacted/blacked out, will be available
posted on http://www.regulations.gov. for public viewing and posted on http://
SUMMARY: Summary: The Food and Drug • If you want to submit a comment www.regulations.gov. Submit both
Administration (FDA or Agency) is with confidential information that you copies to the Division of Dockets
announcing the availability of a draft do not wish to be made available to the Management. If you do not wish your
guidance for industry entitled ‘‘Bacillus public, submit the comment as a name and contact information to be
Calmette-Guerin (BCG)—Unresponsive written/paper submission and in the made publicly available, you can
Nonmuscle Invasive Bladder Cancer: manner detailed (see ‘‘Written/Paper provide this information on the cover
Developing Drugs and Biologics for Submissions’’ and ‘‘Instructions’’). sheet and not in the body of your
Treatment.’’ The purpose of this comments and you must identify this
guidance is to assist sponsors in the Written/Paper Submissions information as ‘‘confidential.’’ Any
development of drugs and biologics to Submit written/paper submissions as information marked as ‘‘confidential’’
treat patients with a high-risk form of follows: will not be disclosed except in
bladder cancer. The alternative is • Mail/Hand delivery/Courier (for accordance with 21 CFR 10.20 and other
radical cystectomy, a surgical procedure written/paper submissions): Division of applicable disclosure law. For more
with significant morbidity and Dockets Management (HFA–305), Food information about FDA’s posting of
mortality. This guidance will help and Drug Administration, 5630 Fishers comments to public dockets, see 80 FR
overcome some of the obstacles in Lane, Rm. 1061, Rockville, MD 20852. 56469, September 18, 2015, or access
conducting the studies needed to • For written/paper comments the information at: http://www.fda.gov/
establish efficacy of drugs and biologics submitted to the Division of Dockets regulatoryinformation/dockets/
for these patients with an unmet Management, FDA will post your default.htm.
medical need. comment, as well as any attachments, Docket: For access to the docket to
DATES: Although you can comment on except for information submitted, read background documents or the
any guidance at any time (see 21 CFR marked and identified, as confidential, electronic and written/paper comments
10.115(g)(5)), to ensure that the agency if submitted as detailed in received, go to http://
considers your comment on this draft ‘‘Instructions.’’ www.regulations.gov and insert the
Instructions: All submissions received docket number, found in brackets in the
mstockstill on DSK3G9T082PROD with NOTICES
guidance before it begins work on the
final version of the guidance, submit must include the Docket No. [ FDA– heading of this document, into the
either electronic or written comments 2016–D–3456] for ‘‘BCG-Unresponsive ‘‘Search’’ box and follow the prompts
on the draft guidance by February 16, Nonmuscle Invasive Bladder Cancer: and/or go to the Division of Dockets
2017. Developing Drugs and Biologics for Management, 5630 Fishers Lane, Rm.
Treatment; Draft Guidance for Industry; 1061, Rockville, MD 20852.
ADDRESSES: You may submit comments Availability.’’ Received comments will Submit written requests for single
as follows: be placed in the docket and, except for copies of the draft guidance to the
VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1](https://thefederalregister.org/doc/81_FR_81999/page/3.svg)
Document Created: 2018-02-14 08:31:34
Document Modified: 2018-02-14 08:31:34
| 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 January 17, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 81776 |
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