0569_Supporting Statement_2018

0569_Supporting Statement_2018.pdf

Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program

OMB: 0910-0569

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U.S. Food and Drug Administration
Notification of the Intent to Use an Accredited Person
Under the Accredited Persons Inspection Program
OMB Control No. 0910-0569


1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration (FDA or we)
program discussed below and supporting guidance. The Federal Food, Drug, and Cosmetic
Act, as amended (the act, FD&C Act) authorizes FDA to establish a voluntary third-party
inspection program applicable to manufacturers of class II or class III medical devices who
meet certain eligibility criteria. Under section 510(h) of the act, domestic manufacturers of
class II or class III medical devices are subject to inspection for compliance with Quality
System regulations (21 CFR Part 820) and other applicable requirements at least once every
two years. (See 21 U.S.C. 360(h)). The Inspection by Accredited Persons Program (AP
Program) permits eligible manufacturers to schedule qualified independent third-parties to
perform certain inspections. This is a voluntary program. While all firms remain subject to
inspection by FDA, eligible manufacturers have the option of requesting inspection by an
Accredited Person (AP) under the program.
To participate in the AP program, medical device manufacturers must notify FDA. To assist
respondents in this regard, FDA has developed the guidance document, “Manufacturer's
Notification of the Intent to Use an Accredited Person Under the Accredited Persons
Inspection Program Authorized by Section 228 of the Food and Drug Administration
Amendments Act of 2007.” The guidance provides recommendations and instruction to
respondents regarding information needed by FDA to request inspection under the AP
program. The guidance document is available on our website at:
Specific information collection recommended in the guidance includes the following:
Information that demonstrates that the applicant manufactures, prepares, propagates,
compounds, or processes class II or class III medical devices;
Information that shows that the applicant markets at least one of the devices in the
United States;
Information that demonstrates that the applicant markets or intends to market at least
one of the devices in one or more foreign countries and one or both of the following two
conditions are met:


one of the foreign countries certifies, accredits, or otherwise recognizes the
AP the applicant has selected as a person authorized to conduct inspections of
device establishments, or


a statement that the law of a country where the applicant markets or intends
to market the device recognizes an inspection by the FDA or by the AP;

Information that shows that the applicant’s most recent inspection performed by FDA,
or by an AP under this program, was classified by FDA as either “No Action Indicated
(NAI)” or “Voluntary Action Indicated (VAI)”; and
Notification of intent to use an AP, and identification of the AP the applicant selected.
We therefore request OMB approval for the information collection provisions found in the
referenced guidance and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The AP Program is open to both domestic U.S. device establishments and foreign
establishments that are required to register with FDA under section 510(i) of the act,
provided such establishments otherwise meet the program’s eligibility criteria. Information
submitted to FDA under the information collection is used to determine whether respondents
satisfy the eligibility criteria.
3. Use of Improved Information Technology and Burden Reduction
While notifications to FDA do not require a specific format, respondents must identify the
AP chosen to conduct the inspection. Notifications may be submitted electronically and we
estimate 97% of respondents will do so.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. While we have issued related
guidance entitled, “Inspection by Accredited Persons Under The Medical Device User Fee
and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
Criteria,” (approved under OMB Control No. 0910-0510), this information collection is
limited to burden associated with notifications to FDA under the AP program.
5. Impact on Small Businesses or Other Small Entities
The information collection does not impose undue burden on small entities. Rather, it is
intended to provide specific regulatory options to manufacturers of medical devices. At the
same time, FDA aids small business by providing guidance and information through agency
components including the Division of Industry and Consumer Education (DICE) and the
Device Registration and Listing Branch within the Center for Devices and Radiological


Health. DICE provides workshops, onsite evaluations, and other technical and nonfinancial
assistance to small manufacturers. The workshops make available publications and
educational materials, which include medical device establishment and listing requirements.
DICE also maintains a toll-free “800” telephone number and a website which firms may use
to obtain regulatory compliance information.
6. Consequences of Collecting the Information Less Frequently
The information collection is voluntary at the election of respondents.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in
the Federal Register of November 21, 2017 (82 FR 55379). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gifts shall be provided to respondents under the regulation.
10. Assurance of Confidentiality Provided to Respondents
Information provided under this collection is handled in a manner to comply with the FDA
regulations implementing the Freedom of Information Act, 21 CFR part 20.
11. Justification for Sensitive Questions
The information collection does not include questions of a sensitive nature, such as
questions regarding sexual behavior and attitudes, religious beliefs, and other matters that
are commonly considered private.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Activity/ 21 U.S.C. Section

Notification regarding use
of an accredited person-374(g)

Table 1.--Estimated Annual Reporting Burden
No. of
No. of Responses
per Respondent


Burden per


There are approximately 8,000 foreign and 10,000 domestic manufacturers of medical
devices. Approximately 5,000 of these firms only manufacture class I devices and are,
therefore, not eligible for the AP program. In addition, 40 percent of the domestic firms do
not export devices and therefore are not eligible to participate in the AP program. Further,
10 to 15 percent of the firms are not eligible due to the results of their previous inspection.
We therefore estimates there are 4,000 domestic manufacturers and 4,000 foreign
manufacturers that are eligible for inclusion under the AP program. Based on informal
communications with industry, approximately 10 of these manufacturers may submit a
request to use an AP in any given year.
12b. Annualized Cost Burden Estimate
Costs to Respondents:
Type of Respondent

Total Burden Hours

Regulatory Affairs


Hourly Wage Rate

Total Respondent



For a notification of intent to use an AP for an inspection, the total reporting cost to industry
is estimated at $2,250 per submission. Approximately 15 hours are required to complete a
notification. The average to industry per hour for this type of work is $150. The estimated
submission cost of $2,250 multiplied by 10 submissions per year equals $22,500, which is
the aggregated industry reporting cost.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
Government costs include the time required to review the notifications. Assuming that one
full time equivalent (FTE) position consisting of a combination of scientific and engineering
professional and support staff is allocated to the review and processing of notifications, and
using a fully-loaded cost model*, we calculate a cost of $260,286.


Fully Loaded FTE Cost Model (Domestic) for FY 2016. Technical Memorandum, 2016.


15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments since last OMB approval. We have updated
the estimated number of respondents based on the number of notifications received in recent
years. We have reduced the number of respondents from 20 to 10 which results in a
decrease in annual responses by 10 and a corresponding decrease in annual burden hours by
16. Plans for Tabulation and Publication and Project Time Schedule
No publication of information for statistical use is planned.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking an exemption from display of the effective date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.


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