CDER NEW Personal Importation of Rx Drugs SSA PR Dec 2019

UNITED STATES FOOD & DRUG ADMINISTRATION
Federal Food, Drug, and Cosmetic Act Section 804:
Personal Importation of Prescription Drugs
21 CFR part 251
OMB Control No. 0910-NEW
RIN-AI45
SUPPORTING STATEMENT – Part A: Justification

1. Circumstances Making the Collection of Information Necessary
The Food and Drug Administration (FDA, the agency, us or we) is promulgating
regulations pursuant to section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 USC 384) to allow importation of certain prescription drugs from Canada. The
proposed regulations are to be codified at 21 CFR part 251 (21 CFR 251). Under the
proposed rule, FDA would authorize Section 804 Importation Programs (SIPs), which
would be overseen by States or certain other governmental entities (SIP Sponsors), to
import certain prescription drugs from Canada. SIP sponsors must submit a proposal that
includes, among other things, information about the SIP Sponsor and the SIP Sponsor’s
importation plan. In addition, SIP Sponsors must provide FDA with data and information
on the drugs the SIP imports and on the SIP’s cost savings to the American consumer.
Importers would have a number of responsibilities related to submitting a Pre-Import
Request to FDA, screening eligible prescription drugs and arranging for importing,
testing, and relabeling. Manufacturers would provide information needed to authenticate
eligible prescription drugs. Accordingly, we are requesting OMB approval of the
proposed information collection provisions contained in the proposed rule entitled
“Importation of Prescription Drugs,” and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The proposed regulations are intended to enable American consumers to benefit from the
lower prices charged for certain prescription drugs in Canada. The information collection
provisions of the proposed rule are designed to facilitate programs for importation of
products that pose no additional risk to the US public’s health and safety, and will result
in a significant reduction in the cost of covered products to American consumers. The
information collected would be used by FDA to review SIP program proposals and
extension requests, including to assess supply chains. Respondents would include SIP
Sponsors (State, tribal, or territorial governmental entities), Importers (pharmacists or
wholesalers), and manufacturers of eligible prescription drugs.
This information collection would be used by the Private Sector (Importers and
manufacturers); State, Local or Tribal Governments (SIP Sponsors); and the Federal
Government to maintain the integrity of the products to be imported through the supply

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chain, demonstrating them to be safe and effective as required under the FD&C Act and
to protect the public from interruptions of supply or diversion of these safe and effective
prescription products.
3. Use of Improved Information Technology and Burden Reduction
We estimate 100% of the respondents will use electronic means to fulfill the agency’s
requirements or requests. The proposed rule states that a SIP Sponsor that seeks to
implement a SIP to import prescription drugs from Canada must submit a proposal to
FDA in electronic form to FDA’s Electronic Submissions Gateway (ESG) or to an
alternative transmission point identified by the agency. In addition, each importer
approved under a SIP sponsor will submit a pre-import request to FDA identifying
information regarding the importation, relabeling of the Canadian products, and relevant
documentation of information necessary to evaluate whether the imported products meet
FDA requirements for manufacturing quality and safety.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The information collection will not have a significant economic impact on a substantial
number of small entities or pose an undue burden on small entities. Contracts resulting
from the proposed rule are voluntary and will depend on the scope and scale of approved
and implemented SIP Proposals, the details of which are unknown.
Under the Regulatory Flexibility Act, FDA analyzes regulatory options that would
minimize any significant impact on small entities. FDA also assists small businesses in
complying with regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
Respondents will respond to the information collection annually and quarterly. There are
no legal obstacles to reduce the burden.
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
Agency
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of 1995 (PRA),
FDA provided an opportunity for public comment on the information collection

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requirements of the proposed rule that published in the Federal Register of December 23,
2019 (84 FR 70796).
9. Explanation of Any Payment or Gift to Respondents
There is no remuneration associated with the proposed information collection.
10. Assurance of Confidentiality Provided to Respondents
We have consulted with our Privacy Office to identify potential risks associated with
privacy information that may be handled by or on behalf of FDA in administration of this
information collection. Although personally identifiable information (PII) would be
collected, it is not subject to the Privacy Act of 1974 and therefore the particular notice
and other requirements of the Privacy Act do not apply. Specifically, FDA does not use
name or any other personal identifier to routinely retrieve records from the information
collected. We have also minimized the PII to be collected to protect the privacy of the
individuals.
11. Justification for Sensitive Questions
The information collection does not include questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden
Type of Information
Collection Activity/
Respondent
SIP Sponsor
251.3; 251.8; 251.14 - SIP
Proposal Submission
Requirements; 251.18 - Post
Importation Requirements;
251.19 - Reports to FDA
Importer
251.5; 251.12; 251.13;
251.17 - Pre-Import Request
and Importation
Requirements
Manufacturer
251.16 Lab Testing
Requirements
Total

No. of
Respondents

Total
Annual
Responses
10

Average
Burden per
Response
360

Total
Hours

10

No. of
Responses per
Respondent
1

10

1

10

24

240

20

1

20

24

480

3600

4320

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Table 2.--Estimated Annual Recordkeeping Burden
Type of Information
Collection Activity/
Respondent
SIP sponsor
251.8 - Modification or
Extension of Authorized
Importation Programs
Importer
251.14(d) – Supply Chain
Security Requirements;
251.17 - Importation
Requirements; 251.18 Post
Importation Requirements
Manufacturer
251.14(b) - Supply Chain
Security Requirements
Total

No. of
Recordkeepers

No. of
Records per
Recordkeeper
10
1

Total
Annual
Records
10

Avg. Burden
per
Recordkeeping
52

Total
Hours
520

10

1

10

24

240

20

1

20

24

480

1240

Table 3.--Estimated Annual Third-Party Disclosure Burden
Type of Information Collection
Activity/
Respondent

Total
Avg.
No. of
Annual
Burden
Disclosures
Disclosures
per
per
Disclosure
Respondent
1
20
24

No. of
Respondents

Manufacturer
251.14(b) - Supply Chain Security
Requirements

20

Total
Hours

480

12b. Annualized Cost Burden Estimate
SIP Sponsors would face costs to prepare proposals, implement approved SIPs, and produce SIP
reports and records. SIPs may offer cost savings to patients, as well as participating wholesale
drug distributors, pharmacies, hospitals, and third-party payers. U.S. drug manufacturers may
face lost U.S. sales (which transfer to Importers and U.S. consumers) as well as certain
compliance costs if their drugs are imported into the United States from Canada. We lack
sufficient information about the likely size and scope of SIP programs and about the specific
drug products that may become eligible for importation and which SIP eligible products are
produced by U.S. drug manufacturers to estimate the present and annualized values of the costs
of the rule.
13.
Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
We lack sufficient information to estimate potential capital, start-up, operating or maintenance
costs associated with this information collection.

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14.

Annualized Cost to the Federal Government

Costs to the Federal government would be absorbed through existing resource allocations and
therefore we estimate no costs at this time.
15.

Explanation for Program Changes or Adjustments

This is a new data collection.
16.

Plans for Tabulation and Publication and Project Time Schedule

The agency has no plans for publication of information from this information collection.
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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