[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23048-23050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08763]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1423]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Imports and 
Electronic Import Entries

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by May 26, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0046. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Imports and Electronic Import Entries

OMB Control Number 0910-0046--Revision

    This information collection supports Agency regulations found in 21 
CFR part 1, subparts D (Sec. Sec.  1.70 through 1.81 (21 CFR 1.70 
through 1.81)) and E (Sec. Sec.  1.83 through 1.101 (21 CFR 1.83 
through 1.101)), governing FDA import activities and related Agency 
guidance. Specifically, the regulations prescribe the required data 
elements that respondents must submit when importing, or offering for 
import, an FDA-regulated article into the United States. Review of the 
data elements allows FDA to continue to meet its responsibilities 
pertaining to current submission requirements established by the U.S. 
Customs and Border Protection (CBP) related to the submission of entry 
information in using its Automated Commercial Environment (ACE) system, 
or any CBP-authorized electronic data interchange (EDI) system. 
Respondents (ACE filers) submit important and useful information about 
FDA-regulated products being imported or offered for import into the 
United States so that we may effectively and efficiently review 
products and determine their admissibility. In addition, and as set 
forth in the regulations, certain product types are subject to 
additional data elements (for example, 21 CFR 1.77 prescribes 
additional data elements for radiation-emitting products), as well as 
those data elements applicable to all products.
    We are revising the information collection to provide for a weekly 
entry filing program (WEF). More detailed information on Foreign Trade 
Zones (FTZ)/WEF, is available at https://www.fda.gov/industry/import-basics/foreign-trade-zonesweekly-entry-filing. The WEF program, which 
is available for some FDA-regulated products, allows entry filers to 
file a single entry estimating the amount of merchandise anticipated to 
be removed from an FTZ and offered for U.S. consumption during a 7-day 
period. To participate, we recommend respondents who wish to file a 
weekly entry of FDA-regulated products with CBP to first request a 
preliminary assessment from FDA. As part of this assessment, we 
recommend submission of the following information:
     FDA Import Division(s) \1\ with geographic oversight over 
the FTZ location;
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    \1\ Some FTZs are covered by multiple Import Divisions.
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     Identification of whether products are manufactured or 
stored in the FTZ;
     FTZ site/subzone number and address;
     Importer of Record (IOR) Facility Establishment Identifier 
(FEI), if known;
     Manufacturer FEI, if known; and
     Port of entry.
    The division information is necessary so that we can appropriately 
route the submission within the Agency. Information on whether the 
product is stored or manufactured in the zone is necessary for FDA to 
determine the applicable admissibility requirements. The FTZ and port 
information is necessary to ensure that basic requirements in 19 CFR 
part 146 are met. The IOR and manufacturer FEI information is requested 
by FDA to expedite the admissibility review. Requests to participate in 
the WEF process are submitted to the FDA Import Division Office 
covering the intended port of entry.
    We are also revising the information collection to include our 
Import Trade Auxiliary Communication System (ITACS), currently approved 
under OMB control number 0910-0842. The ITACS is used by the import 
trade community and was implemented to improve communication with FDA. 
By utilizing ITACS, respondents to the information collection have the 
ability to establish an account and electronically check the status of 
FDA-regulated entries and lines, submit entry documentation, submit the 
location of goods availability for those lines targeted for examination 
by FDA, and check the estimated laboratory analysis completion dates 
for lines that have been sampled. For further information regarding 
ITACS, please visit our website at https://www.fda.gov/industry/import-systems/itacs.
    In the Federal Register of January 3, 2020 (85 FR 318), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. Upon review of 
our active information collection inventory, however, and on our own 
initiative, we have decided to make additional revisions to the 
information collection to improve the efficiency of Agency operations. 
Specifically, we are including Form FDA 766 ``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 number 0910-0025) as the collection 
instrument for 21 CFR 1.95. Form FDA 766 facilitates collection of 
information associated with certain general enforcement provisions for 
importing FDA-regulated articles into the United States. The form

[[Page 23049]]

is available on the internet at https://www.fda.gov/industry/actions-enforcement/reconditioning.
    Relatedly, we also are revising the information collection to 
include reference to Agency guidance entitled ``Pre-Launch Activities 
Importation Requests (PLAIR).'' Historically, when applicants with a 
pending new drug application, abbreviated new drug application, or 
Center of Drug Evaluation and Research-regulated biologics licensing 
application (information collection associated with these submissions 
is currently approved under OMB control number 0910-0001) sought to 
import unapproved finished dosage form drug products into the United 
States in preparation for market launch, we considered such requests, 
informally referred to as ``PLAIRs,'' on a case-by-case basis. Since 
implementing the PLAIR program in 2013, interest continues to increase, 
so we continue to develop a more formalized process.
    Accordingly, to facilitate submissions and improve our own 
efficiencies, we published a notice of availability in the Federal 
Register of July 24, 2013 (78 FR 44572), announcing a draft guidance 
document discussing our PLAIR program, including an analysis under the 
PRA of the burden we estimate is attributable to the applicable 
information collection activities. We ultimately intend to finalize the 
guidance document to further clarify our recommendations on what 
products are eligible for a PLAIR, what information should be included 
in a PLAIR submission, when and how a PLAIR can be submitted to FDA, 
and the circumstances under which the Agency intends to grant a PLAIR. 
We therefore are including this estimate to account for burden that may 
be associated with this information collection. The draft guidance is 
available from our website at: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports and is being 
issued consistent with our good guidance practice regulations in 21 CFR 
10.115, which provide for public comment on Agency guidance documents 
at any time.
    Description of Respondents: Respondents to the information 
collection are domestic and foreign importers of FDA-regulated articles 
being imported or offered for import into the United States and entry 
filers who submit import entries on behalf of these importers.
    As a result of these revisions, we have adjusted our burden 
estimate for the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    Number of
                                       Number of    responses      Total       Average burden per
      21 CFR part 1, subpart D        respondents      per         annual           response         Total hours
                                                    respondent   responses
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Importers submission of data               85,480        10.05      859,074  0.05576 hours (3.346         47,902
 elements (preparing the required                                             minutes).
 information).
Entry filers (unique lines only)....        3,419       12,196   41,698,124  0.04466 hours (2.68       1,862,238
                                                                              minutes).
WEF participants....................           15            1           15  0.87 hours (52                13.05
                                                                              minutes).
ITACS; creation of new account......          500            1            1  0.5 (30 minutes)......          250
Form FDA 766........................          324            1          324  0.25 (15 minutes).....           81
Submissions in accordance w/PLAIR...           70            5          350  16....................        5,600
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    Total...........................  ...........  ...........   42,557,888  ......................    1,916,084
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\1\ There are no capital or operational and maintenance costs associated with the information collection.

    As reflected in table 1, rows 1 and 2, we estimate 85,480 importers 
and 3,419 entry filers will make submissions. An importer of record may 
be the owner or purchaser of the article being imported or offered for 
import, or a customs broker licensed by CBP under 19 U.S.C. 1641 who 
has been designated by the owner, purchaser, or consignee to file the 
import entry. There is only one importer of record per entry. We have 
updated the number of responses and respondents since last OMB review 
of the information collection to reflect the best data available to the 
Agency from January 1, 2018, to December 31, 2018. We retain our 
currently approved estimate of the number of responses per respondent 
and time per response as representative of the industry average.
    As reflected in table 1, row 3, we estimate 15 respondents will 
submit WEFs. Persons wishing to file weekly entries of FDA regulated 
products are encouraged to provide the information identified so that 
FDA can conduct a preliminary admissibility assessment of the 
associated products and firms. This submission typically contains the 
information FDA requests for multiple products (i.e., the respondent 
wishes to file weekly entries for multiple products and submits the 
information for each product together). Generally, submissions 
involving multiple products are significantly less burdensome on a per-
product basis. We estimate that the burden for each product in a WEF 
submission is approximately 52.5 minutes, for a total of 13.125 hours 
annually. Depending on the product and scale of submission, this 
estimated burden can fall to as low as 15 minutes per product. The 
reason why this burden can be significantly higher than an ACE 
submission is that the WEF submission is done manually, typically 
through a spreadsheet. Filers submitting in ACE typically use software 
that is developed to specifically automate and expedite the entry 
submission process and allows filers to automatically upload entry 
information. While the WEF submission includes an initial one-time 
submission burden, we expect reduced burden over a long term because 
filers can subsequently submit one entry covering multiple withdrawals 
from the FTZ in any given 7-day period.
    As reflected in table 1, row 4, we estimate that 500 new ITACS 
accounts will be created annually. Since developing and implementing 
ITACS, we believe that most users have already created an account and, 
therefore, we have adjusted this estimate downward since last OMB 
review and approval.
    As reflected in table 1, row 5, we estimate the submission of 324 
Forms FDA 766 in conjunction with FDA-regulated products. This figure 
is based on Agency import data and our experience with the information 
collection. We assume it takes respondents 15 minutes to complete and 
submit Form FDA 766. Although current instructions communicate that 
four copies be submitted (one copy to be returned to respondent), we 
plan to update the form to reduce this number.

[[Page 23050]]

    As reflected in table 1, row 6, we estimate 70 submissions under 
the PLAIR program. Since implementation of PLAIR there has been 
significant interest. We have therefore doubled our original estimate 
of 35 to 70 respondents annually but retain the average burden per 
response of 16 hours to provide the information recommended in the 
draft guidance.
    Cumulatively these changes and adjustments result in a reduction in 
annual responses by 40,111,035 and an increase in burden hours by 
130,572. These changes and adjustments reflect the realization of one-
time burden associated with conforming to new CBP electronic reporting 
requirements since last OMB approval of the information collection that 
we believe no longer applies. Finally, we consolidated related 
information collection activities associated with CFR part 1, subparts 
D (Sec. Sec.  1.70 through 1.81) and E (Sec. Sec.  1.83 through 1.101) 
governing FDA import activities.

    Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08763 Filed 4-23-20; 8:45 am]
 BILLING CODE 4164-01-P


