[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6559-6561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the use of rapid response surveys to obtain 
data on safety information to support quick turnaround decision making 
about potential safety problems or risk management solutions from 
healthcare professionals, hospitals, and other user facilities (i.e., 
nursing homes, etc.); consumers; manufacturers of biologics, drugs, 
food, dietary supplements, cosmetics, animal food and feed, and medical 
devices; distributors; and importers, when FDA must quickly determine 
whether or not a problem with a biologic, drug, food, cosmetic, dietary 
supplement, animal food and feed, or medical device impacts the public 
health.

DATES: Submit either electronic or written comments on the collection 
of information by April 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 
else's 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.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and

[[Page 6560]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-0257 for ``Agency Information Collection Actitivites; 
Proposed Collection; Comment Request; Food and Drug Administration 
Rapid Response Surveys.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential 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 FDA's 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-2015-09-18/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.

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: Under the PRA (44 U.S.C. 3501-3521), 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. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each 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 FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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.

FDA 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 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

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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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     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 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: January 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02240 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P


