Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees, 54324-54326 [2023-17154]

Download as PDF 54324 Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice. DATES: Any small business tobacco manufacturing industry organization interested in participating in the selection of appropriate nonvoting members to represent industry interests must send a letter stating that interest to the FDA by September 11, 2023, (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by September 11, 2023. ADDRESSES: All statements of interest from small business tobacco manufacturing industry organizations interested in participating in the selection process of nonvoting industry representative nominations should be sent to CAPT Serina Hunter-Thomas (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s website https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Office of Science, Center for Tobacco Products, Food and Drug Administration, Center for Tobacco Products Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1–877–287–1373 (choose Option 5), or by email: TPSAC@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency intends to add nonvoting industry representative(s) to the following advisory committee: I. Tobacco Products Scientific Advisory Committee The Tobacco Products Scientific Advisory Committee (the Committee) advises the Commissioner of FDA (the Commissioner) or designee in discharging responsibilities related to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating VerDate Sep<11>2014 17:28 Aug 09, 2023 Jkt 259001 to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner. The Committee includes three nonvoting members who represent industry interests. These members include one representative representing the interests of the tobacco manufacturing industry, one representative representing the interests of tobacco growers, and one representative representing the interests of the small business tobacco manufacturing industry, which may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. With this notice, nominations are sought for the following positions: A pool of individuals, with varying areas of expertise, to represent the interests of the small business tobacco manufacturing industry on a rotating, sequential basis. all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. Food and Drug Administration III. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Dated: August 7, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–17149 Filed 8–9–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2010–N–0583] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) 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 September 11, 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 0910–0053. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of Operations, Food and Drug Administration, Three SUMMARY: E:\FR\FM\10AUN1.SGM 10AUN1 Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 240–994–7399, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Radioactive Drug Research Committees OMB Control Number 0910–0053— Extension This information collection request supports the implementation of statutory and regulatory requirements and associated Agency forms. Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371) establish provisions under which FDA issues regulations governing the use of radioactive drugs for basic scientific research. Specifically, § 361.1 (21 CFR 361.1) sets forth specific regulations about establishing and composing radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies using radiopharmaceuticals, including reporting, recordkeeping, and labeling requirements. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulations and include studies of metabolism, human physiology, pathophysiology, or biochemistry. To assist respondents with the applicable reporting requirements, we developed Form FDA 2914 entitled, ‘‘Report on Research Use of Radioactive Drugs: Membership Summary,’’ available at https://www.fda.gov/media/ 73820/download; and Form FDA 2915, entitled, ‘‘Report on Research Use of Radioactive Drugs: Study Summary,’’ available at https://www.fda.gov/media/ 71805/download. We also developed the guidance document entitled, ‘‘Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application’’ (August 2010), available at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/radioactive-drug-researchcommittee-human-research-withoutinvestigational-new-drug-application, which provides information to help determine whether research studies may be conducted under an FDA-approved RDRC, or whether research studies must be conducted under an investigational new drug application (IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, 54325 functions, and reporting requirements of an RDRC approved by FDA. All Agency guidance documents are issued consistent with our good guidance practice regulations at 21 CFR 10.115. Types of research studies not permitted under the regulations are also specified and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial for safety or efficacy). These studies require filing of an IND under 21 CFR part 312, and the associated information collections, are covered in OMB control number 0910– 0014. The primary purpose of this collection of information is to determine whether the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson or chairpersons of each individual RDRC, investigators, and participants in the studies. In the Federal Register of March 16, 2023 (88 FR 16272), FDA published a 60-day 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: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR section; FDA form or activity Total annual responses Average burden per response Total hours § 361.1(c)(3) reports and (c)(4) approval; Form FDA 2914 (Membership Summary). § 361.1(c)(3) reports; Form FDA 2915 (Study Summary) § 361.1(d)(8); adverse events ............................................ 56 1 56 1 ............................. 56 37 10 10 1 370 10 3 ............................. 0.5 (30 mins) .......... 1,110 5 Total ............................................................................ .......................... .......................... .......................... ................................ 1,171 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers ddrumheller on DSK120RN23PROD with NOTICES1 21 CFR section; and activity Number of records per recordkeepers Total annual records Average burden per recordkeeping Total Hours § 361.1(c)(2); RDRC maintains meeting minutes involving use in human research subjects. § 361.1(d)(5); RDRC obtains consent of human research subjects. 56 10.61 594 4.239 ...................... 2,518 Total ............................................................................ .......................... .......................... .......................... ................................ 2,518 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 17:28 Aug 09, 2023 Jkt 259001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1 54326 Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices The burden attributed to recordkeeping activities is assumed to be distributed among the individual elements and averaged among respondents. In the burden estimate, we assume an average burden per record of 10 hours for the RDRC respondents to maintain meeting minutes and 0.75 hours (45 minutes) for a subset of the respondents (37 RDRCs) to obtain consent of human research subjects. Section 361.1(f) sets forth labeling requirements for radioactive drugs. These requirements are not in the burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)). Our estimated burden for the information collection reflects an overall decrease of 703 hours and a corresponding decrease of 158 responses. We attribute this adjustment to a decrease in the average burden per response, from 3.5 hours to 3 hours per response, associated with the public reporting burden for Form FDA 2915. The decrease is based on our program experience and matches the burden hours reflected on the form. In addition, this adjustment is also attributable to the Agency receiving fewer submissions over the last few years. Dated: August 7, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–17154 Filed 8–9–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0918] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements 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 September 11, 2023. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:28 Aug 09, 2023 Jkt 259001 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 0910–0381. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.–12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Food Labeling Requirements OMB Control Number 0910–0381— Revision This information collection supports statutory and regulatory requirements that govern food labeling, and information collection recommendations discussed in associated Agency guidance. Sections 4, 5, and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e), establish provisions under which a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. Implementing regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105). While regulations in part 101 set forth general food labeling provisions, requirements pertaining to the common or usual name for nonstandardized foods; guidelines for nutritional quality to prescribe the minimum level or range of nutrient composition appropriate for a given class of food; and requirements for foods for special dietary use are found in parts 102, 104, and 105, respectively. The requirements are intended to ensure the safety of food products produced or sold in the United States and enable consumers to be knowledgeable about PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 the foods they purchase and include corresponding information disclosure requirements, along with the reporting and recordkeeping provisions, subject to enforcement by FDA. We provide information resources regarding food labeling under the FD&C Act and its amendments on our website at https://www.fda.gov/food/foodlabeling-nutrition. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary. We refer to these products as ‘‘conventional’’ foods. For detailed information on dietary supplement labeling requirements visit our website at https://www.fda.gov/food/dietarysupplements. Nutrition labeling provides information for use by consumers in selecting a nutritious diet. Other information enables consumers to comparison shop. Ingredient information also enables consumers to avoid substances to which they may be sensitive. Petitions or other requests submitted to us provide the basis for us to permit new labeling statements or to grant exemptions from certain labeling requirements. Recordkeeping requirements enable us to monitor the basis upon which certain label statements are made for food products and whether those statements are in compliance with the requirements of the FD&C Act or the FPLA. Requirements include general content and format for the labeling of food packaging, including nutrition and ingredient information. Additional regulations provide for specific nutrient content claims. The information collection includes Form FDA 3570 entitled, ‘‘Small Business Nutrition Labeling Exemption Notice,’’ for use as applicable and available for download from our website at https://www.fda.gov/food/labelingnutrition-guidance-documentsregulatory-information/small-businessnutrition-labeling-exemption-noticemodel-form. We have also developed the following guidance documents to assist respondents with various aspects of the information collection: • ‘‘Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body’’ (June 1998). The guidance document is available from our website at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industrynotification-health-claim-or-nutrientcontent-claim-based-authoritativestatement. The guidance document E:\FR\FM\10AUN1.SGM 10AUN1

Agencies

[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54324-54326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17154]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0583]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Radioactive Drug 
Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 September 11, 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 0910-0053. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three

[[Page 54325]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 240-994-7399, [email protected].

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.

Radioactive Drug Research Committees

OMB Control Number 0910-0053--Extension

    This information collection request supports the implementation of 
statutory and regulatory requirements and associated Agency forms. 
Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321, 355, and 371) establish provisions under which FDA 
issues regulations governing the use of radioactive drugs for basic 
scientific research. Specifically, Sec.  361.1 (21 CFR 361.1) sets 
forth specific regulations about establishing and composing radioactive 
drug research committees (RDRCs) and their role in approving and 
monitoring basic research studies using radiopharmaceuticals, including 
reporting, recordkeeping, and labeling requirements. No basic research 
study involving any administration of a radioactive drug to research 
subjects is permitted without the authorization of an FDA-approved RDRC 
(Sec.  361.1(d)(7)). The type of research that may be undertaken with a 
radiopharmaceutical drug must be intended to obtain basic information 
and not to carry out a clinical trial for safety or efficacy. The types 
of basic research permitted are specified in the regulations and 
include studies of metabolism, human physiology, pathophysiology, or 
biochemistry.
    To assist respondents with the applicable reporting requirements, 
we developed Form FDA 2914 entitled, ``Report on Research Use of 
Radioactive Drugs: Membership Summary,'' available at https://www.fda.gov/media/73820/download; and Form FDA 2915, entitled, ``Report 
on Research Use of Radioactive Drugs: Study Summary,'' available at 
https://www.fda.gov/media/71805/download.
    We also developed the guidance document entitled, ``Radioactive 
Drug Research Committee: Human Research Without An Investigational New 
Drug Application'' (August 2010), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application, which provides information to help determine whether 
research studies may be conducted under an FDA-approved RDRC, or 
whether research studies must be conducted under an investigational new 
drug application (IND). It also offers answers to frequently asked 
questions on conducting research with radioactive drugs, and provides 
information on the membership, functions, and reporting requirements of 
an RDRC approved by FDA. All Agency guidance documents are issued 
consistent with our good guidance practice regulations at 21 CFR 
10.115.
    Types of research studies not permitted under the regulations are 
also specified and include those intended for immediate therapeutic, 
diagnostic, or similar purposes or to determine the safety or 
effectiveness of the drug in humans for such purposes (i.e., to carry 
out a clinical trial for safety or efficacy). These studies require 
filing of an IND under 21 CFR part 312, and the associated information 
collections, are covered in OMB control number 0910-0014.
    The primary purpose of this collection of information is to 
determine whether the research studies are being conducted in 
accordance with required regulations and that human subject safety is 
assured. If these studies were not reviewed, human subjects could be 
subjected to inappropriate radiation or pharmacologic risks. 
Respondents to this information collection are the chairperson or 
chairpersons of each individual RDRC, investigators, and participants 
in the studies.
    In the Federal Register of March 16, 2023 (88 FR 16272), FDA 
published a 60-day 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
      21 CFR section; FDA form or activity          Number of      responses per     Total annual           Average burden per response           Total
                                                   respondents       respondent       responses                                                   hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   361.1(c)(3) reports and (c)(4) approval;               56                1               56  1..........................................       56
 Form FDA 2914 (Membership Summary).
Sec.   361.1(c)(3) reports; Form FDA 2915                     37               10              370  3..........................................    1,110
 (Study Summary).
Sec.   361.1(d)(8); adverse events.............               10                1               10  0.5 (30 mins)..............................        5
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ...........................................    1,171
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
          21 CFR section; and activity              Number of       records per      Total annual         Average burden per recordkeeping        Total
                                                  recordkeepers    recordkeepers       records                                                    Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   361.1(c)(2); RDRC maintains meeting                    56            10.61              594  4.239......................................    2,518
 minutes involving use in human research
 subjects.
Sec.   361.1(d)(5); RDRC obtains consent of
 human research subjects.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ...........................................    2,518
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 54326]]

    The burden attributed to recordkeeping activities is assumed to be 
distributed among the individual elements and averaged among 
respondents. In the burden estimate, we assume an average burden per 
record of 10 hours for the RDRC respondents to maintain meeting minutes 
and 0.75 hours (45 minutes) for a subset of the respondents (37 RDRCs) 
to obtain consent of human research subjects.
    Section 361.1(f) sets forth labeling requirements for radioactive 
drugs. These requirements are not in the burden estimate because they 
are information supplied by the Federal Government to the recipient for 
the purposes of disclosure to the public (5 CFR 1320.3(c)(2)).
    Our estimated burden for the information collection reflects an 
overall decrease of 703 hours and a corresponding decrease of 158 
responses. We attribute this adjustment to a decrease in the average 
burden per response, from 3.5 hours to 3 hours per response, associated 
with the public reporting burden for Form FDA 2915. The decrease is 
based on our program experience and matches the burden hours reflected 
on the form. In addition, this adjustment is also attributable to the 
Agency receiving fewer submissions over the last few years.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17154 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P


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