Interacting With the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry; Availability, 81925-81927 [2020-27813]

Download as PDF Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices electronically by 11:59 p.m. (EST) or postmarked by February 16, 2021. ADDRESSES: Submit electronic comments on the information collection request to: Peter Nye at OILPPRAComments@acl.hhs.gov. Submit written comments on the collection of information to Administration for Community Living, Washington, DC 20201, Attention: Peter Nye. FOR FURTHER INFORMATION CONTACT: Peter Nye, Administration for Community Living, Washington, DC 20201, (202) 795–7606, or peter.nye@ acl.hhs.gov. 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’’ 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, ACL is publishing a notice of the proposed collection of information set forth in this document. With respect to the following collection of information, ACL invites SUPPLEMENTARY INFORMATION: comments on our burden estimates or any other aspect of this collection of information, including: (1) Whether the proposed collection of information is necessary for the proper performance of ACL’s functions, including whether the information will have practical utility; (2) the accuracy of ACL’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates; (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. The Independent Living Services (ILS) program provides financial assistance, through formula grants, to states, the District of Columbia, Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the US Virgin Islands for expanding, and improving the provision of, independent living (IL) services. The Designated State Entity (DSE) is the agency that, on behalf of the state, receives, accounts for, and disburses funds received under Part B of the Rehabilitation Act of 1973, as amended (the Act). Funds are also made available for the provision of training and technical assistance to Statewide Independent Living Councils (SILCs). The Act permits an annual program performance report (PPR). This request 81925 is for the ILS PPR, which is submitted annually by the SILC and DSE in every state, territory, and commonwealth. ACL uses the ILS PPR to assess grantee compliance with title VII of the Act, with 45 CFR part 1329 of the Code of Federal Regulations, and with applicable provisions of the HHS Regulations at 45 CFR part 75. The ILS PPR serves as the primary basis for ACL’s monitoring activities in fulfillment of its responsibilities under sections 706 and 722 of the Act. ACL also uses the PPR to identify training and technical assistance needs for SILCs and centers for independent living. To view the data collection activity for this information collection request, please visit the ACL public input website: https://www.acl.gov/about-acl/ public-input. Estimated Program Burden ACL estimates the burden of this collection of information as follows: Fifty-six jurisdictions—specifically, the fifty states, Puerto Rico, the District of Columbia, American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the US Virgin Islands—will each complete ILS PPRs annually, and it will take an estimated thirty-five hours per jurisdiction per ILS PPR. Each jurisdiction’s SILC and DSE will collaborate to complete the ILS PPR. The fifty-six jurisdictions, combined, will take an estimated 1,960 hours per year to complete ILS PPRs. This burden estimate is based on what DSEs and SILCs have told ACL about how long filling out ILS PPRs took in previous reporting years. Respondent/data collection activity Number of respondents Responses per respondent Hours per response Total annual burden hours SILCs and DSEs .............................................................................................. 56 1 35 1,960 Dated: December 10, 2020. Mary Lazare, Principal Deputy Administrator. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2020–27734 Filed 12–16–20; 8:45 am] Food and Drug Administration [Docket No. FDA–2019–D–3679] BILLING CODE 4154–01–P Interacting With the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final SUMMARY: VerDate Sep<11>2014 18:52 Dec 16, 2020 Jkt 253001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 guidance entitled ‘‘Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products.’’ The guidance provides recommendations to sponsors and applicants on interacting with FDA on complex innovative trial design (CID) proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under the 21st Century Cures Act (Cures Act). In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and E:\FR\FM\17DEN1.SGM 17DEN1 81926 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices the types of quantitative and qualitative information that should be submitted for review. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2019. DATES: The announcement of the guidance is published in the Federal Register on December 17, 2020. 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. • 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– 2019–D–3679 for ‘‘Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential VerDate Sep<11>2014 18:52 Dec 16, 2020 Jkt 253001 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Shruti Modi, 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; or Scott Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993–0002, 301– 796–2055. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products.’’ The guidance provides recommendations to sponsors and applicants on interacting with FDA on CID proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the Cures Act (Pub. L. 114–255). In accordance with the Cures Act mandate, the guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review. In the Federal Register of September 23, 2019 (84 FR 49743), FDA announced the availability of the draft guidance of the same title dated September 2019. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Changes made to the guidance include the incorporation of example CID proposals submitted to FDA’s CID Pilot Program, and revision of the discussion of alternative operating characteristics for Bayesian trial designs. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated September 2019. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products.’’ 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 E:\FR\FM\17DEN1.SGM 17DEN1 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved collections of information found in FDA regulations. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required for this guidance. The previously approved collections of information are subject to review by the OMB under the PRA. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.regulations.gov. Dated: December 14, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27813 Filed 12–16–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–2214] Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Dry Eye: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to foster greater efficiency in drug development for this disease, which currently has few effective treatment options. The goal is to enhance clinical SUMMARY: VerDate Sep<11>2014 18:52 Dec 16, 2020 Jkt 253001 Submit either electronic or written comments on the draft guidance by March 17, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: DATES: 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 Dry Eye: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: trial data quality and to support the development of treatments for dry eye conditions. Specifically, the draft guidance provides the Agency’s current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical development programs of investigational drugs to treat dry eye conditions. 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. • 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– PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 81927 2020–D–2214 for ‘‘Dry Eye: Developing Drugs for Treatment.’’ 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81925-81927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27813]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3679]


Interacting With the Food and Drug Administration on Complex 
Innovative Trial Designs for Drugs and Biological Products; 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 final guidance entitled ``Interacting with the 
FDA on Complex Innovative Trial Designs for Drugs and Biological 
Products.'' The guidance provides recommendations to sponsors and 
applicants on interacting with FDA on complex innovative trial design 
(CID) proposals for drugs or biological products. FDA is issuing this 
guidance to satisfy, in part, a mandate under the 21st Century Cures 
Act (Cures Act). In accordance with the Cures Act mandate, this 
guidance discusses the use of novel trial designs in the development 
and regulatory review of drugs and biological products, how sponsors 
may obtain feedback on technical issues related to modeling and 
simulation, and

[[Page 81926]]

the types of quantitative and qualitative information that should be 
submitted for review. The guidance announced in this notice finalizes 
the draft guidance of the same title dated September 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on December 17, 2020.

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.
     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-2019-D-3679 for ``Interacting with the FDA on Complex Innovative 
Trial Designs for Drugs and Biological Products.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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 the office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, 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; or Scott Goldie, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 
3557, Silver Spring, MD 20993-0002, 301-796-2055.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Interacting with the FDA on Complex Innovative Trial Designs for 
Drugs and Biological Products.'' The guidance provides recommendations 
to sponsors and applicants on interacting with FDA on CID proposals for 
drugs or biological products. FDA is issuing this guidance to satisfy, 
in part, a mandate under section 3021 of the Cures Act (Pub. L. 114-
255). In accordance with the Cures Act mandate, the guidance discusses 
the use of novel trial designs in the development and regulatory review 
of drugs and biological products, how sponsors may obtain feedback on 
technical issues related to modeling and simulation, and the types of 
quantitative and qualitative information that should be submitted for 
review.
    In the Federal Register of September 23, 2019 (84 FR 49743), FDA 
announced the availability of the draft guidance of the same title 
dated September 2019. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. Changes made to the guidance include the incorporation of 
example CID proposals submitted to FDA's CID Pilot Program, and 
revision of the discussion of alternative operating characteristics for 
Bayesian trial designs. In addition, editorial changes were made to 
improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated September 2019.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Interacting with the FDA on Complex 
Innovative Trial Designs for Drugs and Biological Products.'' 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

[[Page 81927]]

requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved collections of information found in FDA 
regulations. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required for this guidance. The previously approved 
collections of information are subject to review by the OMB under the 
PRA. The collections of information in 21 CFR part 314 have been 
approved under OMB control number 0910-0001; the collections of 
information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; and the collections of information in 21 CFR part 601 
have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27813 Filed 12-16-20; 8:45 am]
BILLING CODE 4164-01-P
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