Notice of Closed Meeting, 88082-88083 [2023-27972]

Download as PDF 88082 Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 estimates above, the estimated total labor cost attributable to the Rule is approximately $117,606,597 [($63.99 × 888,803 optometrist hours = $56,874,504) + ($127.62 × 156,848 ophthalmologist hours = $20,016,942) + ($19.78 × 1,000,000 prescribers’ office clerk hours = $19,780,000) + ($19.78 × 1,058,400 sellers’ office clerk hours = $20,935,152) = $117,606,598]. Capital and Other Non-Labor Costs Estimated annual non-labor cost burden: $591,300. Staff believes that the Rule’s disclosure and recordkeeping requirements described above impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already (e.g., prescription pads, patients’ medical charts, facsimile machines and paper, telephones, and recordkeeping facilities such as filing cabinets or other storage) to perform those requirements. The 2020 Rule amendments, however, modified the Rule to require that sellers who use automated verification messages record the calls and preserve the recordings for three years. The Commission does not believe that requiring sellers who use automated messages for verification to record the calls and preserve them will create a substantial burden. The requirement will not require additional labor time, since the calls will be for the same duration as they were previously, but may require capital and other nonlabor costs to record the calls and store them electronically. Based on comments supplied during the Rule modification process, the Commission estimates the cost to record each verification call at five cents apiece.38 Based on survey data, approximately 36% of contact lens purchases are from a source other than the prescriber. Assuming that each of the 45 million contact lens wearers in the U.S. makes on purchase per year, this would mean that approximately 16,200,000 contact lens purchases are made annually from sellers other than the prescribers. And since approximately 73% of sales by non-prescriber sellers require verification, this means that approximately 11,826,000 contact lens purchases would require verification calls, faxes, or emails. The Commission does not possess information as to the percentage of verifications completed by 38 85 FR 50711. It is possible this would be a onetime expense for sellers to invest in recording equipment, as opposed to an annual outlay. But in the absence of information as to how sellers manage such recordings, the Commission will assume, for the purpose of this PRA analysis, that recording expense is a recurring annual cost burden. VerDate Sep<11>2014 18:02 Dec 19, 2023 Jkt 262001 telephone versus fax or email, and thus for purposes of this analysis will assume that all verifications are performed via phone and deliver automated messages that are subject to the call-recording requirement. Based on the aforementioned assumptions, the Commission estimates that the requirement to record automated telephone verification messages will cost sellers, in aggregate, $591,300 (11,826,000 × $.05). Total Costs to the Industry (Including Labor and Non-Labor Costs) Combining the annual labor cost burden with the non-labor cost burden, the total cost burden of the Rule is estimated at $118,197,898 ($117,606,598 + $591,300 = $118,197,898). This burden is not insubstantial, but to put it in perspective, a recent survey estimated the value of the U.S. contact lens market at approximately $9.6 billion (not counting examination revenue).39 Therefore, the total cost burden estimate of $118,197,898, imposed by the Rule, represents a cost of approximately 1.2% of the overall retail revenue generated through the sale of contact lenses. Your comment—including your name and your state—will be placed on the public record of this proceeding. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone’s Social Security number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including in particular competitively sensitive information such as costs, 39 See https://www.globenewswire.com/en/newsrelease/2022/09/05/2509723/0/en/Contact-LensesMarket-Size-Will-Achieve-USD-17-4-Billion-by2030-growing-at-6-9-CAGR-Exclusive-Report-byAcumen-Research-and-Consulting.html. Some estimates already put the U.S. contact lens market as high as $17 billion, see https://www.vision monday.com/business/article/us-optical-retailmarket-estimated-at-765-billion-in-the-visioncouncils-first-comprehensive-market-insightsreport/. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Josephine Liu, Assistant General Counsel for Legal Counsel. [FR Doc. 2023–27877 Filed 12–19–23; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Closed Meeting Pursuant to 5 U.S.C. 1009(d), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended, and the Determination of the Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92–463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)– PAR 20–280, Cooperative Research Agreements Related to the World Trade Center Health Program (U01); RFA–OH– 24–002, Exploratory/Developmental Grants on Lifestyle Medicine Research Related to the World Trade Center Health Program (R21); RFA–OH–24– 003, Exploratory/Developmental Grants Related to the World Trade Center Survivors (R21–No Applications with Responders Accepted); and RFA–OH– 24–004, World Trade Center Health Program Mentored Research Scientist Career Development Award (K01). Dates: March 19–21, 2024. Times: 11 a.m.–6 p.m., EDT. Place: Video-Assisted Meeting. Agenda: To review and evaluate grant applications. For Further Information Contact: Laurel Garrison, M.P.H., Scientific Review Officer, Office of Extramural Programs, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 5555 Ridge Avenue, Cincinnati, Ohio 45213. Telephone: (513) 533–8324; Email: LGarrison@cdc.gov. The Director, Office of Strategic Business Initiatives, Office of the Chief E:\FR\FM\20DEN1.SGM 20DEN1 Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2023–27972 Filed 12–19–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–5020] Notice to Public of Website Location of the Office of the Chief Scientist Proposed Guidance Development List AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post a list of possible topics for future guidance document development or revision by the Office of the Chief Scientist (OCS) during the next year. In addition, FDA has established a docket where interested persons may provide comments that could benefit the OCS guidance program and its engagement with stakeholders, including comments on the priority of topics for guidance. This feedback is critical to the OCS guidance program as we consider feedback from stakeholders along with Agency resources and priorities. SUMMARY: You may submit either electronic or written comments at any time as follows: ADDRESSES: ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:02 Dec 19, 2023 Jkt 262001 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–5020 for ‘‘Notice to Public of Website Location of OCS Proposed Guidance Development Agenda.’’ 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 88083 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: Jennifer Ross, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 301–796–4880 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background FDA welcomes comments on any or all of the topics for guidance documents on the list as explained in § 10.115(f)(5) (21 CFR 10.115(f)(5)). FDA has established Docket No. FDA–2023–N– 5020 where comments on the list, drafts of proposed guidance documents on those or other topics, suggestions for new or different guidances within OCS’s purview, and relative priority of listed guidance documents may be submitted and shared with the public (see ADDRESSES). FDA believes this docket is a valuable tool for receiving information from interested persons. FDA anticipates that feedback from interested persons will allow OCS to better prioritize and more efficiently draft guidances to meet the needs of the Agency and our stakeholders. Consistent with the Good Guidance Practices regulation at § 10.115(f)(4), OCS would appreciate suggestions that OCS revise or withdraw an already existing guidance document within OCS’s purview. We request that the suggestion clearly explain why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. II. Website Location of Guidance List This notice announces the website location of the document that provides E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88082-88083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Notice of Closed Meeting

    Pursuant to 5 U.S.C. 1009(d), notice is hereby given of the 
following meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 
U.S.C., as amended, and the Determination of the Director, Office of 
Strategic Business Initiatives, Office of the Chief Operating Officer, 
CDC, pursuant to Public Law 92-463. The grant applications and the 
discussions could disclose confidential trade secrets or commercial 
property such as patentable material, and personal information 
concerning individuals associated with the grant applications, the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy.
    Name of Committee: Disease, Disability, and Injury Prevention and 
Control Special Emphasis Panel (SEP)-PAR 20-280, Cooperative Research 
Agreements Related to the World Trade Center Health Program (U01); RFA-
OH-24-002, Exploratory/Developmental Grants on Lifestyle Medicine 
Research Related to the World Trade Center Health Program (R21); RFA-
OH-24-003, Exploratory/Developmental Grants Related to the World Trade 
Center Survivors (R21-No Applications with Responders Accepted); and 
RFA-OH-24-004, World Trade Center Health Program Mentored Research 
Scientist Career Development Award (K01).
    Dates: March 19-21, 2024.
    Times: 11 a.m.-6 p.m., EDT.
    Place: Video-Assisted Meeting.
    Agenda: To review and evaluate grant applications.
    For Further Information Contact: Laurel Garrison, M.P.H., 
Scientific Review Officer, Office of Extramural Programs, National 
Institute for Occupational Safety and Health, Centers for Disease 
Control and Prevention, 5555 Ridge Avenue, Cincinnati, Ohio 45213. 
Telephone: (513) 533-8324; Email: [email protected].
    The Director, Office of Strategic Business Initiatives, Office of 
the Chief

[[Page 88083]]

Operating Officer, Centers for Disease Control and Prevention, has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities, 
for both the Centers for Disease Control and Prevention and the Agency 
for Toxic Substances and Disease Registry.

Kalwant Smagh,
Director, Office of Strategic Business Initiatives, Office of the Chief 
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2023-27972 Filed 12-19-23; 8:45 am]
BILLING CODE 4163-18-P

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