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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 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 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 FDAs 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, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA 44 U.S.C. 35013521, Federal Agencies must obtain approval from the Office of Management and Budget OMB for each collection of information they conduct or sponsor.
Collection of information is defined in 44 U.S.C. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each
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proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB
for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3 ways to enhance the quality, utility, and clarity of the information to be collected; and 4
ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Drug Supply Chain Security Act Implementation OMB Control Number 09100806
Revision This information collection helps to support implementation of section 582
of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C. 360eee1.
Enacted in 2013, the Drug Supply Chain Security Act DSCSA Title II of Pub. L.
11354 amended section 582 of the FD&C Act and outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The DSCSA is intended to enhance FDAs ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
Respondents to the information collection are manufacturers, wholesalers, dispensers, and repackagers, as defined in section 581 of the FD&C Act 21 U.S.C. 360eee, of pharmaceutical drug products.
To assist respondents with statutory requirements set forth in section 582
pertaining to notifications of illegitimate products or products with a high risk of illegitimacy, we developed Form FDA
3911 entitled Drug Notification along with the corresponding instructional document INSTRUCTIONS FOR
COMPLETION OF FORM FDA 3911
DRUG NOTIFICATION. Form FDA
3911 and the instructions are available from, and may be completed using, our website at https www.fda.gov/drugs/

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drug-supply-chain-security-act-dscsa/
drug-notifications-frequently-askedquestions. Form FDA 3911 is intended to facilitate notifications governed by section 582 by providing a uniform format for initial notifications, followup notifications, and requests for the termination of a notification.
Section 582 of the FD&C Act also provides for FDA issuance of guidance documents to facilitate implementation of the DSCSA. To that end, we continue to develop guidance documents to assist respondents with information collection provisions set forth in section 582. The procedural guidance document entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification June 2021; available at: https www.fda.gov/
regulatory-information/search-fdaguidance-documents/drug-supplychain-security-act-implementationidentification-suspect-product-andnotification is intended to assist respondents in identifying suspect products, as defined at section 581, and with terminating notifications of illegitimate product or products with a high risk of illegitimacy. As explained in the guidance document, beginning January 1, 2015, certain trading partners i.e., manufacturers, repackagers, wholesale distributors, or dispensers, upon determining that a product in their possession or control is a suspect product, must quarantine the product while they promptly conduct an investigation to determine whether the product is an illegitimate product, must notify FDA if they determine that the product is illegitimate product, and must notify certain trading partners of the illegitimate product as prescribed by section 582. Manufacturers must also notify FDA and certain immediate trading partners after determining that a product in their possession or control has a high risk of being illegitimate product.
Similarly, we developed the draft guidance document Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act May 2018; available at: https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
waivers-exceptions-and-exemptionsrequirements-section-582-federal-fooddrug-and-cosmetic-act. The draft guidance explains Agency established processes by which: 1 A trading partner may request a waiver from certain requirements in section 582 if it would result in an undue economic hardship or for emergency medical reasons; 2 a manufacturer or repackager may request an exception to
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