80_FR_34786 80 FR 34670 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act

80 FR 34670 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range34670-34672
FR Document2015-14888

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 80 Issue 116 (Wednesday, June 17, 2015)
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34670-34672]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14888]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0369]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Regulations Under the 
Federal Import Milk Act

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

[[Page 34671]]

(OMB) for review and clearance under the Paperwork Reduction Act of 
1995.

DATES: Fax written comments on the collection of information by July 
17, 2015.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0212. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    Under Federal Import Milk Act (FIMA) (21 U.S.C. 141-149), milk or 
cream may be imported into the United States only by the holder of a 
valid import milk permit (21 U.S.C. 141). Before such permit is issued: 
(1) All cows from which import milk or cream is produced must be 
physically examined and found healthy; (2) if the milk or cream is 
imported raw, all such cows must pass a tuberculin test; (3) the dairy 
farm and each plant in which the milk or cream is processed or handled 
must be inspected and found to meet certain sanitary requirements; (4) 
bacterial counts of the milk at the time of importation must not exceed 
specified limits; and (5) the temperature of the milk or cream at time 
of importation must not exceed 50[emsp14][deg]F (21 U.S.C. 142).
    Our regulations in part 1210 (21 CFR part 1210) implement the 
provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the 
sanitary conditions of, respectively, dairy farms and plants producing 
milk and/or cream to be shipped to the United States. Section 1210.12 
requires reports on the physical examination of herds, while Sec.  
1210.13 requires the reporting of tuberculin testing of the herds. In 
addition, the regulations in part 1210 require that dairy farmers and 
plants maintain pasteurization records (Sec.  1210.15) and that each 
container of milk or cream imported into the United States bear a tag 
with the product type, permit number, and shipper's name and address 
(Sec.  1210.22). Section 1210.20 requires that an application for a 
permit to ship or transport milk or cream into the United States be 
made by the actual shipper. Section 1210.23 allows permits to be 
granted based on certificates from accredited officials.
    In the Federal Register of March 25, 2015 (80 FR 15794), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Number of
          21 CFR  Section                      Form No.              Number of     responses per   Total annual     Average burden per      Total hours
                                                                    respondents     respondent       responses           response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11............................  FDA 1996; Sanitary                        2             200             400  1.5...................             600
                                      Inspection of Dairy Farms.
1210.12............................  FDA 1995; Physical                        1               1               1  0.5 (30 minutes)......             0.5
                                      Examination of Cows.
1210.13............................  FDA 1994; Tuberculin Test..               1               1               1  0.5 (30 minutes)......             0.5
1210.14............................  FDA 1997; Sanitary                        2               1               2  2.....................               4
                                      Inspections of Plants.
1210.20............................  FDA 1993; Application for                 2               1               2  0.5 (30 minutes)......               1
                                      Permit.
1210.23............................  FDA 1815; Permits Granted                 2               1               2  0.5 (30 minutes)......               1
                                      on Certificates.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........................  ..............  ..............  ..............  ......................             607
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                      21 CFR Section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15..................................................                 2                  1                  2               0.05                0.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated number of respondents and hours per response are 
based on our experience with the import milk permit program and the 
average number of import milk permit holders over the past three years. 
We estimate that two respondents will submit approximately 200 Form FDA 
1996 reports annually, for a total of 600 responses. We estimate the 
reporting burden to be 1.5 hours per response, for a total burden of 
607 hours.
    The Secretary of Health and Human Services has the discretion to 
allow Form FDA 1815, a duly certified statement signed by an accredited 
official of a foreign government, to be submitted in lieu of Forms FDA 
1994 and 1995. To date, Form FDA 1815 has been submitted in lieu of 
these forms. Because we have not received any Forms FDA 1994 and 1995 
in the last 3 years, the Agency estimates no more than one will be 
submitted annually. We estimate the reporting burden for each to be 0.5 
hours per response for a total burden reporting burden of 0.5 hours 
each.
    We estimate that two respondents will submit one Form FDA 1997 
report

[[Page 34672]]

annually, for a total of two responses. We estimate the reporting 
burden to be 2 hours per response, for a total burden of 4 hours. We 
estimate that two respondents will submit one Form FDA 1993 report 
annually, for a total of two responses. We estimate the reporting 
burden to be 0.5 hours per response, for a total burden of 1 hour. We 
estimate that two respondents will submit one Form FDA 1815 report 
annually, for a total of two responses. We estimate the reporting 
burden to be 0.5 hours per response, for a total burden of 1 hour.
    With regard to records maintenance, we estimate that approximately 
two recordkeepers will spend 0.05 hours annually maintaining the 
additional pasteurization records required by Sec.  1210.15, for a 
total of 0.10 hours annually.
    No burden has been estimated for the tagging requirement in Sec.  
1210.22 because the information on the tag is either supplied by us 
(permit number) or is disclosed to third parties as a usual and 
customary part of the shipper's normal business activities (type of 
product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the 
public disclosure of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the public 
is not subject to review by the Office of Management and Budget under 
the Paperwork Reduction Act. Under 5 CFR 1320.3(b)(2)), the time, 
effort, and financial resources necessary to comply with a collection 
of information are excluded from the burden estimate if the reporting, 
recordkeeping, or disclosure activities needed to comply are usual and 
customary because they would occur in the normal course of business 
activities.

    Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14888 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                    34670                        Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

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                                                    32. Zock, P. L., M. B. Katan, and R. P.                      Risk of Coronary Heart Disease in Men:            61. Food and Agricultural Organization of the
                                                         Mensink, ‘‘Dietary Trans Fatty Acids and                Cohort Follow Up Study in the United                   United Nations (FAO) and WHO, Fats
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                                                         Carbohydrates on the Ratio of Serum                     341:581–585, 1993.                                     Lifestyle Management to Reduce
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                                                         Cholesterol,’’ Presented at the SOT FDA                 et al., ‘‘Association Between Trans Fatty              EFSA Journal, 81:1–49, 2004.
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                                                    40. Page, I. H., E. V. Allen, F. L. Chamberlain,             Journal of Clinical Nutrition, 65:773–            [FR Doc. 2015–14883 Filed 6–16–15; 8:45 am]
                                                         et al., ‘‘Dietary Fat and Its Relation to               783, 2011.                                        BILLING CODE 4164–01–P
                                                         Heart Attacks and Strokes,’’ Circulation,          55. Chowdhury R., S. Warnakula, S.
                                                         23:133–136, 1961.                                       Kunutsor, et al., ‘‘Association of Dietary,
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                                                                                                                                                                   DEPARTMENT OF HEALTH AND
                                                         Quantitative Meta-Analysis of Metabolic                 Review and Meta-analysis,’’ Annals of             HUMAN SERVICES
                                                         Ward Studies,’’ BMJ, 314:112–117, 1997.                 Internal Medicine, 160:398–406, 2014.
                                                    42. Mensink R. P. and M. B. Katan, ‘‘Effect             56. Trumbo, P. R. and T. Shimakawa,                    Food and Drug Administration
                                                         of Dietary Fatty Acids on Serum Lipids                  ‘‘Tolerable Upper Intake Levels for Trans         [Docket No. FDA–2012–N–0369]
                                                         and Lipoproteins. A Meta-Analysis of 27                 Fat, Saturated Fat, and Cholesterol,’’
                                                         Trials,’’ Arteriosclerosis, Thrombosis,                 Nutrition Reviews, 69:270–278, 2011.              Agency Information Collection
                                                         and Vascular Biology, 12:911–919, 1992.            57. Willett W. C., ‘‘Dietary Fats and Coronary         Activities; Submission for Office of
                                                    43. Reeves, R. M., ‘‘Effect of Dietary Trans                 Heart Disease,’’ Journal of Internal
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                                                         [Letter to the editor], New England                58. National Heart, Lung, and Blood Institute,         Comment Request; Regulations Under
                                                         Journal of Medicine, 324:338–339, 1991.                 ‘‘Lifestyle Interventions to Reduce               the Federal Import Milk Act
                                                    44. Katan M. B., P. L. Zock, R. P. Mensink,                  Cardiovascular Risk: Systematic
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                                                                                                                                                                   AGENCY:   Food and Drug Administration,
                                                         ‘‘Trans Fatty Acids and their Effects on                Evidence Review From the Lifestyle
                                                                                                                                                                   HHS.
                                                         Lipoproteins in Humans,’’ Annual                        Work Group,’’ Bethesda, MD: HHS,
                                                         Review of Nutrition, 15:473–493, 1995.                  National Institutes of Health, 2013               ACTION:   Notice.
                                                    45. Zock P. L. and R. P. Mensink, ‘‘Dietary                  (http://www.nhlbi.nih.gov/health-pro/
                                                         Trans-Fatty Acids and Serum                             guidelines/in-develop/cardiovascular-             SUMMARY:   The Food and Drug
                                                         Lipoproteins in Humans,’’ Current                       risk-reduction/lifestyle).                        Administration (FDA) is announcing
                                                         Opinion in Lipidology, 7:34–37, 1996.              59. Burlingame B., C. Nishida, R. Uauy, et al.,        that a proposed collection of
                                                    46. Oh, K., F. B. Hu, J. E. Manson, et al.,                  ‘‘Fats and Fatty Acids in Human                   information has been submitted to the
                                                         ‘‘Dietary Fat Intake and Risk of Coronary               Nutrition: Introduction,’’ Annals of              Office of Management and Budget


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                                                                                          Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                                                                                    34671

                                                    (OMB) for review and clearance under                                          collection of information to OMB for                                         and plants producing milk and/or cream
                                                    the Paperwork Reduction Act of 1995.                                          review and clearance.                                                        to be shipped to the United States.
                                                    DATES: Fax written comments on the                                               Under Federal Import Milk Act                                             Section 1210.12 requires reports on the
                                                    collection of information by July 17,                                         (FIMA) (21 U.S.C. 141–149), milk or                                          physical examination of herds, while
                                                    2015.                                                                         cream may be imported into the United                                        § 1210.13 requires the reporting of
                                                                                                                                  States only by the holder of a valid                                         tuberculin testing of the herds. In
                                                    ADDRESSES: To ensure that comments on
                                                                                                                                  import milk permit (21 U.S.C. 141).                                          addition, the regulations in part 1210
                                                    the information collection are received,
                                                                                                                                  Before such permit is issued: (1) All                                        require that dairy farmers and plants
                                                    OMB recommends that written
                                                                                                                                  cows from which import milk or cream                                         maintain pasteurization records
                                                    comments be faxed to the Office of
                                                                                                                                  is produced must be physically                                               (§ 1210.15) and that each container of
                                                    Information and Regulatory Affairs,
                                                                                                                                  examined and found healthy; (2) if the                                       milk or cream imported into the United
                                                    OMB, Attn: FDA Desk Officer, FAX:
                                                                                                                                  milk or cream is imported raw, all such                                      States bear a tag with the product type,
                                                    202–395–7285, or emailed to oira_
                                                                                                                                  cows must pass a tuberculin test; (3) the                                    permit number, and shipper’s name and
                                                    submission@omb.eop.gov. All
                                                                                                                                  dairy farm and each plant in which the                                       address (§ 1210.22). Section 1210.20
                                                    comments should be identified with the
                                                                                                                                  milk or cream is processed or handled                                        requires that an application for a permit
                                                    OMB control number 0910–0212. Also
                                                                                                                                  must be inspected and found to meet                                          to ship or transport milk or cream into
                                                    include the FDA docket number found
                                                                                                                                  certain sanitary requirements; (4)                                           the United States be made by the actual
                                                    in brackets in the heading of this
                                                                                                                                  bacterial counts of the milk at the time                                     shipper. Section 1210.23 allows permits
                                                    document.
                                                                                                                                  of importation must not exceed                                               to be granted based on certificates from
                                                    FOR FURTHER INFORMATION CONTACT: FDA                                          specified limits; and (5) the temperature                                    accredited officials.
                                                    PRA Staff, Office of Operations, Food                                         of the milk or cream at time of                                                 In the Federal Register of March 25,
                                                    and Drug Administration, 8455                                                 importation must not exceed 50 °F (21                                        2015 (80 FR 15794), FDA published a
                                                    Colesville Road; COLE–14526, Silver                                           U.S.C. 142).                                                                 60-day notice requesting public
                                                    Spring, MD 20993–0002 PRAStaff@                                                  Our regulations in part 1210 (21 CFR                                      comment on the proposed collection of
                                                    fda.hhs.gov.                                                                  part 1210) implement the provisions of                                       information. No comments were
                                                    SUPPLEMENTARY INFORMATION: In                                                 FIMA. Sections 1210.11 and 1210.14                                           received in response to the notice.
                                                    compliance with 44 U.S.C. 3507, FDA                                           require reports on the sanitary                                                 We estimate the burden of this
                                                    has submitted the following proposed                                          conditions of, respectively, dairy farms                                     collection of information as follows:

                                                                                                                   TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                Number of
                                                        21 CFR                                                                       Number of                                             Total annual                  Average burden per
                                                                                             Form No.                                                         responses per                                                                                       Total hours
                                                        Section                                                                     respondents                                             responses                         response
                                                                                                                                                                respondent

                                                    1210.11 ........       FDA 1996; Sanitary Inspection                                                2                      200                          400      1.5 ...................................               600
                                                                             of Dairy Farms.
                                                    1210.12 ........       FDA 1995; Physical Examina-                                                   1                         1                           1     0.5 (30 minutes) .............                            0.5
                                                                             tion of Cows.
                                                    1210.13 ........       FDA 1994; Tuberculin Test ......                                             1                          1                           1     0.5 (30 minutes) .............                            0.5
                                                    1210.14 ........       FDA 1997; Sanitary Inspections                                               2                          1                           2     2 ......................................                    4
                                                                             of Plants.
                                                    1210.20 ........       FDA 1993; Application for Per-                                                2                         1                           2     0.5 (30 minutes) .............                             1
                                                                             mit.
                                                    1210.23 ........       FDA 1815; Permits Granted on                                                  2                         1                           2     0.5 (30 minutes) .............                             1
                                                                             Certificates.

                                                          Total ......      ...................................................    ........................   ........................    ........................   .........................................             607
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.

                                                                                                              TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
                                                                                                                                                                   Number of
                                                                                                                                    Number of                                                     Total annual                Average burden
                                                                          21 CFR Section                                                                         responses per                                                                                   Total hours
                                                                                                                                   respondents                                                     responses                   per response
                                                                                                                                                                   respondent

                                                    1210.15 ............................................................                    2                              1                               2                            0.05                        0.1
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                      The estimated number of respondents                                         response, for a total burden of 607                                          Because we have not received any
                                                    and hours per response are based on our                                       hours.                                                                       Forms FDA 1994 and 1995 in the last 3
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    experience with the import milk permit                                          The Secretary of Health and Human                                          years, the Agency estimates no more
                                                    program and the average number of                                             Services has the discretion to allow                                         than one will be submitted annually.
                                                    import milk permit holders over the                                           Form FDA 1815, a duly certified                                              We estimate the reporting burden for
                                                    past three years. We estimate that two                                        statement signed by an accredited                                            each to be 0.5 hours per response for a
                                                    respondents will submit approximately                                         official of a foreign government, to be                                      total burden reporting burden of 0.5
                                                    200 Form FDA 1996 reports annually,                                           submitted in lieu of Forms FDA 1994                                          hours each.
                                                    for a total of 600 responses. We estimate                                     and 1995. To date, Form FDA 1815 has                                           We estimate that two respondents will
                                                    the reporting burden to be 1.5 hours per                                      been submitted in lieu of these forms.                                       submit one Form FDA 1997 report


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                                                    34672                        Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

                                                    annually, for a total of two responses.                 SUMMARY:   The Food and Drug                           DATES:   Fax written comments on the
                                                    We estimate the reporting burden to be                  Administration (FDA) is announcing                     collection of information by July 17,
                                                    2 hours per response, for a total burden                that a collection of information entitled,             2015.
                                                    of 4 hours. We estimate that two                        ‘‘Food and Cosmetic Export Certificate                 ADDRESSES: To ensure that comments on
                                                    respondents will submit one Form FDA                    Applications Process’’ has been                        the information collection are received,
                                                    1993 report annually, for a total of two                approved by the Office of Management                   OMB recommends that written
                                                    responses. We estimate the reporting                    and Budget (OMB) under the Paperwork                   comments be faxed to the Office of
                                                    burden to be 0.5 hours per response, for                Reduction Act of 1995.                                 Information and Regulatory Affairs,
                                                    a total burden of 1 hour. We estimate                   FOR FURTHER INFORMATION CONTACT: FDA                   OMB, Attn: FDA Desk Officer, FAX:
                                                    that two respondents will submit one                    PRA Staff, Office of Operations, Food                  202–395–7285, or emailed to oira_
                                                    Form FDA 1815 report annually, for a                    and Drug Administration, 8455                          submission@omb.eop.gov. All
                                                    total of two responses. We estimate the                 Colesville Rd., COLE–14526, Silver                     comments should be identified with the
                                                    reporting burden to be 0.5 hours per                    Spring, MD 20993–0002,                                 OMB control number 0910-New and
                                                    response, for a total burden of 1 hour.                 PRAStaff@fda.hhs.gov.                                  title ‘‘Impact of Ad Exposure Frequency
                                                       With regard to records maintenance,                                                                         on Perception and Mental Processing of
                                                    we estimate that approximately two                      SUPPLEMENTARY INFORMATION:     On April                Risk and Benefit Information in Direct-
                                                    recordkeepers will spend 0.05 hours                     23, 2015, the Agency submitted a                       To-Consumer Prescription Drug Ads.’’
                                                    annually maintaining the additional                     proposed collection of information                     Also include the FDA docket number
                                                    pasteurization records required by                      entitled, ‘‘Food and Cosmetic Export                   found in brackets in the heading of this
                                                    § 1210.15, for a total of 0.10 hours                    Certificate Applications Process’’ to                  document.
                                                    annually.                                               OMB for review and clearance under 44                  FOR FURTHER INFORMATION CONTACT: FDA
                                                       No burden has been estimated for the                 U.S.C. 3507. An Agency may not                         PRA Staff, Office of Operations, Food
                                                    tagging requirement in § 1210.22                        conduct or sponsor, and a person is not                and Drug Administration, 8455
                                                    because the information on the tag is                   required to respond to, a collection of                Colesville Rd., COLE–14526, Silver
                                                    either supplied by us (permit number)                   information unless it displays a                       Spring, MD 20993–0002, PRAStaff@
                                                    or is disclosed to third parties as a usual             currently valid OMB control number.                    fda.hhs.gov.
                                                    and customary part of the shipper’s                     OMB has now approved the information
                                                                                                            collection and has assigned OMB                        SUPPLEMENTARY INFORMATION: In
                                                    normal business activities (type of
                                                                                                            control number 0910–0793. The                          compliance with 44 U.S.C. 3507, FDA
                                                    product, shipper’s name and address).
                                                                                                            approval expires on May 31, 2018. A                    has submitted the following proposed
                                                    Under 5 CFR 1320.3(c)(2), the public
                                                                                                            copy of the supporting statement for this              collection of information to OMB for
                                                    disclosure of information originally
                                                                                                            information collection is available on                 review and clearance.
                                                    supplied by the Federal Government to
                                                    the recipient for the purpose of                        the Internet at http://www.reginfo.gov/                Impact of Ad Exposure Frequency on
                                                    disclosure to the public is not subject to              public/do/PRAMain.                                     Perception and Mental Processing of
                                                    review by the Office of Management and                    Dated: June 11, 2015.                                Risk and Benefit Information in Direct-
                                                    Budget under the Paperwork Reduction                    Leslie Kux,                                            to-Consumer Prescription Drug Ads;
                                                    Act. Under 5 CFR 1320.3(b)(2)), the                     Associate Commissioner for Policy.
                                                                                                                                                                   OMB Control Number 0910–NEW
                                                    time, effort, and financial resources                                                                             Section 1701(a)(4) of the Public
                                                                                                            [FR Doc. 2015–14879 Filed 6–16–15; 8:45 am]
                                                    necessary to comply with a collection of                                                                       Health Service Act (42 U.S.C.
                                                                                                            BILLING CODE 4164–01–P
                                                    information are excluded from the                                                                              300u(a)(4)) authorizes the FDA to
                                                    burden estimate if the reporting,                                                                              conduct research relating to health
                                                    recordkeeping, or disclosure activities                 DEPARTMENT OF HEALTH AND                               information. Section 1003(d)(2)(C) of the
                                                    needed to comply are usual and                          HUMAN SERVICES                                         Federal Food, Drug, and Cosmetic Act
                                                    customary because they would occur in                                                                          (the FD&C Act) (21 U.S.C. 393(b)(2)(c))
                                                    the normal course of business activities.               Food and Drug Administration                           authorizes FDA to conduct research
                                                      Dated: June 11, 2015.                                                                                        relating to drugs and other FDA-
                                                    Leslie Kux,                                             [Docket No. FDA–2014–N–1794]                           regulated products in carrying out the
                                                    Associate Commissioner for Policy.                                                                             provisions of the FD&C Act.
                                                    [FR Doc. 2015–14888 Filed 6–16–15; 8:45 am]             Agency Information Collection                             In a typical promotional campaign,
                                                                                                            Activities; Submission for Office of                   consumers may be exposed to a direct-
                                                    BILLING CODE 4164–01–P
                                                                                                            Management and Budget Review;                          to-consumer (DTC) prescription drug ad
                                                                                                            Comment Request; Impact of Ad                          any number of times. Perceptual and
                                                    DEPARTMENT OF HEALTH AND                                Exposure Frequency on Perception                       cognitive effects of increased ad
                                                    HUMAN SERVICES                                          and Mental Processing of Risk and                      exposure frequency have been studied
                                                                                                            Benefit Information in Direct-to-                      extensively using non-drug ads. For
                                                    Food and Drug Administration                            Consumer Prescription Drug Ads                         instance, one study demonstrated that a
                                                                                                                                                                   commercial message repeated twice
                                                    [Docket No. FDA–2014–N–2347]                            AGENCY:    Food and Drug Administration,               generates better recall than a message
                                                                                                            HHS.                                                   broadcast only once (Ref. 1). Another
                                                    Agency Information Collection                                                                                  study demonstrated that increased ad
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                            ACTION:   Notice.
                                                    Activities; Announcement of Office of                                                                          exposures improve product attitudes
                                                    Management and Budget Approval;                         SUMMARY:   The Food and Drug                           and recall for product attributes,
                                                    Food and Cosmetic Export Certificate                    Administration (FDA) is announcing                     particularly when the substance of the
                                                    Applications Process                                    that a proposed collection of                          repeat messages is varied (Ref. 2).
                                                    AGENCY:    Food and Drug Administration,                information has been submitted to the                  Generally, it has been argued that first
                                                    HHS.                                                    Office of Management and Budget                        exposure to an ad results in attention,
                                                                                                            (OMB) for review and clearance under                   second exposure affects learning of the
                                                    ACTION:   Notice.
                                                                                                            the Paperwork Reduction Act of 1995.                   advertised message, and third and


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Document Created: 2015-12-15 14:23:10
Document Modified: 2015-12-15 14:23:10
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 July 17, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver Spring, MD 20993-0002 [email protected]
FR Citation80 FR 34670 

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