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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
labeling a statement provided for in section 403r6 of the FD&C Act. In accordance with these requirements, submissions must include: 1 The name and address of the manufacturer, packer, or distributor of the dietary supplement product; 2 the text of the statement that is being made; 3 the name of the dietary ingredient or supplement that is the subject of the statement; 4 the name of the dietary supplement including the brand name;
and 5 the signature of a responsible individual or the person who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

Our electronic form Form FDA 3955
allows respondents to the information collection to electronically submit notifications to FDA via the Food Applications Regulatory Management FARM system. Firms that prefer to submit a paper notification in a format of their own choosing will still have the option to do so; however, Form FDA
3955 prompts respondents to include certain elements in their structure/
function claim notification SFCN
described in 101.93 in a standard electronic format and helps respondents organize their SFCN to include only the information needed for our review of the claim. Note that the SFCN, whether electronic or paper, is used for all claims made pursuant to section 403r6 of the FD&C Act, including nutrient deficiency claims and general
well-being claims in addition to structure/function claims. The electronic form, and any optional elements prepared as attachments to the form e.g., label, can be submitted in electronic format via FARM.
Submissions of SFCNs will continue to be allowed in paper format. We use this information to evaluate whether statements made for dietary ingredients or dietary supplements are permissible under section 403r6 of the FD&C Act.
Description of Respondents:
Respondents to this collection of information include manufacturers, packers, or distributors of dietary supplements that bear section 403r6
of the FD&C Act statements on their labels or labeling.
We estimate the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1

101.93
1 There
3,690

1

Total annual responses 3,690

Average burden per response 0.75 45 minutes

Total hours 2,768

are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
This estimate is based on our experience with this information collection and the number of notifications received in the past 3 years, which has remained constant.
Dated: November 26, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126172 Filed 12121; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration Solicitation of Nominations for Membership To Serve on the National Advisory Council on Migrant Health Health Resources and Services Administration HRSA, Department of Health and Human Services HHS.
ACTION: Request for nominations.
AGENCY:

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Number of responses per respondent
Number of respondents
21 CFR section
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the National Advisory Council on Migrant Health NACMH or advisory committee. The NACMH advises,
SUMMARY:

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consults with, and makes recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of Migrant Health Centers MHCs and other entities under grants and contracts under the Public Health Service PHS Act. HRSA is seeking nominations to fill seven positions on the NACMH.
DATES: HRSA will receive written nominations for NACMH membership on a continuous basis.
ADDRESSES: Nomination packages must be submitted in hard copy to the Designated Federal Official DFO, NACMH, Strategic Initiatives Division, Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, 16N38B, 5600 Fishers Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: All requests for information regarding NACMH nominations should be sent via email to Esther Paul, DFO, NACMH, HRSA at hrsabphcoppdnacmh@hrsa.gov or 3015944300. The NACMH charter and list of current membership are available on the NACMH website at https bphc.hrsa.gov/quality improvement/strategicpartnerships/
nacmh/index.html.
SUPPLEMENTARY INFORMATION: NACMH
was established and authorized under section 217 of the PHS Act 42 U.S.C.
218 to advise, consult with, and make recommendations to the HHS Secretary
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concerning the organization, operation, selection, and funding of MHCs and other entities under grants and contracts under section 330g of the PHS Act 42
U.S.C. 254bg. The NACMH meets twice each calendar year, or at the discretion of the DFO in consultation with the Chair.
Nominations: HRSA is requesting nominations for voting members to serve as Special Government Employees SGEs on the NACMH to fill seven open positions. Specifically, HRSA is requesting nominations for the following positions: Board Member three nominees, Board Member/Patient three nominees, and Administrator Provider one nominee. The Board Member nominees must be members or members-elect of a governing board of an organization receiving funding under section 330g of the PHS Act. The Board Member/Patient nominees must also be patients of the health centers that they represent. Additionally, Board Member nominees must be familiar with the delivery of primary health care to migratory and seasonal agricultural workers MSAWs and their families.
The Administrator/Provider nominee must be qualified by training and experience in the medical sciences or in the administration of health programs for MSAWs and their families. Another individual or organization may nominate an interested applicant.

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