[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 318-320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed renewal of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on information collection associated with FDA import 
activities.

DATES: Submit either electronic or written comments on the collection 
of information by March 3, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 3, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-1423 for ``Submission of Food and Drug Administration Import 
Data in the Automated Commercial Environment.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's

[[Page 319]]

estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.

Imports and Electronic Import Entries

OMB Control Number 0910-0046--Revision

    This information collection supports Agency regulations in 21 CFR 
part 1, which govern FDA import activities. 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. The data elements allow 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 1.75 
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 a 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, 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 
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 the FDA, and check the estimated laboratory analysis completion 
dates for lines which have been sampled. For further information 
regarding ITACS, please visit our website at https://www.fda.gov/industry/import-systems/itacs.
    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.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                           Number of
        21 CFR part 1; subpart D            Number of    responses per   Total annual               Average burden per response              Total hours
                                           respondents    respondent       responses
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Importers submission of data elements           85,480           10.05         859,074  0.05576 hours (3.346 minutes).....................        47,902
 (preparing the required information).
Entry filers (unique lines only)........         3,419          12,196      41,698,124  0.04466 hours (2.68 minutes)......................     1,862,238
WEF participants........................            15               1              15  0.87 hours (52 minutes)...........................         13.05
ITACS; creation of account..............           500               1               1  1.................................................           250
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    Total...............................  ............  ..............      42,557,214  ..................................................     1,910,403
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\1\ There are no capital or operational and maintenance costs associated with the information collection.

    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 are updating 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. Using these numbers, we update the number of 
importers to 85,480 and the number of entry filers to 3,419. We retain 
our currently approved estimate with regard to the number of responses 
per respondent and time per response as representative of the industry 
average.
    Persons wishing to file weekly entries of FDA regulated products 
are encouraged to provide the information identified so that FDA can 
conduct a

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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 seven-day 
period.
    Finally, since developing and implementing ITACS we believe that 
most respondents to the information collection have realized the one-
time burden associated with creating an account and we have therefore 
adjusted our estimate downward by 2,500 hours. At the same time, we 
retain our estimate that 500 new accounts will be established annually 
for a total of 250 burden hours.
    Cumulatively these changes and adjustments result in a reduction in 
annual responses by 40,112,208, and an increase in burden hours by 
124,891. 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, together with the consolidation of 
related information collection activities associated with ITACS.

    Dated: December 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28419 Filed 1-2-20; 8:45 am]
 BILLING CODE 4164-01-P


