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Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
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with other statutory and regulatory provisions that pertain to devices.
Therefore, stakeholders are invited to submit comments on timelines necessary for this transition and how FDA can facilitate this transition in a way that does not disrupt the supply of these important medical products or place undue burden on manufacturers or on the healthcare delivery system.
4. User Fee Transitions CDER assesses user fees for certain new drug applications NDAs and products approved under those NDAs under the Prescription Drug User Fee Amendments PDUFA. CDER also assesses user fees for certain abbreviated new drug applications ANDAs and products approved under those ANDAs under the Generic Drug User Fee Amendments GDUFA. The PDUFA
and GDUFA user fee programs both include specific fees assessed annually for certain marketed approved products.
In the case of PDUFA, with certain exceptions or exemptions, annual prescription drug program fees are assessed for each strength of a prescription drug identified in an approved NDA, as of October 1 of each fiscal year FY, provided the product is included in the Prescription Drug Product List the active section of Approved Drug Products with Therapeutic Equivalence Evaluations commonly known as the Orange Book.
In the case of GDUFA, annual GDUFA
program fees are assessed with respect to approved ANDAs, and fee amounts are tiered based on the number of approved ANDAs owned by an entity including its affiliates as of October 1
of each fiscal year. GDUFA also includes an annual facility fee for each facility referenced in an approved ANDA as a producer of an active pharmaceutical ingredient or finished dosage form covered by the ANDA.
FDA does not anticipate that the identification and transitioning of products from drug status to device status pursuant to the Genus decision will be completed before October 1, 2021. Persons assessed an annual fee with respect to a product identified in an approved NDA or ANDA as of that date should pay the assessed FY 2022
fees by the due date to avoid being placed on the arrears list and incurring other penalties associated with failure to pay user fees by the due date. Payors of the annual FY 2022 fee with respect to a product that the payor believes should transition to device status under Genus are encouraged to request refunds of user fees attributable to those products.
FDA anticipates that, for approved
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products that transition from drug status to device status under the process described above, refund requests for PDUFA and GDUFA fees that are received on time under section 736i or 744Bm of the FD&C Act 21 U.S.C.
379hi or 379j42m, respectively, will be granted. This would include requests for refund of the FY 2022
prescription drug program fees assessed under PDUFA, or FY 2022 generic drug applicant program fees assessed under GDUFA that may result in a lower fee tier for an ANDA holder, as well as any GDUFA facility fees for a facility referenced in one or more ANDAs that will transition, if that facility is not also reported in other ANDAs that will not transition. Under PDUFA, to qualify for consideration for a refund, a written request must be submitted to FDA not later than 180 calendar days after the fee is due see section 736i of the FD&C
Act. Under GDUFA, to qualify for a return of a fee, a written request justifying the return must be submitted within 180 calendar days from the date of the fee payment see section 744Bm of the FD&C Act.
More information about PDUFA and GDUFA fees and the submission of refund requests is available on FDAs website at https www.fda.gov/
industry/fda-user-fee-programs/
prescription-drug-user-fee-amendments PDUFA and https www.fda.gov/
industry/fda-user-fee-programs/genericdrug-user-fee-amendments GDUFA.
5. Determining Drug or Device Status FDA intends to establish a process for the orderly and efficient determination of which products currently regulated as drugs must be regulated as devices under Genus. We encourage sponsors of potentially affected products to comment on this notice, await the publication of our future notice identifying products that we have tentatively determined should transition to device status, and, in the meantime, reach out to FDA with time-sensitive questions.
FDA has established the following contact point for all questions concerning the Genus decision and transition activities: Drug_Device_
Transition_Inquiry@fda.hhs.gov.
Dated: August 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2015D0868

Development and Submission of Near Infrared Analytical Procedures;
Guidance for Industry; Availability Food and Drug Administration, Health and Human Services HHS.
ACTION: Notice of availability.
AGENCY:

The Food and Drug Administration FDA or Agency is announcing the availability of a final guidance for industry entitled Development and Submission of Near Infrared Analytical Procedures. This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared NIR-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications NDAs, abbreviated new drug applications ANDAs, and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. This guidance finalizes the draft guidance of the same title issued on March 31, 2015.
DATES: The announcement of the guidance is published in the Federal Register on August 9, 2021.
ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows:
SUMMARY:

Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Comments submitted electronically, including attachments, to https
www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone elses Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https www.regulations.gov.

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