Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments, 22453-22454 [2023-07766]

Download as PDF Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices information for OTC monograph products, OTC monograph order requests, and the OTC Monograph User Fee Program have been approved under OMB control number 0910–0340. The information collections for submission of new drug applications and abbreviated new drug applications in 21 CFR part 314 are approved under OMB control number 0910–0001. The collections of information used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses under 21 CFR part 25 have been approved under OMB control number 0910–0322. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: April 7, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–07767 Filed 4–12–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–1052] Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments Food and Drug Administration, Department of Health and Human Services. ACTION: Notice; request for information and comments. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing a request for information and comments on the development of an FDA Data and Technology Strategic Plan. As part of our User Fee Program commitments and Omnibus Bill requirements, FDA will develop and publish an FDA Data and Technology Strategic Plan by September 30, 2023. This plan will define and shape the future course of FDA’s data and technology capabilities, building on the existing FDA Modernization Framework. The plan will also integrate Agency and center strategies. DATES: Submit either electronic or written comments on the request for lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:56 Apr 12, 2023 Jkt 259001 information and comments by May 15, 2023 to ensure that the Agency considers your comments before it begins work on the final version of the strategy. 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): 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– 2023–N–1052 for ‘‘FDA Data and Technology Strategic Plan.’’ 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 22453 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. FOR FURTHER INFORMATION CONTACT: Casi Alexander, Office of Digital Transformation, Food and Drug Administration, FDA Library, 5630 Fishers Lane, Rm. 1087, Rockville, MD 20857, 240–402–5171, email: Casi.Alexander@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a request for information and comments entitled ‘‘FDA Data and Technology Strategic Plan; Request for Information and Comments.’’ The Office of Digital Transformation (ODT) was established in September 2021 and reports directly to the Office of the Commissioner. ODT provides the vision and leadership in information technology, data, and cybersecurity needed to advance FDA’s mission and strategic priorities. ODT has published a series of strategy documents known as E:\FR\FM\13APN1.SGM 13APN1 22454 Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 the FDA Modernization Framework. The framework includes the Technology Modernization Action Plan, Data Modernization Action Plan, Enterprise Modernization Action Plan, Cybersecurity Modernization Action Plan, and the Leadership Modernization Action Plan. The FDA Modernization Framework aims to develop an integrated technology, data, cybersecurity, business, and leadership approach to advancing FDA’s public health mission in collaboration with industry. As part of the FDA’s fulfillment of requirements in section 3627 of the Consolidated Appropriations Act, 2023 (Pub. L. 117–328), and commitments described in section IV.A.2. of the ‘‘PDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027’’ (PDUFA VI commitment letter), FDA will work with industry as it develops a comprehensive framework for guiding the Agency’s work and allocating annual technology budgets and resources. The FDA Data and Technology Strategic Plan, covering Fiscal Years 2024–2027, will define and shape the future course of FDA’s data and technology capabilities as FDA transitions to the next phase of its journey. FDA will take an iterative approach to strategy development, starting with gathering input, then, sharing a draft of the strategic plan for comment and finally, considering inputs provided before publishing a final version of the strategic plan. FDA will focus on the outcomes to empower the Agency to meet its mission, building on the existing FDA Modernization Framework and integrating Agency and center strategies. FDA will engage internal and external stakeholders early and often throughout this process. FDA plans to incorporate stakeholder input as the Agency engages with internal and external stakeholders across the remainder of this fiscal year including through two Federal Register notices for information and comment (this one and a second one for comment on the draft strategy). Stakeholder input is crucial for developing a comprehensive plan that best meets the needs and goals of industry and the Agency. II. Requested Information and Comments Interested persons are invited to provide detailed comments to ODT (see ADDRESSES) on the following aspects of the development of FDA’s Agency-wide Data and Technology Strategic Plan. To facilitate input, FDA has developed a series of questions in this section. The questions are not meant to be exhaustive, and FDA is also interested VerDate Sep<11>2014 17:56 Apr 12, 2023 Jkt 259001 in any other pertinent information stakeholders would like to share on this topic. This feedback will help inform the Agency’s strategy development. FDA encourages stakeholders to provide the specific rationale and basis for their comments, including any available supporting data and information. FDA will publish another notice in the Federal Register requesting comments once the Data and Technology Modernization Strategy is developed. 1. What are up to three outcomes the FDA Data and Technology Strategic Plan can help you achieve, e.g., speed to market? 2. What are up to three challenges you are facing while trying to achieve these outcomes? 3. What data and technical capabilities could FDA strengthen to help support its public health mission? 4. What opportunities or risks do you foresee for the FDA Data and Technology Strategic Plan? 5. What changes or trends in your industry could impact the FDA Data and Technology Strategic Plan? 6. How might FDA best communicate and engage stakeholders in developing and implementing the strategy? Dated: April 10, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–07766 Filed 4–12–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1043] Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 person for commercial distribution; however, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. This final order exempts two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health. DATES: This order is effective May 15, 2023. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number found in brackets in the heading of this final rule 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. FOR FURTHER INFORMATION CONTACT: Jessica Gillum, 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—Reporting Requirements Under Section 510(j)(3) of the FD&C Act On March 27, 2020, the CARES Act (Pub. L. 116–136) was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019. In addition, the CARES Act included authorities to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug supply chains. Section 3112(e) of the CARES Act added new paragraph (3) to section 510(j) of the FD&C Act (21 U.S.C. 360(j)(3)), which requires that each person who registers with FDA under section 510 of the FD&C Act with regard to a drug must report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. These reporting requirements in section 510(j)(3)(A) of the FD&C Act enhance FDA’s ability to address drug shortages by enabling the Agency to identify manufacturing sites impacted and develop potential options to remediate shortage risks to the product supply chain. Under section 510(j)(3)(B) of the FD&C Act, FDA may exempt certain E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22453-22454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1052]


Food and Drug Administration Data and Technology Strategic Plan; 
Request for Information and Comments

AGENCY: Food and Drug Administration, Department of Health and Human 
Services.

ACTION: Notice; request for information and comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a request for information and comments on the development of an FDA 
Data and Technology Strategic Plan. As part of our User Fee Program 
commitments and Omnibus Bill requirements, FDA will develop and publish 
an FDA Data and Technology Strategic Plan by September 30, 2023. This 
plan will define and shape the future course of FDA's data and 
technology capabilities, building on the existing FDA Modernization 
Framework. The plan will also integrate Agency and center strategies.

DATES: Submit either electronic or written comments on the request for 
information and comments by May 15, 2023 to ensure that the Agency 
considers your comments before it begins work on the final version of 
the strategy.

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): 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-2023-N-1052 for ``FDA Data and Technology Strategic Plan.'' 
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.

FOR FURTHER INFORMATION CONTACT: Casi Alexander, Office of Digital 
Transformation, Food and Drug Administration, FDA Library, 5630 Fishers 
Lane, Rm. 1087, Rockville, MD 20857, 240-402-5171, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a request for information and 
comments entitled ``FDA Data and Technology Strategic Plan; Request for 
Information and Comments.''
    The Office of Digital Transformation (ODT) was established in 
September 2021 and reports directly to the Office of the Commissioner. 
ODT provides the vision and leadership in information technology, data, 
and cybersecurity needed to advance FDA's mission and strategic 
priorities. ODT has published a series of strategy documents known as

[[Page 22454]]

the FDA Modernization Framework. The framework includes the Technology 
Modernization Action Plan, Data Modernization Action Plan, Enterprise 
Modernization Action Plan, Cybersecurity Modernization Action Plan, and 
the Leadership Modernization Action Plan. The FDA Modernization 
Framework aims to develop an integrated technology, data, 
cybersecurity, business, and leadership approach to advancing FDA's 
public health mission in collaboration with industry.
    As part of the FDA's fulfillment of requirements in section 3627 of 
the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), and 
commitments described in section IV.A.2. of the ``PDUFA Reauthorization 
Performance Goals and Program Enhancements Fiscal Years 2023-2027'' 
(PDUFA VI commitment letter), FDA will work with industry as it 
develops a comprehensive framework for guiding the Agency's work and 
allocating annual technology budgets and resources. The FDA Data and 
Technology Strategic Plan, covering Fiscal Years 2024-2027, will define 
and shape the future course of FDA's data and technology capabilities 
as FDA transitions to the next phase of its journey. FDA will take an 
iterative approach to strategy development, starting with gathering 
input, then, sharing a draft of the strategic plan for comment and 
finally, considering inputs provided before publishing a final version 
of the strategic plan. FDA will focus on the outcomes to empower the 
Agency to meet its mission, building on the existing FDA Modernization 
Framework and integrating Agency and center strategies. FDA will engage 
internal and external stakeholders early and often throughout this 
process. FDA plans to incorporate stakeholder input as the Agency 
engages with internal and external stakeholders across the remainder of 
this fiscal year including through two Federal Register notices for 
information and comment (this one and a second one for comment on the 
draft strategy). Stakeholder input is crucial for developing a 
comprehensive plan that best meets the needs and goals of industry and 
the Agency.

II. Requested Information and Comments

    Interested persons are invited to provide detailed comments to ODT 
(see ADDRESSES) on the following aspects of the development of FDA's 
Agency-wide Data and Technology Strategic Plan. To facilitate input, 
FDA has developed a series of questions in this section. The questions 
are not meant to be exhaustive, and FDA is also interested in any other 
pertinent information stakeholders would like to share on this topic. 
This feedback will help inform the Agency's strategy development. FDA 
encourages stakeholders to provide the specific rationale and basis for 
their comments, including any available supporting data and 
information. FDA will publish another notice in the Federal Register 
requesting comments once the Data and Technology Modernization Strategy 
is developed.
    1. What are up to three outcomes the FDA Data and Technology 
Strategic Plan can help you achieve, e.g., speed to market?
    2. What are up to three challenges you are facing while trying to 
achieve these outcomes?
    3. What data and technical capabilities could FDA strengthen to 
help support its public health mission?
    4. What opportunities or risks do you foresee for the FDA Data and 
Technology Strategic Plan?
    5. What changes or trends in your industry could impact the FDA 
Data and Technology Strategic Plan?
    6. How might FDA best communicate and engage stakeholders in 
developing and implementing the strategy?

    Dated: April 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07766 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P

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