[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Notices]
[Pages 50030-50031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0257]


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, Health and Human Services (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 September 16, 2020.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

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.

Food and Drug Administration Rapid Response Surveys

OMB Control Number 0910-0500--Extension

    Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 355) requires that important safety information relating to 
all human prescription drug products be made available to FDA so that 
the Agency can take appropriate action to protect the public health 
when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes 
investigational powers to FDA for enforcement of the FD&C Act. Under 
section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to 
require manufacturers to report medical device-related deaths, serious 
injuries, and malfunctions to FDA; to require user facilities to report 
device-related deaths directly to FDA and to manufacturers; and to 
report serious injuries to the manufacturer. Section 522 of the FD&C 
Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct 
postmarket surveillance of medical devices. Section 705(b) of the FD&C 
Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate 
information regarding medical products or cosmetics in situations 
involving imminent danger to health or gross deception of the consumer. 
Section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the 
Commissioner of Food and Drugs to implement general powers (including 
conducting research) to carry out effectively the mission of FDA.
    These sections of the FD&C Act enable FDA to enhance consumer 
protection from risks associated with medical products usage that are 
not

[[Page 50031]]

foreseen or apparent during the premarket notification and review 
process. FDA's regulations governing application for Agency approval to 
market a new drug (21 CFR part 314) and regulations governing 
biological products (21 CFR part 600) implement these statutory 
provisions. FDA's regulations governing Agency oversight of Foods, 
Cosmetics, Dietary Supplements, and Animal Food and Feed (21 CFR parts 
70 through 199) also implement these statutory provisions. Currently, 
FDA monitors medical product related postmarket adverse events via both 
the mandatory and voluntary MedWatch reporting systems using Forms FDA 
3500 and 3500A (OMB control number 0910-0291), electronic Safety 
Reporting Portal (OMB control number 0910-0645), and the vaccine 
adverse event reporting system.
    FDA is seeking extension of OMB approval to collect vital 
information via a series of rapid response surveys. Participation in 
these surveys will be voluntary. This request covers rapid response 
surveys for community-based healthcare professionals, general type 
medical facilities, specialized medical facilities (those known for 
cardiac surgery, obstetrics/gynecology services, pediatric services, 
etc.), other healthcare professionals, patients, consumers, and risk 
managers working in facilities containing products related to or 
regulated by FDA. FDA will use the information gathered from these 
surveys to quickly obtain vital information about medical product risks 
and interventions to reduce risks so the Agency may take appropriate 
public health or regulatory action including dissemination of this 
information as necessary and appropriate.
    FDA projects six emergency risk related surveys per year with a 
sample of between 50 and 10,000 respondents per survey. FDA also 
projects a response time of 0.5 hours per response. These estimates are 
based on the maximum sample size per questionnaire that FDA may be able 
to obtain by working with healthcare professional organizations. The 
annual number of surveys was determined by the maximum past number of 
surveys per year FDA has conducted under this collection.
    Respondents to this collection of information will be identified 
when additional surveillance data will address a potential public 
health hazard. For example, respondents could include facilities or 
professionals that have the most experience in the use of certain FDA-
regulated products, foods, cosmetics, dietary supplements, animal food 
and feed, drugs, tobacco products, etc. Once FDA identifies the need 
for additional surveillance data to address a potential public health 
hazard, the appropriate respondents will be identified either through 
FDA's lists or through the appropriate professional organizations.
    In the Federal Register of February 5, 2020 (85 FR 6559), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Numbers of
           Activity               Numbers of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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FDA Rapid Response Survey.....          10,000               6          60,000  0.5 (30 minutes)          30,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: August 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17928 Filed 8-14-20; 8:45 am]
BILLING CODE 4164-01-P


