0748 Pediatric Device Use SSA 2020 REV

UNITED STATES FOOD & DRUG ADMINISTRATION
Submission of Information on Pediatric Uses of Medical Devices
OMB Control No. 0910-0748 - Revision
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports section 515A of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360e-1), as well as associated implementing regulations. Section 515A
requires applicants who submit certain medical device applications to include readily available
information providing a description of any pediatric subpopulations that suffer from the disease
or condition that the device is intended to treat, diagnose, or cure. Applicants are also required to
provide the number of affected pediatric patients. Section 515A applies to requests for a
humanitarian device exemption (HDE) submitted under section 520(m) of the FD&C Act;
premarket approval application (PMA), amendment to a PMA, or supplement to a PMA
submitted under section 515 of the FD&C Act; and any product development protocol (PDP)
submitted under section 515 of the FD&C Act. The Food and Drug Administration (FDA, the
agency, us or we) is required to provide an annual report to Congress with this information
(§ 515A(a)(3) of the FD&C Act). Additionally, within the annual report, FDA must include any
information regarding devices used in pediatric patients outside the approved indication for use
(§ 515A(a)(3)(B) of the FD&C Act).
To assist respondents to the information collection we developed the guidance document entitled
“Providing Information About Pediatric Uses of Medical Devices—Guidance for Industry and
Food and Drug Administration Staff,” which describes how to compile and submit the required
readily available pediatric use information. The guidance explains that submission of
information relating to uses of the device outside the approved or proposed indication if such
uses are described or acknowledged in acceptable sources of readily available information is also
permitted. Information collection associated with the guidance is currently approved under
OMB control number 0910-0762 (Providing Information About Pediatric Uses of Medical
Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act). We are revising this
information collection to consolidate these similar elements.
We therefore request approval for the information collection provisions in section 515A(a) of the
FD&C Act; the implementing regulations in 21 CFR part 814; and the associated guidance, as
discussed in this supporting statement
2. Purpose and Use of the Information Collection
Respondents to the information collection are from the private sector (for-profit businesses).
We use the information submitted to ensure that PMA, PDP, and HDE applications include
readily available information concerning pediatric uses. We also use the information to track the
number of approved devices for which there is a pediatric subpopulation that suffers from the

disease or condition that the device is intended to treat, diagnose, or cure; the number of
approved devices labeled for use in pediatric patients; the number of approved pediatric devices
that were exempted from a review fee pursuant to section 738(a)(2)(B)(v); and the review time
for each such device. Ultimately, we would like to use this data to perform a needs assessment
and determine unmet pediatric needs in medical device development. Once unmet needs are
identified, we will be better able to coordinate efforts of stakeholders, device manufacturers and
FDA staff to promote new device development and proper labeling of existing medical devices
for pediatric use.
Additionally, section 515A(a)(3) of the FD&C Act requires FDA the Secretary of Health and
Human Services to submit to the Committee on Health, Education, Labor and Pensions of the
Senate and the Committee on Energy and Commerce of the House of Representatives an annual
report that includes, among other information, the number of devices approved in the year
preceding the year in which the report is submitted, for which there is a pediatric subpopulation
that suffers from the disease or condition that the device is intended to treat, diagnose, or cure.
FDA will use the 515A pediatric device use information included in regulatory submissions to
identify devices that should be included in this annual report to Congress.
3. Use of Improved Information Technology and Burden Reduction
In accordance with statutory requirements as well as current standard industry practice,
submissions are made electronically and therefore we estimate that 100% of submissions will be
made in this way.
4. Efforts to Identify Duplication and Use of Similar Information
Currently we maintain related information collection requests under OMB control number 09100231 (Premarket Approval of Medical Devices and Product Development Protocols) and 09100332 (Humanitarian Device Exemptions) – both supporting regulations in part 814 (21 CFR
814). We will evaluate these collections and make appropriate consolidations prior to a
subsequent renewal request.
5. Impact on Small Businesses or Other Small Entities
Although we estimate few respondents are small businesses, we believe no undue burden is
imposed as a result of the information collection. Additionally, our
Center for Devices and Radiological Health (CDRH), Division of Industry and Consumer
Education (DICE) provides technical and non-technical assistance to small firms (and firms of
any size) expressly to aid them in complying with regulatory requirements of the FD&C Act.
We also aids small business in dealing with the requirements of the regulations by providing
guidance and information through the DICE (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice), through the scientific and administrative staff, and through the CDRH website at
http://www.fda.gov/cdrh.
6. Consequences of Collecting the Information Less Frequently

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Information collection schedule is consistent with statutory and regulatory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances relating to the guidelines of 5 CFR 1320.5.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of December 2, 2019 (84 FR 65986). One comment was received asking the
effect of listed products on children and was therefore beyond the scope of the information
collection topics for which public comment was solicited.
9. Explanation of Any Payment or Gift to Respondents
There is no payment or gift provided to respondents of this information collection.
10. Assurance of Confidentiality Provided to Respondents
In consultation with our Privacy Office we have determined that, although personally identifiable
information (PII) is collected, the collection is not subject to the Privacy Act of 1974 and the
particular notice and other requirements of the Act do not apply. PII is collected in the context
of the subject individuals’ professional capacity and the FDA-related work they perform for their
employer (e.g. point of contact). The PII submitted is name, address, email address, telephone
number. Additionally, we do not use name or any other personal identifier to routinely retrieve
records from the information collected.
Confidentiality of data and disclosure regarding the existence of a PMA are governed by 21 CFR
814.9, the Freedom of Information Act (FOIA) (5 U.S.C. 552), and sections 301(j) and 520(c)
and (h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 331(j), 360(c) and
(h)). Under FOIA, the public has broad access to government documents. However, FOIA
provides certain exemptions from mandatory public disclosure of government records (5 U.S.C.
552(b) (1-9). One such provision, 5 U.S.C. 552(b)(4), exempts “trade secrets and commercial or
financial information that is privileged or confidential” from the requirement of public
disclosure.
Section 520(c) of the Act prohibits FDA from disclosing any information exempted from public
disclosure under 5 U.S.C. 552(b)(4). 21 CFR Part 20, sets forth FDA’s general policy
concerning public availability of FDA records. Under section 520(h) of the Act, FDA is required
to make publicly available a detailed summary of the safety and effectiveness information
contained in a PMA that is the basis for an order approving, denying approval of, or withdrawing
approval of a PMA.
11. Justification for Sensitive Questions

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The information required does not include questions about sexual behavior, attitude, religious
beliefs, or any other matters that are commonly considered private or sensitive in nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Table 1.—Estimated Annual Reporting Burden1
Activity/21 CFR Section or
Guidance

Pediatric information in an
original PMA or PDP-814.20(b)(13)
Pediatric information in a PMA
amendment--814.37(b)(2)
Pediatric information in a PMA
supplement--814.39(c)(2)
Pediatric information in an
HDE--814.104(b)(6)
Pediatric information for uses
outside approved indication—
guidance “Providing
Information About Pediatric
Uses of Medical Devices”
Total

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

11

1

11

8

88

5

1

5

8

40

928

1

928

2

1,856

1

1

1

8

8

800

1

800

.5

400

2,392

We expect to receive approximately 31 original PMA/PDP/HDE applications each year, 1 of
which we expect to be an HDE. This estimate is based on the average number of submissions
received. We estimate that 5 of the 31 original PMA submissions will require amendments to
provide the required pediatric use information. We also expect to receive 928 supplements that
will include the pediatric use information required by 515A(a) of the FD&C Act, and 800 uses
outside approved indication.
We assume 8 hours will be necessary for gathering, organizing, and submitting information that
is readily available, using any approach that meets the requirements of section 515A(a) of the
FD&C Act. Because supplements and information for uses outside approved indications may
incorporate by reference readily-available information on pediatric populations if submitted in a
prior submission, we assume an average time to obtain and submit the information required in a
supplement to be 2 hours and for outside uses to be 30 minutes.
Our estimate of the “Average Burden per Response” is based on our experience and consultation
with similar information collection requirements and on consultations with the Interagency
Pediatric Devices Working Group which includes the Agency for Healthcare Research and
Quality; the FDA, and the National Institutes of Health, members of the Pediatric Advisory

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Committee, researchers, healthcare practitioners, Medical Device Trade Associations, and
Medical Device Manufacturers.
12b. Annualized Cost Burden Estimate
The information collection is expected to be performed by compliance officers, who
perform a literature search of relevant pediatric information, organize any readily available
information, and submit it to FDA. We believe the annual cost burden to the respondents for this
information collection will be $94,125 annually. ($39.35 x 2,392 = $66,528). The hourly wage
rate for a compliance officer was taken from the U.S. Bureau of Labor Statistics, 2018 National
Industry-Specific Occupational Employment and Wage Estimates, SOC 13-1041
(https://www.bls.gov/oes/current/naics4_339100.htm).
Type of Respondent

Total Burden Hourly Wage Rate
Hours

Compliance Officer

2,392

$39.20

Total
Respondent
Costs
$94,125

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs or operating/maintenance costs associated with this regulation.
14. Annualized Cost to the Federal Government
Based on a GS-13 level government employee review of the information submitted, the
annualized cost to FDA is $25,026. This figure was derived by multiplying an average hourly
rate of a GS-13 ($57.40 per hour, https://www.opm.gov/policy-data-oversight/pay-leave/salarieswages/salary-tables/16Tables/html/DCB_h.aspx) by the amount of time it would take to review
pediatric information in the 1,745 submissions (436 hours (rounded) at 15 minutes per
submission).
15. Explanation for Program Changes or Adjustments
The information collection reflects changes and adjustments. We have consolidated burden from
0910-0762, and adjusted individual elements to reflect current data values. This results in an
additional 1,000 responses and 632 hours annually to this information collection, and we will
discontinue control number 0910-0762 upon approval of our request.

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16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish the collection of information under these regulations for statistical
use unless requested by Congress in accordance with Section 533 of the Act.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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