Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation; Withdrawal, 36283-36284 [2021-14637]

Download as PDF Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices product information, particularly for applications that include multiple products. All information is entered using electronic Forms FDA 3613d, 3613e, and 3613k and used to evaluate certificate requests. The eCATS Module is Form FDA 3613k, where Form FDA 3613e is the Certificate of Free Sale (https://www.fda.gov/food/food-exportcertificates/online-applications-exportcertificates-food). All ‘‘forms’’ are electronic and part of the eCATS or CAP portal accessed via https:// www.access.fda.gov. To view representations of the forms, you have to download the instructions, which are accessible from the following links: https://www.fda.gov/cosmetics/ cosmetics-exporters/onlineapplications-export-certificatescosmetics and https://www.fda.gov/ food/food-export-certificates/onlineapplications-export-certificates-food. While burden associated with information collection activities for export certificates issued for other FDAregulated products is approved under OMB control number 0910–0498, this collection specifically supports export certificates issued by CFSAN. Also, because we have eliminated paperbased forms, respondents who require assistance with completing export certificate applications online may contact CFSAN directly by email (CFSANExportCertification@ fda.hhs.gov) or telephone (240–402– 2307). Instructions for requesting export certificates for cosmetics (Form FDA 3613d) are available online at https:// www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-cosmetics and instructions for requesting export certificates for food (Forms FDA 3613e and 3613k) are available online at https://www.fda.gov/ food/food-export-certificates/onlineapplications-export-certificates-food. Description of Respondents: The respondents to this collection of information are firms interested in 36283 exporting U.S.-manufactured human food and cosmetic products to foreign countries that require export certificates. In the Federal Register of March 16, 2021 (86 FR 14452), we published a 60day notice requesting public comment on the proposed collection of information. We received one comment offering general support for our cosmetic export certificate program. The comment also recommended FDA consider providing certificates that allow exporters to use an exemption from requirements in China for animal testing for certain imported cosmetic products. We appreciate the comment and continue to seek ways to increase the utility of the information collection as our limited resources permit. At the same time, the comment did not suggest we revise the burden we attribute to the associated information collection activity. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent Total annual responses Average burden per response (in hours) Type of respondent Form No. 2 Cosmetics ..................... Food ............................. FDA 3613d .................. FDA 3613e, 3613k ...... 113 468 3 9 339 4,212 0.5 (30 minutes) .......... 0.5 (30 minutes) .......... 170 2,106 Total ...................... ..................................... ........................ ........................ ........................ ..................................... 2,276 Total hours 1 There 2 All are no capital costs or operating and maintenance costs associated with this collection of information. forms are submitted electronically via FDA Industry Systems. Based on a review of the information collection since our last OMB approval, we have reduced our burden estimate. The burden estimate has been lowered due to a reduced number of respondents. We base our estimates on our experience with certificate applications received in the past 3 fiscal years. Dated: July 2, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14650 Filed 7–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–Z–0025] Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation; Withdrawal Food and Drug Administration (FDA), Department of Health and Human Services (HHS). ACTION: Notice; withdrawal. AGENCY: The Department of Health and Human Services (Department or HHS) is announcing the withdrawal of a notice published in the Federal Register on January 21, 2021, entitled ‘‘Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.’’ HHS also withdraws the requests for proposals issued on its website on September 24, 2020, and revised on January 13, 2021, and ends the period for submission of proposals jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:01 Jul 08, 2021 Jkt 253001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 in response to the requests for proposals. DATES: The notice published in the Federal Register on January 21, 2021, at 86 FR 6343, is withdrawn as of July 9, 2021. FOR FURTHER INFORMATION CONTACT: Katelyn Mineo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993, 301–796– 1054. SUPPLEMENTARY INFORMATION: On September 24, 2020, HHS issued two requests for proposals for the reimportation of insulin and the personal importation of prescription drugs (collectively, the RFPs) and posted related ‘‘Frequently Asked Questions’’ documents (FAQs) on its website. On January 21, 2021, HHS published a notice in the Federal Register entitled ‘‘Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation’’ (the HHS Notice) (86 FR 6343). The HHS Notice referred to revised versions E:\FR\FM\09JYN1.SGM 09JYN1 36284 Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices of the RFPs. The responses to the RFPs were directed in the HHS Notice and in the RFP for Personal Prescription Drug Importation issued on September 24, 2020, and revised on January 13, 2021, to be submitted to an HHS email address: import@hhs.gov, while the RFP for Insulin Reimportation Programs issued on September 24, 2020, and revised on January 13, 2021, directed that responses be sent to import@ hhs.gov and to the Director of the FDA Import Division in the region of the intended port of entry. The Department is not aware that any proposals were received in response to the HHS Notice or RFPs. The HHS Notice, RFPs, and FAQs are withdrawn. All website statements and other informal issuances with respect to the HHS Notice and RFPs are also withdrawn. Accordingly, no proposals submitted to HHS or FDA in response to the HHS Notice or RFPs on or after July 9, 2021 will be considered by HHS or FDA. HHS intends to consider alternatives to the RFPs. Dated: June 11, 2021. Janet Woodcock, Acting Commissioner of Food and Drugs. Dated: June 28, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2021–14637 Filed 7–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 August 9, 2021. 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 0910–0721. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, 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. SUMMARY: Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives Food and Drug Administration [Docket No. FDA–2009–N–0025] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives Food and Drug Administration, Health and Human Services (HHS). AGENCY: ACTION: OMB Control Number 0910–0721— Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue regulations concerning animal food. Specifically, section 403(i) of the FD&C Act (21 U.S.C. 343(i)) requires that certified color additives used in or on a food must be declared by their common or usual names and not be designated by the collective term ‘‘colorings.’’ Our regulations in part 501 (21 CFR part 501) set forth the requirements for animal food labeling. Under § 501.22(k)(21 CFR 501.22(k)), animal food manufacturers must declare on the animal food label the presence of certified and noncertified color additives in their animal food products. Our animal food labeling regulation at § 501.22(k) is consistent with the regulations requiring the declaration of color additives on human food labels. The purpose of the labeling is to provide animal owners with information on the color additives used in animal food. Animal owners use the information to become knowledgeable about the foods they purchase for their animals. Color additive information enables a consumer to comparison shop and to avoid substances to which their animals may be sensitive. In the Federal Register of March 4, 2021 (86 FR 12690), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received 22 comments expressing the importance of color additive information on pet food labeling, along with other ingredient disclosures. FDA appreciates these comments; at this time, we are not revising the regulations found at § 501.22(k) related to color additive information on the labeling of animal food. FDA estimates the burden of this collection of information as follows: Description of Respondents: Respondents to this collection of information are manufacturers of pet food products that contain color additives. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents jbell on DSKJLSW7X2PROD with NOTICES 21 CFR section; activity 501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification. 1 There Number of disclosures per respondent 3,120 0.8292 Total annual disclosures 2,587 Average burden per disclosure 0.25 (15 minutes) ...... are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 17:01 Jul 08, 2021 Jkt 253001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM 09JYN1 Total hours 647

Agencies

[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36283-36284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]


Requests for Proposals for Insulin Reimportation and Personal 
Prescription Drug Importation; Withdrawal

AGENCY: Food and Drug Administration (FDA), Department of Health and 
Human Services (HHS).

ACTION: Notice; withdrawal.

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SUMMARY: The Department of Health and Human Services (Department or 
HHS) is announcing the withdrawal of a notice published in the Federal 
Register on January 21, 2021, entitled ``Requests for Proposals for 
Insulin Reimportation and Personal Prescription Drug Importation.'' HHS 
also withdraws the requests for proposals issued on its website on 
September 24, 2020, and revised on January 13, 2021, and ends the 
period for submission of proposals in response to the requests for 
proposals.

DATES: The notice published in the Federal Register on January 21, 
2021, at 86 FR 6343, is withdrawn as of July 9, 2021.

FOR FURTHER INFORMATION CONTACT: Katelyn Mineo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993, 301-796-
1054.

SUPPLEMENTARY INFORMATION: On September 24, 2020, HHS issued two 
requests for proposals for the reimportation of insulin and the 
personal importation of prescription drugs (collectively, the RFPs) and 
posted related ``Frequently Asked Questions'' documents (FAQs) on its 
website. On January 21, 2021, HHS published a notice in the Federal 
Register entitled ``Requests for Proposals for Insulin Reimportation 
and Personal Prescription Drug Importation'' (the HHS Notice) (86 FR 
6343). The HHS Notice referred to revised versions

[[Page 36284]]

of the RFPs. The responses to the RFPs were directed in the HHS Notice 
and in the RFP for Personal Prescription Drug Importation issued on 
September 24, 2020, and revised on January 13, 2021, to be submitted to 
an HHS email address: [email protected], while the RFP for Insulin 
Reimportation Programs issued on September 24, 2020, and revised on 
January 13, 2021, directed that responses be sent to [email protected] and 
to the Director of the FDA Import Division in the region of the 
intended port of entry. The Department is not aware that any proposals 
were received in response to the HHS Notice or RFPs. The HHS Notice, 
RFPs, and FAQs are withdrawn. All website statements and other informal 
issuances with respect to the HHS Notice and RFPs are also withdrawn. 
Accordingly, no proposals submitted to HHS or FDA in response to the 
HHS Notice or RFPs on or after July 9, 2021 will be considered by HHS 
or FDA. HHS intends to consider alternatives to the RFPs.

    Dated: June 11, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.

    Dated: June 28, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-14637 Filed 7-8-21; 8:45 am]
BILLING CODE 4164-01-P