[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60211-60212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0940]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Rapid Response Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 October 2, 2023.

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 0910-0500. 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, 10 
a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [email protected].

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.

Rapid Response Surveys

OMB Control Number 0910-0500--Extension

    This generic information collection supports research conducted by 
FDA, as authorized under section 1003(d)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 393(d)(2)).
    FDA is requesting extension of OMB approval to conduct rapid 
response surveys (RRS). Through these surveys, FDA seeks to determine 
whether a problem impacts the public health and to quickly obtain vital 
information about risks and interventions. FDA will use the information 
gathered from these surveys to make quick turnaround decisions about 
safety problems or risk management solutions so the Agency may take 
appropriate public health action including dissemination of information 
as necessary. Participation in these surveys is voluntary.
    Respondents may include manufacturers and distributors of 
biologics, drugs, food, animal food and drugs, dietary supplements, 
food additives, cosmetics, medical devices, and tobacco products; 
distributors; sponsors and importers; consumers; healthcare 
professionals; hospitals; specialized medical facilities (e.g., cardiac 
surgery, obstetrics/gynecology services, pediatric services, etc.) and 
other user facilities including nursing homes, ambulatory surgical and 
outpatient diagnostic and treatment facilities when FDA must quickly 
determine whether or not a problem impacts the public health. Once FDA 
understands the need for additional surveillance data to address a 
potential public health hazard, the appropriate respondents will be 
identified for each unique RRS.
    In the Federal Register of April 20, 2023 (88 FR 24423), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment, which was generally 
supportive of FDA's use of RRS. (Comment) The comment suggested that 
FDA ``authorize, develop, and implement a mechanism that provides 
States and the most local level of public health departments immediate 
notification and access to RRS results when the FDA issues a RRS wholly 
or partially in their areas of jurisdiction.'' (Response) FDA already 
has in place mechanisms to share pertinent health information with 
State, local, and tribal authorities. We currently share aggregated 
data (without personally identifiable information) of hospital 
reporting RRS. However, FDA's use of RRS has not recently developed 
data about potential safety problems or risk management solutions that 
would require development of a new mechanism for immediate notification 
and access to RRS results. For example, FDA used a RRS to identify and 
maintain a list of drugs essential for the care and management of 
hospitalized patients with COVID-19, particularly for ventilated 
patients in the intensive care units. FDA used the information to help 
to identify drugs that may be at risk of a regional or national 
shortage, and to help ensure these drugs remain available to meet the 
needs of our nation. FDA also used a RRS to engage stakeholders when 
developing the food safety surveillance sampling assignments. FDA 
shared information with key external stakeholders on the hot pepper and 
cucumber sampling assignments and garnered industry feedback through 
survey questions to ensure that sample collection is done as 
effectively and efficiently as possible. Neither of these surveys 
developed information that would require development of a new mechanism 
for immediate notification and access to RRS results. The latest update 
survey data from FDA can be found here: https://www.fda.gov/science-research/fda-science-forum/fda-covid-19-critical-care-drug-monitoring-survey-portal-ongoing-surveillance-critical-drugs-related. Please also 
note that if you or your hospital stakeholders are experiencing a drug 
shortage and need assistance on how to obtain supply, please refer to 
the information at [email protected]. FDA Drug Shortage Staff 
responds to all reports received on a daily basis.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 60212]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                Number of
                 Activity                      Number of      responses per     Total annual          Average burden per response          Total hours
                                              respondents       respondent       responses
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FDA Rapid Response Surveys................          10,000                1           10,000   0.5 (30 minutes)........................           5,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate that each rapid response survey will take no more than 
30 minutes to complete.
    Based on a review of the information collection since our last 
request, we have adjusted our burden estimate which has resulted in a 
decrease to the currently approved burden. We now estimate one response 
per respondent which results in a decrease in overall burden of 25,000 
hours.

    Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18832 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P