82_FR_46264 82 FR 46074 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting

82 FR 46074 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 190 (October 3, 2017)

Page Range46074-46075
FR Document2017-21212

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.

Federal Register, Volume 82 Issue 190 (Tuesday, October 3, 2017)
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46074-46075]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21212]



[[Page 46074]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0192]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Establishing and 
Maintaining Lists of U.S. Milk Product Manufacturers/Processors With 
Interest in Exporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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.

DATES: Fax written comments on the collection of information by 
November 2, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0509. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/
Processors With Interest in Exporting--21 U.S.C. 371

OMB Control Number 0910-0509--Extension

    The United States exports a large volume and variety of foods in 
international trade. For certain food products, foreign governments may 
require assurances from the responsible authority of the country of 
origin of an imported food that the processor of the food is in 
compliance with applicable country of origin regulatory requirements. 
With regard to U.S. milk products, FDA is the competent U.S. food 
safety authority to provide this information to foreign governments. 
FDA provides the requested information about processors in the form of 
lists, which are provided to the foreign governments and posted online 
at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
    Currently, FDA provides Chile, China, and the European Union (EU) 
with a list of U.S. milk product manufacturers/processors that: (1) 
Have expressed interest in exporting their products to these countries; 
(2) are subject to FDA's jurisdiction; and (3) are not the subject of a 
pending enforcement action (i.e., an injunction or seizure or a pending 
warning letter).
    FDA has published guidance documents for these countries under the 
authority of section 701(h) of the Federal, Food, Drug, and Cosmetic 
Act (21 U.S.C. 371(h)), which authorizes the Secretary of Health and 
Human Services (the Secretary) to develop guidance documents with 
public participation presenting the views of the Secretary on matters 
under the jurisdiction of FDA.
    The guidance documents explain what information manufacturers/
processors should submit to FDA to be considered for inclusion on the 
lists and what criteria FDA intends to use to determine eligibility for 
placement on the lists. The guidance documents also explain how FDA 
intends to update the list and communicate any new information to the 
government that requested the list. Finally, the guidance documents 
note that the information is provided voluntarily by manufacturers/
processors with the understanding that it will be posted on FDA's 
external Web site and communicated to, and possibly further 
disseminated by, the government that requested the list; thus, FDA 
considers the information on the lists to be information that is not 
protected from disclosure under 5 U.S.C. 552(b)(4).
    Application for inclusion on each list is voluntary. However, some 
foreign governments may require inclusion on the list for acceptance of 
imported food. FDA recommends that U.S. manufacturers/processors that 
want to be placed on the export lists send FDA the following 
information: (1) Country to which the milk manufacturer/processor wants 
to export product; (2) type of milk product facility; (3) the Food 
Facility Registration Module number (the information collected by this 
module is approved under OMB control number 0910-0502); (4) name and 
address of the firm and the manufacturing plant; (5) name, telephone 
number, and email address of the contact person; (6) list of products 
divided into three categories: Presently shipped, ready to ship, and 
available for shipment in the next 3 years; (7) identities of Agencies 
that inspected the plant; (8) date of last inspection, plant number, 
and copy of last inspection notice; and (9) if other than an FDA 
inspection, copy of last inspection report.
    We request that this information be updated every 2 years.
    We use the information submitted by firms to determine their 
eligibility for placement on the export lists, which are published on 
our Web site. The purpose of the lists is to help foreign governments 
in their determinations of which U.S. milk product manufacturers and 
processors are eligible to export to their respective countries.
    FDA has recently developed an electronic registry system (Form FDA 
3972) that allows milk product manufacturers and processors to 
electronically send a request to FDA to be included on the export 
lists. Manufacturers and processors that prefer to submit a paper 
request in a format of their own choosing will still have the option to 
do so. Electronic Form FDA 3972 collects the same information as is 
currently collected via the existing paper-based process. Draft 
screenshots of Form FDA 3972 and instructions are available at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm and is entitled ``Dairy Listing Module.''
    Description of Respondents: Respondents to this collection of 
information include U.S. milk product manufacturers/processors subject 
to FDA jurisdiction that wish to export to certain foreign countries 
that require inclusion on export lists.
    In the Federal Register of June 15, 2017 (82 FR 27485), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received three comments, however, they 
were not responsive to the four collection of information topics 
solicited and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 46075]]



                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
New requests to be placed on the lists......           2,000               1           2,000  1.........................................           2,000
Biennial update.............................           2,000               1           2,000  0.5 (30 minutes)..........................           1,000
Occasional updates..........................             200               1             200  0.5 (30 minutes)..........................             100
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           3,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate on the number of manufacturers/processors 
that have submitted new written requests, biennial updates, and 
occasional updates over the past 10 years. The estimate of the number 
of burden hours it will take a manufacturer/processor to gather the 
information needed to be placed on the list or update its information 
is based on FDA's experience with manufacturers/processors submitting 
similar requests. FDA believes that the information to be submitted 
will be readily available to manufacturers/processors. This collection 
is also incorporating information collected to maintain lists of 
eligible exporters of dairy products who wish to export to the EU from 
OMB control number 0910-0320, ``Request for Information from U.S. 
Processors that Export to the European Community.''
    FDA estimates that 2,000 firms will average 60 minutes (1 hour) to 
submit new requests for inclusion on the list, 2,000 firms will average 
30 minutes (0.5 hour) to update their information every 2 years, and 
200 firms will average 30 minutes (0.5 hour) to occasionally update 
their information in this system. We also believe that submission via 
the electronic registry system will not affect the burden estimates. An 
electronic registry will enhance the ability of firms to more 
efficiently request inclusion on export lists. FDA calculates, 
therefore, that the total burden for this collection is 3,100 hours 
((2,000 x 1) plus (2,000 x 0.5) plus (200 x 0.5)).

    Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21212 Filed 10-2-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                    46074                        Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices

                                                    DEPARTMENT OF HEALTH AND                                imported food that the processor of the               Food Facility Registration Module
                                                    HUMAN SERVICES                                          food is in compliance with applicable                 number (the information collected by
                                                                                                            country of origin regulatory                          this module is approved under OMB
                                                    Food and Drug Administration                            requirements. With regard to U.S. milk                control number 0910–0502); (4) name
                                                    [Docket No. FDA–2014–N–0192]                            products, FDA is the competent U.S.                   and address of the firm and the
                                                                                                            food safety authority to provide this                 manufacturing plant; (5) name,
                                                    Agency Information Collection                           information to foreign governments.                   telephone number, and email address of
                                                    Activities; Submission for Office of                    FDA provides the requested information                the contact person; (6) list of products
                                                    Management and Budget Review;                           about processors in the form of lists,                divided into three categories: Presently
                                                    Comment Request; Establishing and                       which are provided to the foreign                     shipped, ready to ship, and available for
                                                    Maintaining Lists of U.S. Milk Product                  governments and posted online at                      shipment in the next 3 years; (7)
                                                    Manufacturers/Processors With                           https://www.fda.gov/Food/                             identities of Agencies that inspected the
                                                    Interest in Exporting                                   GuidanceRegulation/ImportsExports/                    plant; (8) date of last inspection, plant
                                                                                                            Exporting/default.htm.                                number, and copy of last inspection
                                                    AGENCY:    Food and Drug Administration,                   Currently, FDA provides Chile, China,              notice; and (9) if other than an FDA
                                                    HHS.                                                    and the European Union (EU) with a list               inspection, copy of last inspection
                                                    ACTION:   Notice.                                       of U.S. milk product manufacturers/                   report.
                                                                                                            processors that: (1) Have expressed                      We request that this information be
                                                    SUMMARY:   The Food and Drug
                                                                                                            interest in exporting their products to               updated every 2 years.
                                                    Administration (FDA) is announcing
                                                                                                            these countries; (2) are subject to FDA’s                We use the information submitted by
                                                    that a proposed collection of
                                                                                                            jurisdiction; and (3) are not the subject             firms to determine their eligibility for
                                                    information has been submitted to the
                                                                                                            of a pending enforcement action (i.e., an             placement on the export lists, which are
                                                    Office of Management and Budget
                                                                                                            injunction or seizure or a pending                    published on our Web site. The purpose
                                                    (OMB) for review and clearance under
                                                                                                            warning letter).                                      of the lists is to help foreign
                                                    the Paperwork Reduction Act of 1995.                       FDA has published guidance
                                                    DATES: Fax written comments on the                                                                            governments in their determinations of
                                                                                                            documents for these countries under the               which U.S. milk product manufacturers
                                                    collection of information by November                   authority of section 701(h) of the
                                                    2, 2017.                                                                                                      and processors are eligible to export to
                                                                                                            Federal, Food, Drug, and Cosmetic Act                 their respective countries.
                                                    ADDRESSES: To ensure that comments on                   (21 U.S.C. 371(h)), which authorizes the
                                                    the information collection are received,                                                                         FDA has recently developed an
                                                                                                            Secretary of Health and Human Services
                                                    OMB recommends that written                                                                                   electronic registry system (Form FDA
                                                                                                            (the Secretary) to develop guidance
                                                    comments be faxed to the Office of                                                                            3972) that allows milk product
                                                                                                            documents with public participation
                                                    Information and Regulatory Affairs,                                                                           manufacturers and processors to
                                                                                                            presenting the views of the Secretary on
                                                    OMB, Attn: FDA Desk Officer, FAX:                                                                             electronically send a request to FDA to
                                                                                                            matters under the jurisdiction of FDA.
                                                    202–395–7285, or emailed to oira_                          The guidance documents explain                     be included on the export lists.
                                                    submission@omb.eop.gov. All                             what information manufacturers/                       Manufacturers and processors that
                                                    comments should be identified with the                  processors should submit to FDA to be                 prefer to submit a paper request in a
                                                    OMB control number 0910–0509. Also                      considered for inclusion on the lists and             format of their own choosing will still
                                                    include the FDA docket number found                     what criteria FDA intends to use to                   have the option to do so. Electronic
                                                    in brackets in the heading of this                      determine eligibility for placement on                Form FDA 3972 collects the same
                                                    document.                                               the lists. The guidance documents also                information as is currently collected via
                                                                                                            explain how FDA intends to update the                 the existing paper-based process. Draft
                                                    FOR FURTHER INFORMATION CONTACT: Ila                                                                          screenshots of Form FDA 3972 and
                                                    S. Mizrachi, Office of Operations, Food                 list and communicate any new
                                                                                                            information to the government that                    instructions are available at https://
                                                    and Drug Administration, Three White                                                                          www.fda.gov/Food/
                                                    Flint North, 10A–12M, 11601                             requested the list. Finally, the guidance
                                                                                                            documents note that the information is                GuidanceRegulation/ImportsExports/
                                                    Landsdown St., North Bethesda, MD                                                                             Exporting/ucm496929.htm and is
                                                    20852, 301–796–7726, PRAStaff@                          provided voluntarily by manufacturers/
                                                                                                            processors with the understanding that                entitled ‘‘Dairy Listing Module.’’
                                                    fda.hhs.gov.                                                                                                     Description of Respondents:
                                                                                                            it will be posted on FDA’s external Web
                                                    SUPPLEMENTARY INFORMATION:    In                        site and communicated to, and possibly                Respondents to this collection of
                                                    compliance with 44 U.S.C. 3507, FDA                     further disseminated by, the government               information include U.S. milk product
                                                    has submitted the following proposed                    that requested the list; thus, FDA                    manufacturers/processors subject to
                                                    collection of information to OMB for                    considers the information on the lists to             FDA jurisdiction that wish to export to
                                                    review and clearance.                                   be information that is not protected                  certain foreign countries that require
                                                    Establishing and Maintaining Lists of                   from disclosure under 5 U.S.C.                        inclusion on export lists.
                                                    U.S. Milk Product Manufacturers/                        552(b)(4).                                               In the Federal Register of June 15,
                                                    Processors With Interest in Exporting—                     Application for inclusion on each list             2017 (82 FR 27485), FDA published a
                                                    21 U.S.C. 371                                           is voluntary. However, some foreign                   60-day notice requesting public
                                                                                                            governments may require inclusion on                  comment on the proposed collection of
                                                    OMB Control Number 0910–0509—                           the list for acceptance of imported food.             information. We received three
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                                                    Extension                                               FDA recommends that U.S.                              comments, however, they were not
                                                      The United States exports a large                     manufacturers/processors that want to                 responsive to the four collection of
                                                    volume and variety of foods in                          be placed on the export lists send FDA                information topics solicited and
                                                    international trade. For certain food                   the following information: (1) Country                therefore will not be discussed in this
                                                    products, foreign governments may                       to which the milk manufacturer/                       document.
                                                    require assurances from the responsible                 processor wants to export product; (2)                   FDA estimates the burden of this
                                                    authority of the country of origin of an                type of milk product facility; (3) the                collection of information as follows:




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                                                                                           Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices                                                                                              46075

                                                                                                                  TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                  Number of
                                                                                                                                       Number of                                            Total annual                   Average burden
                                                                                     Activity                                                                   responses per                                                                                Total hours
                                                                                                                                      respondents                                            responses                      per response
                                                                                                                                                                  respondent

                                                    New requests to be placed on the lists ...................                                      2,000                            1                   2,000        1 ................................            2,000
                                                    Biennial update ........................................................                        2,000                            1                   2,000        0.5 (30 minutes) ........                     1,000
                                                    Occasional updates .................................................                              200                            1                     200        0.5 (30 minutes) ........                       100

                                                          Total ..................................................................   ........................   ........................   ........................   ....................................          3,100
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                       FDA bases its estimate on the number                                   DEPARTMENT OF HEALTH AND                                                     instructions for submitting comments.
                                                    of manufacturers/processors that have                                     HUMAN SERVICES                                                               Comments submitted electronically,
                                                    submitted new written requests,                                                                                                                        including attachments, to https://
                                                    biennial updates, and occasional                                          Food and Drug Administration                                                 www.regulations.gov will be posted to
                                                    updates over the past 10 years. The                                                                                                                    the docket unchanged. Because your
                                                                                                                              [Docket No. FDA–2017–D–5767]
                                                    estimate of the number of burden hours                                                                                                                 comment will be made public, you are
                                                    it will take a manufacturer/processor to                                  Abbreviated New Drug Applications for                                        solely responsible for ensuring that your
                                                    gather the information needed to be                                       Certain Highly Purified Synthetic                                            comment does not include any
                                                    placed on the list or update its                                          Peptide Drug Products That Refer to                                          confidential information that you or a
                                                    information is based on FDA’s                                             Listed Drugs of Recombinant                                                  third party may not wish to be posted,
                                                    experience with manufacturers/                                            Deoxyribonucleic Acid Origin; Draft                                          such as medical information, your or
                                                    processors submitting similar requests.                                   Guidance for Industry; Availability                                          anyone else’s Social Security number, or
                                                                                                                                                                                                           confidential business information, such
                                                    FDA believes that the information to be                                   AGENCY:        Food and Drug Administration,                                 as a manufacturing process. Please note
                                                    submitted will be readily available to                                    HHS.                                                                         that if you include your name, contact
                                                    manufacturers/processors. This                                                                                                                         information, or other information that
                                                                                                                              ACTION:       Notice of availability.
                                                    collection is also incorporating                                                                                                                       identifies you in the body of your
                                                    information collected to maintain lists                                   SUMMARY:   The Food and Drug                                                 comments, that information will be
                                                    of eligible exporters of dairy products                                   Administration (FDA or Agency) is                                            posted on https://www.regulations.gov.
                                                    who wish to export to the EU from OMB                                     announcing the availability of a draft                                         • If you want to submit a comment
                                                    control number 0910–0320, ‘‘Request for                                   guidance for industry entitled ‘‘ANDAs                                       with confidential information that you
                                                    Information from U.S. Processors that                                     for Certain Highly Purified Synthetic                                        do not wish to be made available to the
                                                    Export to the European Community.’’                                       Peptide Drug Products That Refer to                                          public, submit the comment as a
                                                       FDA estimates that 2,000 firms will                                    Listed Drugs of rDNA Origin.’’ The                                           written/paper submission and in the
                                                    average 60 minutes (1 hour) to submit                                     Federal Food, Drug, and Cosmetic Act                                         manner detailed (see ‘‘Written/Paper
                                                    new requests for inclusion on the list,                                   (FD&C Act) permits any person to                                             Submissions’’ and ‘‘Instructions’’).
                                                                                                                              submit to the FDA an abbreviated new
                                                    2,000 firms will average 30 minutes (0.5                                                                                                               Written/Paper Submissions
                                                                                                                              drug application (ANDA) to seek
                                                    hour) to update their information every
                                                                                                                              approval to market a generic version of                                        Submit written/paper submissions as
                                                    2 years, and 200 firms will average 30                                    a previously approved drug product.
                                                    minutes (0.5 hour) to occasionally                                                                                                                     follows:
                                                    update their information in this system.
                                                                                                                              This draft guidance is intended to assist                                      • Mail/Hand delivery/Courier (for
                                                                                                                              potential applicants in determining                                          written/paper submissions): Dockets
                                                    We also believe that submission via the                                   when an application for a synthetic                                          Management Staff (HFA–305), Food and
                                                    electronic registry system will not affect                                peptide drug product (specifically                                           Drug Administration, 5630 Fishers
                                                    the burden estimates. An electronic                                       glucagon, liraglutide, nesiritide,                                           Lane, Rm. 1061, Rockville, MD 20852.
                                                    registry will enhance the ability of firms                                teriparatide, and teduglutide) that refers                                     • For written/paper comments
                                                    to more efficiently request inclusion on                                  to a previously approved peptide drug                                        submitted to the Dockets Management
                                                    export lists. FDA calculates, therefore,                                  product of recombinant                                                       Staff, FDA will post your comment, as
                                                    that the total burden for this collection                                 deoxyribonucleic acid (rDNA) origin                                          well as any attachments, except for
                                                    is 3,100 hours ((2,000 × 1) plus (2,000                                   should be submitted as an ANDA rather                                        information submitted, marked and
                                                    × 0.5) plus (200 × 0.5)).                                                 than as new drug application (NDA).                                          identified, as confidential, if submitted
                                                      Dated: September 28, 2017.                                              DATES: Submit either electronic or                                           as detailed in ‘‘Instructions.’’
                                                    Anna K. Abram,                                                            written comments on the draft guidance                                         Instructions: All submissions received
                                                                                                                              by December 4, 2017 to ensure that the                                       must include the Docket No. FDA–
                                                    Deputy Commissioner for Policy, Planning,
                                                                                                                              Agency considers your comment on this                                        2017–D–5767 for ‘‘ANDAs for Certain
                                                    Legislation, and Analysis.
                                                                                                                              draft guidance before it begins work on                                      Highly Purified Synthetic Peptide Drug
                                                    [FR Doc. 2017–21212 Filed 10–2–17; 8:45 am]
                                                                                                                              the final version of the guidance.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                                                                                                                           Products That Refer to Listed Drugs of
                                                    BILLING CODE 4164–01–P
                                                                                                                              ADDRESSES: You may submit comments                                           rDNA Origin.’’ Received comments will
                                                                                                                              on any guidance at any time as follows:                                      be placed in the docket and, except for
                                                                                                                                                                                                           those submitted as ‘‘Confidential
                                                                                                                              Electronic Submissions                                                       Submissions,’’ publicly viewable at
                                                                                                                                Submit electronic comments in the                                          https://www.regulations.gov or at the
                                                                                                                              following way:                                                               Dockets Management Staff between 9
                                                                                                                                • Federal eRulemaking Portal:                                              a.m. and 4 p.m., Monday through
                                                                                                                              https://www.regulations.gov. Follow the                                      Friday.


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Document Created: 2017-10-03 01:01:27
Document Modified: 2017-10-03 01:01:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by November 2, 2017.
ContactIla S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation82 FR 46074 

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