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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
assume wholesale distributors will expend 1 hour for each notification.
Because the extent of distribution of any illegitimate product will vary, we assume a wide distribution for each illegitimate product for purposes of establishing our burden estimate. We estimate that, for each notification that a manufacturer or repackager makes to FDA, the manufacturer or repackager will notify approximately 30 trading partners relying on the number of distributors. This formula results in approximately 3,000 notifications annually to trading partners of manufacturers and repackagers. This estimate includes the notifications by manufacturers and repackagers who have determined that an illegitimate product is in their possession or control, as well as notifications by manufacturers who have determined that a product poses a high risk of illegitimacy.
We assume that a large wholesale distributor may have up to 4,500 trading partners, where a small wholesale distributor may have 200 trading partners, averaging approximately 2,350. We had originally estimated that a wholesale distributor would notify all 2,350 trading partners for each of the illegitimate products identified.
However, as a result of our experience with the collection and informal feedback from industry, we have lowered our estimate to reflect that 138
respondents will make 1,175 disclosures for a total of 162,150 disclosures annually and that each disclosure will require approximately 12 minutes, for a total of 32,430 hours annually.
We estimate that a pharmacy purchases prescription drugs from an average of two wholesale distributors.
Therefore, a pharmacy would notify 2
trading partners for each of the 12
illegitimate products identified. This estimate results in in approximately 24
notifications annually to pharmacy trading partners.
We estimate that the burden for notifying trading partners of an illegitimate product and the number of trading partners notified will be the same as the estimates for notification of termination. The estimated total burden hours to notify trading partners that the notification is terminated is approximately 33,035 hours annually.
We assume a comparable amount of time is required to provide the information necessary for requesting to terminate a notification. The time required to investigate and resolve an illegitimate product notification will vary, but we assume that each notification will eventually be terminated. We assume that the number
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of requests for termination of a notification per year will be the same as the original number of notifications for a given year. The estimated total burden hours to make requests for termination of notifications to FDA is 250 hours annually.
Based on communications we have had with trading partners and stakeholders since the 2013 enactment of the DSCSA, we estimate that 20
trading partners or stakeholders will submit approximately 20 requests for a waiver, an exception, or an exemption.
Also based on feedback from industry stakeholders, we estimate that respondents will expend an average of 80 hours to prepare and submit each request and to submit any additional followup information that we may request. We estimate the total burden as approximately 1,600 hours.
We estimate that we will receive from approximately one respondent approximately one notification or other information informing us that there has or has not been a material change in the circumstances that warranted the waiver, exception, or exemption and that each notification will require approximately 16 hours to prepare and submit to us. We estimate the total burden as approximately 16 hours.
We estimate that we will receive approximately one renewal request from approximately one respondent and that each request will require approximately 16 hours to prepare and submit to us.
We estimate the total burden as approximately 16 hours.
Our estimated burden for the information collection reflects an overall increase of 56,116 hours and a corresponding increase of 271,638
responses annually. We attribute this adjustment to an increase in the number of illegitimate product notification submissions we received in the last couple of years and the number of such submissions we have received so far this fiscal year.
Dated: August 25, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119061 Filed 9221; 8:45 am
Food and Drug Administration Docket No. FDA2012N0536

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
and Device Facility User Fee Cover Sheet, Form FDA 3601a AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we 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 October 4, 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 ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100511 Also include the FDA docket number found in brackets in the heading of this document.
SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017968867, PRAStaff@
fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.

SUPPLEMENTARY INFORMATION:

Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a OMB Control Number 09100511
Revision
BILLING CODE 416401P

PO 00000

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of 2002
Pub. L. 107250, and the Medical Device User Fee Amendments of 2007
Title II of the Food and Drug
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