0482 Export Notifications and Records SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Export Notification and
Recordkeeping Requirements (21 CFR 1.101)
OMB Control Number 0910-0482
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations pertaining to notifications and records required for human drug, biological product,
device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of
the Federal Food, Drug, and Cosmetic Act or (FFDCA or the act) (21 U.S.C. 381 and 382), or
section 351 of the Public Health Service Act (PHS) (42 U.S.C. 262). The notification and
recordkeeping is codified at 21 CFR 1.101. As set forth in the regulations, exporters must keep
records demonstrating that exported products:
(1)
(2)
(3)
(4)

meet with the foreign purchaser’s specifications;
do not conflict with the laws of the foreign country;
are labeled on the outside of the shipping package that it is intended for export; and
are not sold or offered for sale in the United States.

Although tobacco products are not currently subject to notification requirements, recordkeeping
elements are applicable to all FDA-regulated products and are enumerated in the regulations. In
accordance with the requirements, records shall be made available to FDA upon request during
an inspection for review and copying.
We therefore request extension of OMB approval for the information collection provisions found
in 21 CFR 1.101, as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
We use the information collection to determine compliance with export requirements prescribed
in the FFDCA and the Public Health Service (PHS) Act. The information collection also allows
us to comply with notification requirements to foreign health officials pertaining to product
exports should we become aware of imminent hazards or other violations specified in the act.
Description of Respondents: Respondents to the collection of information include
manufacturers, distributors, and other persons from the private sector in business and other forprofit institutions who export FDA-regulated products not intended for sale in the United States.

3. Use of Improved Information Technology and Burden Reduction
The collection of information neither requires nor prohibits the use of automated, electronic,
mechanical, or other technological collection techniques. Respondents may submit their
notifications electronically or on paper. While we do not mandate the use of technology to
create or maintain records, it does encourage the use of technology such as office suite computer
software to create and maintain these records. We estimate 90% of the respondents and
recordkeepers for this collection of information will use current technology to submit reports and
create and maintain their records.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Under the FDA Export Reform and
Enhancement Act, FDA is solely responsible for the export of unapproved or otherwise violative
drugs, devices, food and color additives, cosmetics, dietary supplements, blood and blood
products, tissues, and tobacco products. Upon review of our ICR inventory, however, we intend
to consolidate burden associated with Form FDA 766 entitled, “Application for Authorization to
Relabel or to Perform Other Action of the Federal Food, Drug, And Cosmetic Act And Other
Related Acts,” (currently approved under OMB Control No. 0910-0025) into the instant ICR.
Although Form FDA 766 supports requests to relabel and/or recondition all FDA-regulated
articles and applies to import activities, the regulation is related to others covered in subpart E of
our General Enforcement Regulations and we believe, therefore, its burden is more appropriately
accounted for in this collection. The remaining regulations found in subpart E pertain to conduct
during official FDA administrative actions and are therefore excluded from review under the
PRA pursuant to 5 CFR 1320.4(a)(2).
5. Impact on Small Businesses or Other Small Entities
Respondents to this collection of information may include small businesses. However, all
exporters are expected to create reports and maintain records demonstrating that their exported
products meet with the foreign purchaser’s specifications; do not conflict with the laws of the
foreign country; are labeled on the outside of the shipping package that is intended for export;
and are not sold or offered for sale in the United States. We do not believe these requirements
impose undue burden on small entities. At the same time, we provide assistance and resources to
small businesses in complying with FDA regulatory requirements, available from our website at
www.fda.gov.
6. Consequences of Collecting the Information Less Frequently
Respondents to this collection of information will respond by submitting reports or creating and
maintaining records on an occasional basis. Failure to maintain records would impair a firm’s
ability to demonstrate, and our ability to determine, whether exportation of a particular regulated
product complies with statutory requirements. For exports under Section 802 of the act, failure
to maintain records would also be contrary to law.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information. The recordkeeping and
reporting requirements are consistent with the guidelines in 5 CFR 1320.5. The regulation does
not require notifications to occur more frequently than the quarterly basis described in
1320.5(d)(2)(i) nor does it require multiple copies of the notification.
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 inviting public comment on
the information collection in the Federal Register of February 15, 2019 (84 FR 4473). No
comments were received.
9. Explanation of Any Payment or Gift to Respondents
No gifts or payments are provided to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
This ICR is not collecting personally identifiable information (PII) or other data of a personal
nature. Rather, the information collection pertains to the exportation of unapproved new drugs,
biologics, devices, animal drugs, food, cosmetics, and tobacco products. In consultation with our
Privacy Office, we have therefore concluded that a Privacy Act Statement is not applicable to the
information collection. At the same time, information collected is subject to the safeguards
under the Freedom of Information Act and FDA’s related regulations at 21 CFR Part 20.
11. Justification for Sensitive Questions
No questions of a sensitive nature are included in the information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate a total of 22,800 annual burden hours for reporting and a total of 46,530
annual burden hours for recordkeeping, as reflected in Tables 1 and 2, respectively, below.
Table 1.—Estimated Annual Reporting Burden1
21 CFR Section
1.101(d) (CBER)
1.101(d) (CDER)
1.101(d) (CDRH)
TOTAL
1.

Number of
Respondents
5
5
160

Number of
Responses per
Respondent
92
180
1

Total
Annual
Responses
460
900
160
1,520

Average
Burden per
Response
15
15
15

There are no capital or operating and maintenance costs associated with the information collection.

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Total
hours
6,900
13,500
2,400
22,800

The estimated burden figures are based on our experience with the information collection, along
with informal communication with other Federal agencies and industry sources. As a result, we
reduced the estimated number of notifications attributable to CBER by 505 responses and 7,575
hours, which corresponds with a reduction in notifications received over the past few years.
Also, upon a reevaluation of available data, we adjusted estimates associated with CDRH
notifications resulting in a reduction of 8,030 responses and 120,450 hours, finding that our
previous figures had been over-estimated.
Table 2.—Estimated Annual Recordkeeping Burden1
21 CFR Section

No. of
Recordkeepers

1.101 (b), (c), (e) (CBER,
CDER, CDRH, CFSAN,
and CVM)
1.101(b) Office of
International Programs
only
1.101(b) (currently
regulated Tobacco
Products)
TOTAL
1.

No. of
Records per
Recordkeeper

Total
Annual
Records

320

3

960

Average
Burden per
Recordkeeping
(in hours)
22

1

189

189

22

4,158

322

3

966

22

21,252

2,115

Total
Hours
21,120

46,530

There are no capital or operating and maintenance costs associated with the information collection.

Similarly, these figures are based on our experience with the information collection. Our
estimate of burden associated with CTP recordkeeping reflects a reduction of 69 responses and
1,518 burden hours. This adjustment is based on reporting summaries by the Alcohol and
Tobacco Tax and Trade Bureau.
12b. Annualized Cost Burden Estimate
Assuming a cost of $100 per report and multiplying this figure by the total number of
annual records (1,520), we estimate $152,000 in annual reporting costs to exporters of nontobacco products. Similarly, assuming a cost of $100 per record and multiplying this figure by
the number of non-tobacco records (1,149) and tobacco records (966), we estimate $114,900 and
$96,600 in annual recordkeeping costs, respectively. Cumulatively, the total estimated cost is
$363,500.
Table 3 – Estimated Annual Burden Cost
Type of Respondent

Total No. of
Reports/Records

Cost Per
Total Annual
Report/Record Respondent Cost
1,520
$100
$152,000
1,149
$100
$114,900

Non-tobacco export reports
Non-tobacco export
recordkeeping
Tobacco export recordkeeping
TOTAL

966

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$100

$96,600
$363,500

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no total capital or start-up, or operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
To calculate costs to the Federal Government, we multiplied the total number of reports and
records (3,635) by an average hourly wage rate for a full-time Federal employee (GS-13/1) in the
Washington Metropolitan Area, using OPM pay schedules for 2019 ($46.46).
(https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salarytables/19Tables/html/DCB_h.aspx) This results in a total of $168,882 (rounded to the nearest
whole dollar) ($46.46 x 3,635 = $168,882.10).
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments in our estimated burden. Cumulatively these
adjustments result in an overall reduction to the information collection by 8,604 annual responses
and 129,543 burden hours. The majority of this reduction results from correcting previous overestimating associated with CDRH export notifications, however we discuss this more fully at
Question 12 in conjunction with our burden tables. Also, as discussed in more detail in Question
4, we intend to modify the collection to incorporate submissions via Form FDA 766. Currently,
burden for the form is accounted for under OMB Control No. 0910-0025, however we believe
this is an inadvertent oversight. Upon our extension/renewal of OMB Control No. 0910-0025
(expiring July 31, 2020) we will give notice and invite public comment regarding our proposal to
include the form as part of the instant information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no such plans for the information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display the OMB expiration date as required by 5 CFR 1320.5 is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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