Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs, 64438-64440 [2023-20229]

Download as PDF 64438 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 • Improve Data Visibility and Accessibility: Prioritize which data assets to make widely available first based on value to the mission and the most significant number of stakeholders. • Enable Advanced Data Analytics: Ensure experts can easily combine and analyze information from various internal and external sources to gain comprehensive insights. • Enhance Secure Data Exchange: Improve interoperable and secure data exchange and collaboration across FDA and its public health partners. Goal 5: Adopt AI and Mission-Driven Innovations: Drive exploration and address impacts of emerging technologies and trends, such as AI and virtual reality, on FDA’s IT portfolio and regulatory operations. Proactively identify opportunities and risks to FDA’s mission and inform responsible use of technology. Enhance partnerships with external experts to leverage these technologies and promptly respond to their impact. Objectives • Balance Policy and Technology Value: Develop ethical guidance for technology use while maximizing business value, such as Guidance on AI Strategy. Ensure responsible actions by conducting comprehensive research and analysis to fully understand technological advancements’ potential impacts and implications on society. • Ensure Responsible Use of Innovations: Deploy technological innovations, such as AI/Machine Learning, responsibly with an understanding of regulatory impacts and effective risk response strategies. Establish appropriate guardrails where necessary. • Provide Proactive Thought Leadership: Lead as a partner in creating novel use cases for emerging technologies through a deep understanding of business processes, industry, and technology. Stay at the forefront of technological advancements by harnessing industry expertise and fostering collaboration. • Foster Innovation: Create an environment where innovative approaches are encouraged, identified, shared, and evaluated for use in driving operational efficiency and developing new capabilities. Apply a structured process to manage the innovation lifecycle from ideation to investment to adoption (or project shutdown) to produce usable innovations. Goal 6: Cultivate Talent and Leadership: Mature Agency-wide IT competencies to deepen technology expertise and keep pace with the accelerated rate of change in FDA’s VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 regulated industries and technology. Develop holistic leaders equipped to lead through change and drive FDA’s digital transformation journey forward. Deliver enterprise IT services with an Agency-first mindset. Given the continued competition for talent, proactively build a robust talent pipeline for targeted roles leveraging a combination of recruitment, retention, and talent development strategies. Objectives • Instill OneFDA Mindset: Cultivate an Agency-first approach to IT so that decisions promote and protect the health of the American people first and foremost. • Attract and Retain Talent: Build a diverse talent pipeline through a compelling employee value proposition and total compensation approach, talent acquisition, employee engagement, and talent development strategies. Drive improvements across the employee lifecycle from recruitment to retirement. • Hire and Develop Resilient Leaders: Strengthen leadership competencies required to drive holistic transformational IT initiatives in a dynamic environment successfully. • Develop Skills for the Future of Work: Develop IT skills and competencies required to deliver current and future IT services through upskilling, reskilling, and continuous learning. IV. Electronic Access Persons with access to the internet may obtain an electronic version of the IT Strategy at https:// www.regulations.gov. Dated: September 13, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–20136 Filed 9–18–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–3490] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is Frm 00038 Fmt 4703 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 SUMMARY: PO 00000 announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 ‘‘Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs.’’ DATES: Either electronic or written comments on the collection of information must be submitted by November 20, 2023. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 20, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Sfmt 4703 Submit written/paper submissions as follows: E:\FR\FM\19SEN1.SGM 19SEN1 64439 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices • 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–3490 for ‘‘Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3521), 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 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. Application for Participation in FDA Fellowship and Traineeship Programs OMB Control Number 0910–0780— Extension This information collection supports FDA fellowship and traineeship programs. Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. The information collection involves brief online applications completed by applicants applying to FDA’s Fellowship and Traineeship programs. These voluntary online applications will allow the Agency to easily and efficiently elicit and review information from students and healthcare professionals who are interested in becoming involved in FDA-wide activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with FDA. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of respondents ddrumheller on DSK120RN23PROD with NOTICES1 Activity Number of responses per respondent Total annual responses Average burden per response Total hours Medical Device Fellowship Program ................................... FDA Traineeship Program ................................................... 250 1,000 1 1 250 1,000 1 1 250 1,000 Total .............................................................................. ........................ ........................ ........................ ........................ 1,250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1 64440 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: September 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–20229 Filed 9–18–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–2286] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by October 19, 2023. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0621. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 Voluntary National Retail Food Regulatory Program Standards OMB Control Number 0910–0621— Revision This information collection helps support implementation of FDA’s Voluntary National Retail Food Regulatory Program Standards (the Retail Program Standards). Regulatory Program Standards play a critical role in an integrated food safety system and serve as the foundation for mutual reliance between FDA and other regulatory agencies that work to ensure food safety. The Retail Program Standards define what constitutes a highly effective and responsive program for the regulation of foodservice and retail food establishments. The Retail Program Standards are intended to provide a foundation upon which continuous improvements can be made with the ultimate goal to reduce the occurrence of factors that cause and contribute to foodborne illness. In support of this goal, FDA works cooperatively with our State, local, Territorial, and Tribal partners using a risk-based approach to leverage limited resources. We engage in education and outreach efforts to facilitate collaboration with our partners in food safety. The Retail Program Standards represent an important component of a comprehensive strategic approach to help ensure the safety and security of the food supply at the retail level. Respondents to the information collection are State, local, Territorial, and Tribal governments. The Retail Program Standards were revised most recently in August 2022 and include the following elements: (1) regulatory foundation; (2) trained regulatory staff; (3) inspection program based on Hazard Analysis and Critical Control Point principles; (4) uniform inspection program, (5) foodborne illness and food defense preparedness and response; (6) compliance and enforcement; (7) industry and community relations; (8) program support and resources; and (9) program assessment. These elements are enumerated and discussed on our website at https://www.fda.gov/food/ voluntary-national-retail-foodregulatory-program-standards/ voluntary-national-retail-foodregulatory-program-standards-august2022 along with worksheets and assessments that allow FDA to determine conformance with the Retail Program Standards. State, local, territorial, tribal, and Federal regulatory PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 agencies that participate in the voluntary program are required to report information demonstrating that a program self-assessment, a risk factor study of the regulated industry, and an independent outside audit (verification audit) have been completed. The information also includes Form FDA 3958, ‘‘Voluntary National Retail Food Regulatory Program Standards FDA National Registry Report,’’ which may be completed electronically at https:// www.fda.gov/food/voluntary-nationalretail-food-regulatory-programstandards/voluntary-national-retailfood-regulatory-program-standardsaugust-2022. Finally, we are revising the information collection to include additional Agency resources. We have created a dedicated emailbox at retailfoodprotectionteam@fda.hhs.gov to receive requests for program documentation and have developed the following instruments to support the standardization of food safety inspection officer candidates: • Proposed Form FDA 5017, ‘‘Standardized Retail Food Safety Inspection Officer Waiver of Annual Maintenance Requirement Form,’’ pertains to requests for waivers from maintenance requirements, referenced in section 3–403 of the ‘‘FDA Procedures for Standardization of Retail Food Safety Inspection Officers.’’ FDA uses the information submitted on Form FDA 5017 to determine a food safety inspection officer’s eligibility for restandardization. • Proposed Form FDA 5018, ‘‘Standardized Retail Food Safety Inspection Officer Annual Maintenance Form,’’ provides verification that a food safety inspection officer has met program standardization requirements in accordance with section 3–403 of the ‘‘FDA Procedures for Standardization of Retail Food Safety Inspection Officers.’’ • Proposed Form FDA 5019, ‘‘Standardized Food Safety Inspection Officer Nomination Form,’’ allows FDA to collect qualification information from food safety inspection officer candidates. In the Federal Register of August 30, 2023 (88 FR 42372) FDA published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64438-64440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20229]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3490]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Application for Participation in Food and Drug 
Administration Fellowship and Traineeship Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 ``Application for Participation in Food and 
Drug Administration Fellowship and Traineeship Programs.''

DATES: Either electronic or written comments on the collection of 
information must be submitted by November 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 20, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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:

[[Page 64439]]

     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-3490 for ``Application for Participation in Food and Drug 
Administration Fellowship and Traineeship Programs.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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.

Application for Participation in FDA Fellowship and Traineeship 
Programs

OMB Control Number 0910-0780--Extension

    This information collection supports FDA fellowship and traineeship 
programs. Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 
of Title 5 of the United States Code authorize Federal Agencies to rate 
applicants for Federal jobs. The information collection involves brief 
online applications completed by applicants applying to FDA's 
Fellowship and Traineeship programs. These voluntary online 
applications will allow the Agency to easily and efficiently elicit and 
review information from students and healthcare professionals who are 
interested in becoming involved in FDA-wide activities. The process 
will reduce the time and cost of submitting written documentation to 
the Agency and lessen the likelihood of applications being misrouted 
within the Agency mail system. It will assist the Agency in promoting 
and protecting the public health by encouraging outside persons to 
share their expertise with FDA.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Medical Device Fellowship                    250               1             250               1             250
 Program........................
FDA Traineeship Program.........           1,000               1           1,000               1           1,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 64440]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: September 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20229 Filed 9-18-23; 8:45 am]
BILLING CODE 4164-01-P
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