83 FR 16367 - Special Protocol Assessment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 73 (April 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 73 (April 16, 2018)
| Page Range | 16367-16369 | |
| FR Document | 2018-07871 |
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)] [Notices] [Pages 16367-16369] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07871] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1174] Special Protocol Assessment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Special Protocol Assessment.'' This guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research for special protocol assessment (SPA). This guidance is intended to improve the quality of requests for SPAs and accompanying submission materials, and the quality of the resulting interactions between sponsors and FDA. This guidance finalizes the draft guidance of the same name issued May 4, 2016, and replaces the guidance of the same name issued May 17, 2002. DATES: The announcement of the guidance is published in the Federal Register on April 16, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [[Page 16368]] For written/paper comments submitted to the Dockets Management Staff, 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-D-1174 for ``Special Protocol Assessment; Guidance for Industry.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Special Protocol Assessment.'' SPA is a process by which sponsors may request to meet with FDA to reach agreement on the design and size of certain trials, clinical studies, or animal studies to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. After completing the SPA review, FDA issues a letter including comments from the review team, agreement or nonagreement with the proposed protocol, and answers to the sponsor's relevant questions. Section 119 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) amended section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)) and directed FDA to meet with sponsors who request to meet, provided certain conditions are met, to reach agreement on the design and size of the well-controlled clinical trials intended to form the primary basis for a demonstration of effectiveness in a marketing application submitted under section 505(b) of the FD&C Act or section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). These provisions subsequently were amended in section 7002(d)(1) of the Biologics Price Competition and Innovation Act of 2009 to include any necessary clinical study or studies for biosimilar biological product applications under section 351(k) of the PHS Act. In 2013, the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 further amended the SPA provisions to provide for SPA agreements regarding animal and associated clinical trials conducted in support of applications for products developed under 21 CFR part 314, subpart I, and 21 CFR part 601, subpart H (the animal rule). Such marketing applications include new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements to approved NDAs and BLAs. In conjunction with the reauthorization of the prescription drug user fee program in FDAMA (Prescription Drug User Fee Act (PDUFA) II),\1\ and with the Biosimilar User Fee Act of 2012 (BsUFA), enacted as part of the Food and Drug Administration Safety and Innovation Act, FDA agreed to specific performance goals (PDUFA goals and BsUFA goals,\2\ respectively) for SPA. Per section 505(b)(5)(B) of the FD&C Act, the PDUFA goals, and the BsUFA goals, the following protocols are eligible for SPA: (1) Animal carcinogenicity protocols; (2) drug substance and drug product stability protocols; (3) animal efficacy protocols for studies intended to provide primary evidence of effectiveness required for approval or for licensure for products developed under the animal rule; (4) protocols for trials intended to form the primary basis of an efficacy claim; and (5) clinical studies necessary to prove biosimilarity and/or interchangeability. --------------------------------------------------------------------------- \1\ FDA first agreed to specific PDUFA goals for SPA in November 1997 in conjunction with PDUFA II, the reauthorization of the Prescription Drug User Fee Act of 1992. The PDUFA II goals are described in ``PDUFA Reauthorization Performance Goals and Procedures,'' an enclosure to a letter dated November 12, 1997, from the Secretary of Health and Human Services, Donna E. Shalala, to Senator James M. Jeffords (https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm143135.htm). The program has been reauthorized every 5 years; the most recent goals letter is available on the FDA website at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm. \2\ The BsUFA goals were later updated, in conjunction with the Biosimilar User Fee Amendments of 2017. --------------------------------------------------------------------------- This guidance finalizes the draft guidance of the same name issued May 4, 2016, and replaces the guidance of the same name issued May 17, 2002. Changes were made from the 2016 draft guidance to improve clarity and readability. This guidance is being issued consistent with FDA's good guidance [[Page 16369]] practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on SPA. 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. This guidance is not subject to Executive Order 12866. 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 collections of information referred to in the guidance entitled ``Special Protocol Assessment'' have been approved under OMB control number 0910-0470. The collections of information for Form FDA 1571 have been approved under OMB control number 0910-0014. III. Electronic Access Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: April 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07871 Filed 4-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16367
I. Background number 0910–0485; the collections of SUMMARY: The Food and Drug
FDA is announcing the availability of information in 21 CFR parts 50 and 56 Administration (FDA or Agency) is
a draft guidance for industry entitled have been approved under OMB control announcing the availability of a
‘‘Investigational In Vitro Diagnostics in number 0910–0755; the collections of guidance for industry entitled ‘‘Special
Oncology Trials: Streamlined information in 21 CFR 56.115 have been Protocol Assessment.’’ This guidance
Submission Process for Study Risk approved under OMB control number provides information about the
Determination.’’ This guidance, 0910–0130; the collections of procedures and general policies adopted
developed by the Oncology Center of information in 21 CFR 50.23 have been by the Center for Drug Evaluation and
Excellence, CDER, CBER, and CDRH at approved under OMB control number Research and the Center for Biologics
FDA, describes an optional streamlined 0910–0586; the collections of Evaluation and Research for special
submission process to determine information in 21 CFR part 812 have protocol assessment (SPA). This
whether an investigational in vitro been approved under OMB control guidance is intended to improve the
diagnostic in an oncology clinical trial number 0910–0078; the collections of quality of requests for SPAs and
under an IND (an oncology co- information in 21 CFR part 820 have accompanying submission materials,
development program) is significant been approved under OMB control and the quality of the resulting
risk. In the traditional submission number 0910–0073; the collections of interactions between sponsors and FDA.
process, many sponsors submitted a information in 21 CFR part 312 have This guidance finalizes the draft
study risk determination Q-submission been approved under OMB control guidance of the same name issued May
to CDRH and an IND to the appropriate number 0910–0014; and the collections 4, 2016, and replaces the guidance of
center (CBER or CDER). In the of information in 21 CFR part 314 have the same name issued May 17, 2002.
streamlined process, all information been approved under OMB control DATES: The announcement of the
regarding the oncology co-development number 0910–0001. The collections of guidance is published in the Federal
program (including investigational in information in the guidance document Register on April 16, 2018.
vitro diagnostic information) is initially titled ‘‘Requests for Feedback on ADDRESSES: You may submit either
submitted to the IND. CBER or CDER Medical Device Submissions: The Pre- electronic or written comments on
works with CDRH to determine whether Submission Program and Meetings with Agency guidances at any time as
the in vitro diagnostic is significant risk. Food and Drug Administration Staff’’ follows:
Initially, FDA plans to implement the (available at https://www.fda.gov/ucm/
streamlined submission process for groups/fdagov-public/@fdagov-meddev- Electronic Submissions
oncology-related products, because FDA gen/documents/document/ Submit electronic comments in the
has received the greatest number of co- ucm311176.pdf) have been approved following way:
development submissions in this under OMB control number 0910–0756. • Federal eRulemaking Portal:
disease area and has the most III. Electronic Access https://www.regulations.gov. Follow the
experience evaluating whether the in instructions for submitting comments.
vitro diagnostic is significant risk. Persons with access to the internet Comments submitted electronically,
However, FDA is interested in receiving may obtain the draft guidance at https:// including attachments, to https://
comments on whether the streamlined www.fda.gov/Drugs/ www.regulations.gov will be posted to
submission process should be extended GuidanceCompliance the docket unchanged. Because your
to other disease areas in the future. RegulatoryInformation/Guidances/ comment will be made public, you are
This draft guidance is being issued default.htm, https://www.fda.gov/ solely responsible for ensuring that your
consistent with FDA’s good guidance BiologicsBloodVaccines/ comment does not include any
practices regulation (21 CFR 10.115). GuidanceCompliance confidential information that you or a
This draft guidance is not final nor is it RegulatoryInformation/Guidances/ third party may not wish to be posted,
in effect at this time. The draft guidance, default.htm, https://www.fda.gov/ such as medical information, your or
when finalized, will represent the MedicalDevices/DeviceRegulation anyone else’s Social Security number, or
current thinking of FDA on a andGuidance/GuidanceDocuments/ confidential business information, such
streamlined submission process for default.htm, or https:// as a manufacturing process. Please note
study risk determination for in vitro www.regulations.gov. that if you include your name, contact
diagnostics in oncology trials. It does Dated: April 9, 2018. information, or other information that
not establish any rights for any person Leslie Kux, identifies you in the body of your
and is not binding on FDA or the public. Associate Commissioner for Policy. comments, that information will be
You can use an alternative approach if [FR Doc. 2018–07812 Filed 4–13–18; 8:45 am] posted on https://www.regulations.gov.
it satisfies the requirements of the BILLING CODE 4164–01–P
• If you want to submit a comment
applicable statutes and regulations. This with confidential information that you
guidance is not subject to Executive do not wish to be made available to the
Order 12866. DEPARTMENT OF HEALTH AND public, submit the comment as a
HUMAN SERVICES written/paper submission and in the
II. The Paperwork Reduction Act of
manner detailed (see ‘‘Written/Paper
1995 Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
This guidance refers to currently
approved collections of information. [Docket No. FDA–2016–D–1174] Written/Paper Submissions
srobinson on DSK3G9T082PROD with NOTICES
These collections of information are Submit written/paper submissions as
subject to review by the Office of Special Protocol Assessment; follows:
Management and Budget (OMB) under Guidance for Industry; Availability • Mail/Hand Delivery/Courier (for
the Paperwork Reduction Act of 1995 AGENCY: Food and Drug Administration, written/paper submissions): Dockets
(44 U.S.C. 3501–3520). The collections HHS. Management Staff (HFA–305), Food and
of information in 21 CFR part 809 have Drug Administration, 5630 Fishers
ACTION: Notice of availability.
been approved under OMB control Lane, Rm. 1061, Rockville, MD 20852.
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![Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16369
practices regulation (21 CFR 10.115). guidance to firms that manufacture, 2018–D–1189 for ‘‘Highly Concentrated
The guidance represents the current market, or distribute dietary supplement Caffeine in Dietary Supplements;
thinking of FDA on SPA. It does not products that contain pure or highly Guidance for Industry; Availability.’’
establish any rights for any person and concentrated caffeine, or are considering Received comments will be placed in
is not binding on FDA or the public. doing so. This guidance should help the docket and, except for those
You can use an alternative approach if such parties determine whether their submitted as ‘‘Confidential
it satisfies the requirements of the products are or would be adulterated Submissions,’’ publicly viewable at
applicable statutes and regulations. This under the Federal Food, Drug, and https://www.regulations.gov or at the
guidance is not subject to Executive Cosmetic Act (FD&C Act) and to help Dockets Management Staff between 9
Order 12866. them understand how to reduce the a.m. and 4 p.m., Monday through
likelihood that their products will be Friday.
II. The Paperwork Reduction Act of • Confidential Submissions—To
considered adulterated.
1995 submit a comment with confidential
DATES: The announcement of the
This guidance refers to previously guidance is published in the Federal information that you do not wish to be
approved collections of information that Register on April 16, 2018. made publicly available, submit your
are subject to review by the Office of ADDRESSES: You may submit either comments only as a written/paper
Management and Budget (OMB) under electronic or written comments on submission. You should submit two
the Paperwork Reduction Act of 1995 Agency guidances at any time as copies total. One copy will include the
(44 U.S.C. 3501–3520). The collections follows: information you claim to be confidential
of information referred to in the with a heading or cover note that states
guidance entitled ‘‘Special Protocol Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Assessment’’ have been approved under Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ We
OMB control number 0910–0470. The following way: will review this copy, including the
collections of information for Form FDA • Federal eRulemaking Portal: claimed confidential information, in our
1571 have been approved under OMB https://www.regulations.gov. Follow the consideration of comments. The second
control number 0910–0014. instructions for submitting comments. copy, which will have the claimed
Comments submitted electronically, confidential information redacted/
III. Electronic Access
including attachments, to https:// blacked out, will be available for public
Persons with access to the internet www.regulations.gov will be posted to viewing and posted on https://
may obtain the guidance at https:// the docket unchanged. Because your www.regulations.gov. Submit both
www.fda.gov/Drugs/ comment will be made public, you are copies to the Dockets Management Staff.
GuidanceCompliance solely responsible for ensuring that your If you do not wish your name and
RegulatoryInformation/Guidances/ comment does not include any contact information to be made publicly
default.htm, https://www.fda.gov/ confidential information that you or a available, you can provide this
BiologicsBloodVaccines/ third party may not wish to be posted, information on the cover sheet and not
GuidanceCompliance such as medical information, your or in the body of your comments and you
RegulatoryInformation/default.htm, or anyone else’s Social Security number, or must identify this information as
https://www.regulations.gov. confidential business information, such ‘‘confidential.’’ Any information marked
Dated: April 11, 2018. as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Leslie Kux, that if you include your name, contact except in accordance with 21 CFR 10.20
Associate Commissioner for Policy. information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
[FR Doc. 2018–07871 Filed 4–13–18; 8:45 am]
comments, that information will be of comments to public dockets, see 80
BILLING CODE 4164–01–P
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
DEPARTMENT OF HEALTH AND
do not wish to be made available to the 23389.pdf.
HUMAN SERVICES
public, submit the comment as a Docket: For access to the docket to
Food and Drug Administration written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
[Docket No. FDA–2018–D–1189] received, go to https://
Submissions’’ and ‘‘Instructions’’).
www.regulations.gov and insert the
Highly Concentrated Caffeine in Written/Paper Submissions docket number, found in brackets in the
Dietary Supplements; Guidance for heading of this document, into the
Submit written/paper submissions as
Industry; Availability ‘‘Search’’ box and follow the prompts
follows:
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
HHS. written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notice of availability. Management Staff (HFA–305), Food and Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
Administration (FDA or we) is • For written/paper comments 10.115(g)(5)).
announcing the availability of a submitted to the Dockets Management Submit written requests for single
srobinson on DSK3G9T082PROD with NOTICES
guidance for industry, ‘‘Highly Staff, FDA will post your comment, as copies of the guidance to Office of
Concentrated Caffeine in Dietary well as any attachments, except for Dietary Supplement Programs, Center
Supplements.’’ FDA considers some information submitted, marked and for Food Safety and Applied Nutrition,
dietary supplements that consist of only identified, as confidential, if submitted Food and Drug Administration, 5001
or primarily pure or highly concentrated as detailed in ‘‘Instructions.’’ Campus Dr., College Park, MD 20740.
caffeine to be adulterated. FDA is Instructions: All submissions received Send two self-addressed adhesive labels
issuing this document to provide must include the Docket No. FDA– to assist that office in processing your
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Document Created: 2018-04-14 02:19:11
Document Modified: 2018-04-14 02:19:11
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on April 16, 2018. | |
| Contact | Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 16367 |
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