IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the OMB under the Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. 3501-3520). A

description of these provisions is given in the Description portion of
this section with an estimate of the annual reporting burden. Included
in the estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each 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 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.
    Title: Importer's Entry Notice (OMB Control Number 0910-0046).
    Description of Respondents: The respondents to this collection of
information are domestic and foreign ``importers of record'' of FDA-
regulated articles being offered for import into the United States. An
``importer of record'' may be the owner or purchaser of the article
being imported, 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.
    Using the estimates in the Preliminary Regulatory Impact Analysis
(PRIA) for the proposed rule (Ref. 4), we have estimated there are
about 59,292 owners or purchasers who seek to import FDA-regulated
articles into the United States on an annual basis, and we have
estimated that 97.7 percent of these owners or purchasers will use
customs brokers to file their import entries in ACE, and the other 2.3
percent will file their import entries themselves. We estimate that
there are a total of 4,010 filers, which includes the 1,364 owners or
purchasers of the article who will file their own import entry in ACE
(= 59,292 owners or purchasers of the article offered for import x
(100-97.7) percent).
    Description: FDA is proposing to revise the information collection
request (ICR) currently approved under OMB Control Number 0910-0046 to
account for the provisions of the proposed rule that provide for
collection of information from importers via ACE. This ICR (titled
``Importer's Entry Notice'') was most recently approved by OMB on June
30, 2014, and received an expiration date of June 30, 2017. The
currently approved collection of information allows the collection of
several FDA data elements in ACS specific to FDA-regulated products in
order for FDA to make import admissibility decisions. The ICR currently
covers the following data elements for all FDA-regulated products: (1)
FDA Product Code; (2) FDA country of production; (3) FDA manufacturer
and shipper; and (4) ultimate consignee, as well as various
affirmations of compliance specific to certain types of FDA-regulated
products which an importer may submit to FDA to help facilitate FDA's
review process. In making admissibility decisions FDA also uses
additional entry information that CBP regulations require importers to
submit (such as the entry number, importer of record, country of
origin, etc.), but that information is collected under CBP statutes and
regulations and ICRs managed by CBP (e.g., 19 U.S.C. 1484 and 1448(b),
19 CFR 142.3, 142.16, 142.22, and 142.24, and the associated ICR
approved by OMB under OMB Control Number 1651-0024). The annual
recordkeeping requirements for this collection are covered by the
``Customs Modernization Act Recordkeeping Requirements'' information
collection approved by OMB under OMB Control Number 1651-0076.
    The proposed rule and information collection would streamline FDA's
admissibility review of FDA-regulated products, promote more effective
utilization of industry and FDA resources, including electronic
screening technology, and support FDA's ability to continue to meet its
statutory responsibilities under the FD&C Act and the PHS Act. The
information collection aspects of the proposed rule would specify the
FDA-specific data elements that would be required as part of an import
entry submitted in ACE for the FDA-regulated products covered by the
proposed rule being imported or offered for import into the United
States. Most data elements that would be collected in ACE under the
proposed rule, with certain exceptions as explained below, are
currently collected in ACS and approved for collection by OMB under OMB
Control Number 0910-0046. Furthermore, under the proposed rule two of
the data elements currently collected in ACS--FDA manufacturer and
shipper and the ultimate consignee--would no longer be collected in ACE
or any other CBP-authorized EDI system.
    The authority to issue this proposed regulation and to conduct the
associated information collection is found in sections 801, 701 and 536
of the FD&C Act, sections 351, 361, and 368 of the PHS Act, and section
713 of FDASIA (which added section 801(r) to the FD&C Act).
    The information collection provisions of the proposed rule are in
proposed Sec. Sec.  1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and
1.80. Proposed Sec.  1.72 would require certain product identifying
data elements and entity identifying data elements to be submitted in
ACE at the time of entry for food as applicable, drugs, biological
products, HCT/Ps, medical devices, radiation-emitting electronic
products, cosmetics, and tobacco products. Proposed Sec. Sec.  1.73
through 1.80 would require certain data elements to be submitted in ACE
depending on the type of FDA-regulated article being imported or
offered for import into the United States. Proposed Sec. Sec.  1.73,
1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 1.80 apply, respectively, to
certain food products; human drugs; animal drugs; medical devices;
radiation-emitting electronic products; biological products, HCT/Ps,
and related drugs and medical devices regulated by CBER; tobacco
products; and cosmetics.
    All but four of the data elements that proposed subpart D would
require filers to submit in ACE are currently collected in ACS and
already approved for collection under OMB Control Number 0910-0046. Two
of these four new data elements would be required by proposed Sec.
1.72, which applies to certain foods as applicable, and drugs,
biological products, HCT/Ps, medical devices, radiation-emitting
electronic products, cosmetics, and tobacco products, and are the name,
telephone number and email address for one of the persons related to
the importation of the product, which may include the manufacturer,
shipper, importer of record, or Deliver to Party, and a telephone
number and email address for the importer of record, which we need to
facilitate electronic notice under Sec.  1.94 for certain FDA actions.
The other two new data elements would be required by proposed Sec.
1.79, which applies only to tobacco products, and are the name and
address of the ACE filer and brand name of the tobacco product.
    FDA concludes that the proposed data element of a telephone number
and email address for the importer of record (which would be required
by proposed Sec.  1.72(b)(ii)) is not subject to the requirements of
the PRA because the data element falls under an exception to

the term ``information'' under 5 CFR 1320.3(h)(1).
    Under the currently approved ICR, the average time that it takes a
filer to obtain and submit the four data elements and relevant
affirmations of compliance information currently collected in ACS for
all lines in an import entry is estimated at 8.4 minutes (0.14 hours).
We did not receive any comments on the estimated burden enumerated in
the ICR or its estimate of an average of 8.4 minutes per entry. This
estimate of 8.4 minutes includes the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing, reviewing, and filing each entry. The estimate
of 8.4 minutes is an average time across all import entries for FDA-
regulated products and it accounts for the various realities of the
entry filing process, such as the fact that the vast majority of lines
(approximately 97 percent) are not unique lines, even unique lines in a
single entry may contain redundant information, filers use
sophisticated software that facilitates the entry filing process, and
the time required per line may vary depending on the commodity and the
specific characteristics of the product, manufacturer, etc.
    Because two of the data elements that are currently collected in
ACS--FDA manufacturer and shipper and the ultimate consignee--will not
be collected in ACE or any other CBP-authorized EDI system under the
proposed rule, we are reducing this estimate of 8.4 minutes to an
estimate of 7.4 minutes.
    In 2014, when OMB most recently approved this ICR, there was an
average of 4.166 lines per entry for FDA-regulated products. We are
converting the average of 7.4 minutes per entry into the average time
per line. Therefore, the estimated time per import line that it takes a
filer to submit the data elements that are currently approved under OMB
Control Number 0910-0046 and would be submitted in ACE pursuant to the
proposed rule, is approximately 1.776 minutes or 0.0296 hours (= 7.4
minutes / 4.166 lines).
    The current estimated burden for this information collection
approved under OMB Control Number 0910-0046, updated to account for the
total number of FDA-regulated product lines submitted in ACS in 2015
(approximately 34 million lines) and annualized to account for
estimated 3.3 percent increases in year two and three (for an
annualized average of 35,133,681 lines in years one, two, and three),
but not accounting for the estimated additional burden of the proposed
rule for those lines that would be affected by the proposed rule, is
approximately 1,039,957 hours (= 35,133,681 lines x 0.0296 hours).
    Using the estimates in the PRIA for the proposed rule, we have
estimated that 33,988,154 import lines will be impacted by the proposed
rule in the first year. We have also estimated that 975,460 import
lines in the first year represent unique product-manufacturer
combinations (2.87 percent of the 33,988,154 import lines). We have
estimated that the number of impacted import lines will grow at an
average rate of about 3.3 percent per year.
    Other key assumptions in Option 1 of the PRIA for the proposed rule
that affect our estimate of the additional annual reporting burden are:
     Respondents would have to become aware of the rule
requirements, which include activities related to reading the rule,
understanding the reporting requirements, consulting with specialists
if necessary, determining how to best meet these requirements and
communicating these requirements to workers; and this is a one-time
event that would require an average of 30 minutes.
     Respondents would require an administrative worker to
locate, gather, and prepare the additional information required by this
rule for each unique product-manufacturer import line; and this would
require about 4 minutes (0.0667 hours) per line on average. Because FDA
has concluded that the proposed data element of a telephone number and
email address for the importer of record (which would be required by
proposed Sec.  1.72(b)(ii)) is not subject to the requirements of the
PRA, we have reduced this estimated time to 3.8 minutes for PRA
purposes (approximately 0.0633 hours).
     Respondents would require an administrative worker to
complete entry request for each import line and quality check using
software that is connected to ACE, and that this would require about 2
minutes (0.033 hours) per line on average. Because FDA has concluded
that the proposed data element of a telephone number and email address
for the importer of record (which would be required by proposed Sec.
1.72(b)(ii)) is not subject to the requirements of the PRA, we have
reduced this estimated time to 1.8 minutes (0.03 hours) for PRA
purposes.
     It would take respondents about 12.5 percent more time in
the first year for an administrative worker to complete an entry
request for each import line and quality check using software that is
connected to ACE because they would have to adjust to the new system
and data elements.
    We have found based on our experience that filers no longer need to
take a long time to familiarize themselves with changes in laws and
rules relating to imports to determine how those changes would apply to
an article being imported or offered for import, because much of these
updates are now software-driven. For example, importers often rely on
the electronic messages CBP sends to them notifying them of changes to
data requirements. Furthermore, the proposed rule is fairly short, not
complex, and does not require an inordinate number of data elements to
be submitted in ACE for an FDA-regulated product.
    Additionally, most of the general data elements that would be
required by proposed Sec.  1.72 of the proposed rule are currently
collected in ACS, so filers should be very familiar with them. Almost
all the data elements that would be required by the proposed rule in
proposed Sec. Sec.  1.73 through 1.80 have also been available for
submission in ACS as Affirmations of Compliance and have been described
in various FDA memoranda to the U.S. import trade community, so most
filers should be generally familiar with them as well.
    Entry filing processes have evolved technologically over time. The
vast majority of filers currently rely on sophisticated software, which
interacts with ACS and can be programmed to interact with ACE, to
perform many of the tasks and functions that were previously performed
manually, such as flagging mandatory data fields, providing quality
checks, and record keeping. This increased reliance on sophisticated
software has substantially reduced the entry filing burden. Importers
also rely on the ACE system to flag mandatory data submissions and show
an error message when an entry is rejected because a required data
field is empty or is not completed in the required manner.
    Our estimate of the increase in the reporting burden from the
proposed rule primarily accounts for the proposed rule requiring
submission of some data elements in ACE that are currently routinely
collected submissions in ACS. We expect that some filers who were not
submitting these data elements in ACS would have to change their
submissions to comply with the proposed rule, if finalized. The annual
reporting burden is higher in the first year than in years after
because we expect most filers to adapt to submitting the required data
they had not been submitting in ACS and to electronically store such
data for future repeat lines.
    Of note, FDA data shows that submission rates for the data elements

currently collected in ACS for many products are quite high. For
example, for medical device lines, which make up approximately half of
all import lines (based on 2014 and 2015 data) that would be affected
by the proposed rule, approximately 98 percent are submitted with at
least one affirmation of compliance, with an average of approximately
three affirmations of compliance per line. Further, it appears that
most medical device lines submitted in 2014 and 2015 through ACS
already include most of the information that would be required in ACE
by the proposed rule. Additionally, cosmetic products, which make up
approximately 8 percent of all import lines (based on 2014 and 2015
data) that would be affected by the proposed rule, would require no
submission of information in ACE under the proposed rule other than the
general data elements specified in proposed Sec.  1.72.
    As we noted previously, we have estimated that the number of import
lines affected by the proposed rule will grow at an average rate of
about 3.3 percent per year. For the purposes of calculating the
additional annual recurring reporting burden of the proposed rule, we
have annualized those 3.3 percent per year increases for 3 years.
Accordingly, we expect the additional annual recurring reporting burden
for the information collection that would result from this proposed
rule, once finalized, to be as follows:

                       Table 2--Estimated Additional Annual Recurring Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
                                    No. of       responses per   Total annual    Average burden
           Activity               respondents     respondent       responses    per response (in    Total hours
                                                 (approximate)                       hours)
----------------------------------------------------------------------------------------------------------------
Preparing the required                  59,292           17.01       1,008,337  0.0633..........          63,828
 information (applies to                                                        (3.8 minutes)...
 unique lines only).
Quality checks and data                  4,010           8,762      35,113,681  0.03............       1,053,410
 submission into ACE.                                                           (1.8 minutes)...
                               ---------------------------------------------------------------------------------
    Total Hours...............  ..............  ..............  ..............  ................       1,117,238
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We expect the additional one-time (i.e., occurring only in the
first year) reporting burden for the information collection that would
result from this proposed rule, if finalized, to be as follows:

                                Table 3.--Estimated One Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
                                    No. of       responses per   Total annual    Average burden
           Activity               respondents     respondent       responses    per response (in    Total hours
                                                 (approximate)                       hours)
----------------------------------------------------------------------------------------------------------------
Review and familiarization               4,010               1           4,010  .5..............           2,005
 with the rule.                                                                 (30 minutes)....
First year adjusting to new              4,010           8,476      33,988,154  .00375..........         127,456
 requirements that would                                                        (0.225 minutes).
 result in an average of 12.5
 percent more time for quality
 checks and submission into
 ACE.
                               ---------------------------------------------------------------------------------
Total Hours...................  ..............  ..............  ..............  ................         129,461
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Accordingly, we estimate that the additional annual reporting
burden under the proposed rule, if finalized, would be 1,246,699 hours
in the first year and 1,117,238 hours recurring after the first year.
    As noted previously, the current estimated burden for this
information collection, updated to account for the number of total FDA-
regulated lines submitted to FDA in 2015 and an estimated 3.3 percent
per year increase in lines in years two and three, but not accounting
for the estimated additional burden of the proposed rule, is 1,039,957
hours. Therefore, we estimate that the total burden under this ICR,
revised to include the estimated additional annual reporting burden
under the proposed rule in addition to the current annual reporting
burden, would be 2,286,656 hours in the first year (= 1,039,957 current
burden + 1,117,238 recurring burden + 129,461 one-time burden) and
2,157,195 hours annually after the first year (= 1,039,957 current
burden + 1,117,238 recurring burden).
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has
submitted the information collection provisions of this proposed rule
to OMB for review. To ensure that comments on information collection
are received, OMB recommends that written comments be faxed or emailed
(see ADDRESSES). These requirements will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these requirements in the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that would have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Accordingly, we conclude that the rule does not contain policies that
have federalism implications as defined in the Executive order and,
consequently, a federalism

summary impact statement is not required.

XI. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

    1. Automated Commercial System and ABI CATAIR, CBP http://www.cbp.gov/trade/acs/catair (April 13, 2016).
    2. FDA Guidance for Industry: Submitting Form FDA 2541 (Food
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e,
FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in
Electronic or Paper Format. November 2015. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm309376.htm.
    3. FDA Draft Guidance for Industry: Implementation of the
``Deemed to be a License'' Provision of the Biologics Price
Competition and Innovation Act of 2009. March 2016. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm490264.pdf.
    4. FDA, Full Disclosure of Preliminary Regulatory Impact
Analysis, Initial Regulatory Flexibility Analysis, and Unfunded
Mandates Reform Act Analysis on Regulations on Electronic Submission
of Import Data: Automated Commercial Environment Proposed Rule.
Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food Labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 1005

    Administrative practice and procedure, Electronic products,
Imports, Radiation protection, Surety bonds.

21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical
devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that parts 1, 1005, and
1271 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343,
350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362,
371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241,
243, 262, 264.

0
2. Add subpart D, consisting of Sec. Sec.  1.70 through 1.80, to read
as follows:
Subpart D--Electronic Import Entries
Sec.
1.70 Scope.
1.71 Definitions.
1.72 Data elements that must be submitted in ACE for articles
regulated by FDA.
1.73 Food.
1.74 Human drugs.
1.75 Animal drugs.
1.76 Medical devices.
1.77 Radiation-emitting electronic products.
1.78 Biological products, HCT/Ps, and related drugs and medical
devices.
1.79 Tobacco products.
1.80 Cosmetics.

Subpart D--Electronic Import Entries

Sec.  1.70  Scope.

    This subpart specifies the data elements that are required by the
Food and Drug Administration (FDA) to be included in an electronic
import entry submitted in the Automated Commercial Environment (ACE)
system or any other U.S. Customs and Border Protection (CBP)-authorized
electronic data interchange (EDI) system operated by the CBP, which
contains an article that is being imported or offered for import into
the United States and that is regulated by FDA.

Sec.  1.71  Definitions.

    For purposes of subpart D:
    ACE filer means the person who is authorized to submit an
electronic import entry for an FDA-regulated product in the Automated
Commercial Environment or any other CBP-authorized EDI system.
    Acidified food means acidified food, as defined in Sec.  114.3(b)
of this chapter, and subject to the requirements in parts 108 and 114
of this chapter.
    Automated Commercial Environment or ACE means the automated and
electronic system for processing commercial importations that is
operated by the United States Customs and Border Protection in
accordance with the National Customs Automation Program established in
Subtitle B of Title VI--Customs Modernization, in the North American
Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat.
2057, 2170, December 8, 1993) (Customs Modernization Act), or any other
CBP-authorized EDI system.
    Biological product means a biological product as defined in section
351(i)(1) of the Public Health Service Act.
    Combination product means a product comprised of two or more
regulated components as defined in Sec.  3.2(e) of this chapter.
    Cosmetic means a cosmetic as defined in section 201(i) of the
Federal Food, Drug, and Cosmetic Act.
    Customs and Border Protection or CBP means the Federal Agency
within the Department of Homeland Security that is primarily
responsible for maintaining the integrity of the borders and ports of
entry in the United States.
    Drug means those articles meeting the definition of a drug in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.
    FDA or Agency means the U.S. Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act.
    Food contact substance means any substance, as defined in section
409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended
for use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food.
    HCT/Ps means human cells, tissues or cellular or tissue-based
products, as defined in Sec.  1271.3(d) of this chapter.
    Import line means each portion of an import entry that is listed as
a separate item on an entry document.
    Low-acid canned food means a thermally processed low-acid food (as
defined in Sec.  113.3(n) of this chapter) in a hermetically sealed
container (as defined in Sec.  113.3(j) of this chapter), and subject
to the requirements in parts 108 and 113 of this chapter.
    Medical device means a device as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act, that is intended for use in
humans.
    Radiation-emitting electronic product means an electronic product
as defined in section 531 of the Federal Food, Drug, and Cosmetic Act.
    Tobacco product means a tobacco product as defined in section
201(rr) of the Federal Food, Drug, and Cosmetic Act.

Sec.  1.72  Data elements that must be submitted in ACE for articles
regulated by FDA.

    General. When filing an entry in ACE, the ACE filer shall submit
the following

information for food as applicable, and drugs, biological products,
HCT/Ps, medical devices, radiation-emitting electronic products,
cosmetics, and tobacco products.
    (a) Product identifying information for the article that is being
imported or offered for import. This consists of:
    (1) FDA Country of Production, which is, the country where the
article was last manufactured, processed, or grown (including
harvested, or collected and readied for shipment to the United States).
The FDA Country of Production for an article that has undergone any
manufacturing or processing is the country where that activity occurred
provided that the manufacturing or processing had more than a minor,
negligible, or insignificant effect on the article.
    (2) The Complete FDA Product Code, which must agree with the
invoice description of the product.
    (3) FDA Value which is the total value of the article(s) in an
import entry or import line, rounded off to the nearest dollar, which
must match the invoice value of those article(s).
    (4) FDA Quantity which is the quantity of the article(s) in an
import line delineated by packaging level, including the type of
package from the largest packaging unit to the smallest packaging unit;
the quantity of each packaging unit; and the volume and/or weight of
each of the smallest of the packaging units.
    (b) Entity Identification Information, (1) Name, telephone, and
email address of any one of the persons related to the importation of
the product which may include the manufacturer, shipper, importer of
record, or Deliver to Party.
    (2) Telephone and email address of the importer of record.

Sec.  1.73  Food.

    (a) Food. The information specified in Sec.  1.72(a)(3) must be
submitted in ACE at the time of filing entry for food.
    (b) Food contact substances. The information specified in Sec.
1.72 must be submitted in ACE at the time of filing entry for food that
is a food contact substance.
    (c) Low-acid canned food. For an article of food that is a low-acid
canned food, the ACE filer must submit at the time of filing entry the
Food Canning Establishment Number and the Submission Identifier, and
can dimensions or volume.
    (d) Acidified food. For an article of food that is an acidified
food, the ACE filer must submit at the time of filing entry the Food
Canning Establishment Number and the Submission Identifier, and can
dimensions or volume.

Sec.  1.74  Human drugs.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit the following information at the time of filing
entry for drugs, including biological products, intended for human use
that are regulated by the FDA Center for Drug Evaluation and Research.
    (a) Registration and listing. For a drug intended for human use,
the Drug Registration Number and the Drug Listing Number. For the
purposes of this section, the Drug Registration Number that must be
submitted in ACE is the unique facility identifier of the foreign
establishment where the human drug was manufactured, prepared,
propagated, compounded or processed before being imported or offered
for import into the United States. The unique facility identifier is
the identifier submitted by a registrant in accordance with the system
specified under section 510(b) of the Federal Food, Drug, and Cosmetic
Act. For the purposes of this section, the Drug Listing Number is the
National Drug Code number of the human drug article being imported or
offered for import.
    (b) Drug application number. For a drug intended for human use that
is the subject of an approved application under section 505(b) or
505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the
new drug application or abbreviated new drug application. For a
biological product regulated by the FDA Center for Drug Evaluation and
Research that is required to have an approved new drug application or
an approved biologics license application, the number of the applicable
application.
    (c) Investigational new drug application number. For a drug
intended for human use that is the subject of an investigational new
drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act, the number of the investigational new drug application.

Sec.  1.75  Animal drugs.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit the following information at the time of filing
entry for animal drugs:
    (a) Registration and listing. For a drug intended for animal use,
the Drug Registration Number and the Drug Listing Number for the
purposes of this section, the Drug Registration Number that must be
submitted in ACE is the Unique Facility Identifier of the foreign
establishment where the animal drug was manufactured, prepared,
propagated, compounded or processed before being imported or offered
for import into the United States. The Unique Facility Identifier is
the identifier submitted by a registrant in accordance with the system
specified under section 510(b) of the Federal Food, Drug, and Cosmetic
Act. For the purposes of this section, the Drug Listing Number is the
National Drug Code number of the animal drug article being imported or
offered for import.
    (b) New animal drug application number. For a drug intended for
animal use that is the subject of an approved application under section
512 of the Federal Food, Drug, and Cosmetic Act, the number of the new
animal drug application or abbreviated new animal drug application. For
a drug intended for animal use that is the subject of a conditionally
approved application under section 571 of the Federal Food, Drug, and
Cosmetic Act, the application number for the conditionally approved new
animal drug.
    (c) Veterinary minor species index file number. For a drug intended
for use in animals that is the subject of an Index listing under
section 572 of the Federal Food, Drug, and Cosmetic Act, the Minor
Species Index File number of the new animal drug on the Index of
Legally Marketed Unapproved New Animal Drugs for Minor Species.
    (d) Investigational new animal drug number. For a drug intended for
animal use that is the subject of an investigational new animal drug or
generic investigational new animal drug application under part 511 of
this chapter, the number of the investigational new animal drug or
generic investigational new animal drug file.

Sec.  1.76  Medical devices.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit the following information at the time of filing
entry for medical devices regulated by the FDA Center for Devices and
Radiological Health.
    (a) Registration and listing. For a medical device, the
Registration Number for Foreign Manufacturers, Foreign Exporters, and/
or Domestic Manufacturers, and the Device Listing Number, required
under section 510 of the Federal Food, Drug, and Cosmetic Act and part
807 of this chapter.
    (b) Investigational devices. For an investigational medical device
that has an investigational device exemption granted under section
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational
Device Exemption Number. For an investigational medical device being
imported or offered for import for use in a nonsignificant risk or
exempt study, ``NSR'' to be entered in the Affirmation of Compliance
for the

``investigational device exemption'' that identifies the device as
being used in a nonsignificant risk or exempt study.
    (c) Premarket number. For a medical device that has one, the
Premarket Number. This is the Premarket Approval Number for those
medical devices that have received pre-market approval under section
515 of the Federal Food, Drug, and Cosmetic Act; the Product
Development Protocol Number for those medical devices for which FDA has
declared the product development protocol complete under section 515(f)
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for
those medical devices granted marketing authorization under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket
Notification Number for those medical devices that received premarket
clearance under section 510(k) of the Federal Food, Drug, and Cosmetic
Act; or the Humanitarian Device Exemption Number for those medical
devices for which an exemption has been granted under section 520(m) of
the Federal Food, Drug, and Cosmetic Act.
    (d) Component. If applicable for a medical device, an affirmation
identifying that the article being imported or offered for import is a
component that requires further processing or inclusion into a finished
medical device.
    (e) Lead wire/patient cable. For electrode lead wires and patient
cables intended for use with a medical device, an Affirmation of
Compliance with the applicable performance standard under Sec.  898.12
of this chapter.
    (f) Impact resistant lens. For impact resistant lenses in
eyeglasses and sunglasses, an Affirmation of Compliance with the
applicable requirements of Sec.  801.410 of this chapter.
    (g) Convenience kit. If applicable for a medical device, an
Affirmation of Compliance that the article imported or offered for
import is a convenience kit or part of a convenience kit.
    (h) Investigational new drug application number. For a combination
product consisting of at least one medical device and one drug intended
for human use that is the subject of an investigational new drug
application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act, where the FDA Center for Devices and Radiological Health
has been designated by FDA as the center with primary jurisdiction for
the premarket review and regulation of the combination product, the
number of the investigational new drug application.

Sec.  1.77  Radiation-emitting electronic products.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit all of the declarations required in Form FDA 2877
electronically in ACE at the time of filing entry for products subject
to the standards under parts 1020-1050 of this chapter.

Sec.  1.78  Biological products, HCT/Ps, and related drugs and medical
devices.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit the following information at the time of entry
for biological products, HCT/Ps, and related drugs and medical devices
regulated by the FDA Center for Biologics Evaluation and Research.
    (a) Product name which identifies the article being imported or
offered for import by the name commonly associated with that article
including the established name, trade name, brand name, proper name, or
product description if the article does not have an established name,
trade name, brand name or proper name.
    (b) HCT/P registration and affirmation. (1) For an HCT/P regulated
solely under section 361 of the Public Health Service Act and the
regulations in part 1271 of this chapter that is manufactured by an
establishment that is required to be registered under part 1271 of this
chapter, the HCT/P Registration Number; and
    (2) For an HCT/P regulated solely under section 361 of the Public
Health Service Act and the regulations in part 1271 of this chapter, an
affirmation of compliance with the applicable requirements of part 1271
of this chapter.
    (c) Licensed biological products. For a biological product that is
the subject of an approved biologics license application under section
351 of the Public Health Service Act, the Submission Tracking Number of
the biologics license application and/or the Biologics License Number.
    (d) Drug registration and listing. For a drug intended for human
use, the Drug Registration Number and the Drug Listing Number. For the
purposes of this section, the Drug Registration Number that must be
submitted in ACE is the unique facility identifier of the foreign
establishment where the human drug was manufactured, prepared,
propagated, compounded or processed before being imported or offered
for import into the United States. The unique facility identifier is
the identifier submitted by a registrant in accordance with the system
specified under section 510(b) of the Federal Food, Drug, and Cosmetic
Act. For the purposes of this section, the Drug Listing Number is the
National Drug Code number of the human drug article being imported or
offered for import.
    (e) Drug application number. For a drug intended for human use that
is the subject of an approved application under section 505(b) or
505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the
new drug application or the abbreviated new drug application.
    (f) Investigational new drug application number. For a drug
intended for human use that is the subject of an investigational new
drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act, the number of the investigational new drug application.
    (g) Medical device registration and listing. For a medical device
subject to the registration and listing procedures contained in part
807 of this chapter, the Registration Number for Foreign Manufacturers,
Foreign Exporters, and/or Domestic Manufacturers, and the Device
Listing Number, required under section 510 of the Federal Food, Drug,
and Cosmetic Act and part 807 of this chapter.
    (h) Investigational devices. For an investigational medical device
that has an investigational device exemption granted under section
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational
Device Exemption Number. For an investigational medical device being
imported or offered for import for use in a nonsignificant risk or
exempt study, an Affirmation of Compliance that identifies the device
as being used in such a study.
    (i) Medical device premarket number. For a medical device that has
one, the premarket number. This is the premarket approval number for
those medical devices that have received pre-market approval under
section 515 of the Federal Food, Drug, and Cosmetic Act; the Product
Development Protocol Number for those medical devices for which FDA has
declared the Product Development Protocol complete under section 515(f)
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for
those medical devices granted marketing authorization under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket
Notification Number for those medical devices that received premarket
clearance under section 510(k) of the Federal Food, Drug, and Cosmetic
Act; or the Humanitarian Device Exemption Number for those medical
devices for which an exemption has been granted under section 520(m) of
the Federal Food, Drug, and Cosmetic Act.

    (j) Medical device component. If applicable for a medical device,
an affirmation identifying that the article being imported or offered
for import is a component that requires further processing or inclusion
into a finished medical device.

Sec.  1.79  Tobacco products.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit the following information at the time of filing
entry in ACE.
    (a) Brand name of the article that is a tobacco product being
imported or offered for import.
    (b) Name and address of the ACE filer for any entry that includes
an article that is a tobacco product.

Sec.  1.80  Cosmetics.

    An ACE filer must submit the data specified in Sec.  1.72 at the
time of filing entry in ACE.
0
3. In Sec.  1.83, revise paragraph (a) to read as follows:

Sec.  1.83  Definitions.

* * * * *
    (a) The term owner or consignee means the person eligible to make
entry under the provisions of sections 484 and 485 of the Tariff Act of
1930, as amended (19 U.S.C. 1484 and 1485), namely, the ``importer of
record.''
* * * * *
0
4. Revise Sec.  1.90 to read as follows:

Sec.  1.90  Notice of sampling.

    When a sample of an article offered for import has been requested
by the district director, FDA shall provide to the owner or consignee
prompt notice of delivery of, or intention to deliver, such sample.
Upon receipt of the notice, the owner or consignee shall hold such
article and not distribute it until further notice from the district
director or U.S. Customs and Border Protection of the results of
examination of the sample.
0
5. In Sec.  1.94, revise the first sentence of paragraphs (a) and (c)
to read as follows:

Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of
admission, or that the article is a drug that may be subject to
destruction under section 801(a) of the Federal Food, Drug, and
Cosmetic Act, the district director shall give the owner or consignee a
written or electronic notice to that effect, stating the reasons
therefor. * * *
* * * * *
    (c) If the article is a drug that may be subject to destruction
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the
district director may give the owner or consignee a single written or
electronic notice that provides the notice on refusal of admission and
the notice on destruction of an article described in paragraph (a) of
this section. * * *

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

0
6. The authority citation for part 1005 continues to read as follows:

    Authority:  21 U.S.C. 360ii, 360mm.

0
7. Revise Sec.  1005.2 to read as follows:

Sec.  1005.2  Definitions.

    As used in this part:
    The term owner or consignee means the person eligible to make entry
under the provisions of sections 484 and 485 of the Tariff Act of 1930,
as amended (19 U.S.C. 1484 and 1485), namely, the ``importer of
record.''

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS

0
8. The authority citation for part 1271 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.

0
9. In Sec.  1271.420, revise paragraph (a) to read as follows:

Sec.  1271.420  HCT/Ps offered for import.

    (a) Except as provided in paragraphs (c) and (d) of this section,
when an HCT/P is offered for import, the importer of record must
notify, either before or at the time of importation, the director of
the district of the Food and Drug Administration (FDA) having
jurisdiction over the port of entry through which the HCT/P is imported
or offered for import, or such officer of the district as the director
may designate to act in his or her behalf in administering and
enforcing this part, and must provide sufficient information, including
information submitted in the Automated Commercial Environment (ACE)
system or any other Electronic Data Interchange system authorized by
the United States Customs and Border Protection Agency as required in
part 1, subpart D of this chapter, for FDA to make an admissibility
decision.
* * * * *

    Dated: June 28, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and Drug Administration.

    In concurrence with FDA:

    Dated: June 28, 2016.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy), Department
of the Treasury.
[FR Doc. 2016-15684 Filed 6-30-16; 8:45 am]
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[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8837-8838]
[FR Doc No: 2022-03374]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2020-0670; FRL-9584-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Oil and Natural Gas Production and
Natural Gas Transmission and Distribution (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), NSPS for Oil and Natural Gas
Production and Natural Gas Transmission and Distribution (EPA ICR
Number 2437.05, OMB Control Number 2060-0673), to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through April 30, 2022. Public comments
were previously requested, via the Federal Register, on February 8,
2021 during a 60-day

comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An agency may neither conduct
nor sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before March 18,
2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2020-0670, online using www.regulations.gov (our preferred method)
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov, or in person, at the EPA Docket Center,
WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington,
DC. The telephone number for the Docket Center is<PHONE_NUMBER>. For
additional information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS) for Oil and
Natural Gas Production and Natural Gas Transmission and Distribution
(40 CFR part 60, subpart OOOO) apply to oil and natural gas facilities
that commence construction, modification or reconstruction after August
23, 2011 and on or before September 19, 2015, that are involved in the
extraction and production of oil and natural gas, as well as for the
processing, transmission, and distribution of natural gas. Affected
facilities in the crude oil and natural gas source category that
commence construction, modification, or reconstruction after September
18, 2015 are instead subject to subpart OOOOa (40 CFR 60, subpart
OOOOa). In general, all NSPS standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NSPS.
    Form Numbers: None.
    Respondents/affected entities: Oil and natural gas production and
natural gas transmission and distribution facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart OOOO).
    Estimated number of respondents: 532 (total).
    Frequency of response: Semiannually and annually.
    Total estimated burden: 69,300 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $9,430,000 (per year), which includes
$1,220,000 for annualized capital/startup and/or operation &
maintenance costs.
    Changes in the estimates: There is no change in burden from the
most-recently approved ICR as currently identified in the OMB Inventory
of Approved Burdens. This is due to two considerations: (1) The
regulations have not changed over the past three years and are not
anticipated to change over the next three years; and (2) no new
facilities will become subject to this regulation, so there is no
significant change in the overall burden. Since there are no changes in
the regulatory requirements and there is no significant industry
growth, there are also no changes in the capital/startup or operation
and maintenance (O&M) costs.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-03374 Filed 2-15-22; 8:45 am]
BILLING CODE 6560-50-P