Federal Register - July 9, 2021
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Source: Federal Register
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 09100498, 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 240402
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
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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 1ESTIMATED 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. 202114650 Filed 7821; 8:45 am BILLING CODE 416401P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021Z0025
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
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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, 301796
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
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