81_FR_3447 81 FR 3434 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program

81 FR 3434 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

Page Range3434-3435
FR Document2016-01102

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 81 Issue 13 (Thursday, January 21, 2016)
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3434-3435]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01102]



[[Page 3434]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Contact 
Substance Notification Program

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 
February 22, 2016.

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 0910-0495. 
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 Rd., 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.

Food Contact Substance Notification Program;--21 CFR 170.101, 170.106, 
and 171.1 OMB Control Number 0910-0495--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification 
process for food contact substances. Section 409(h)(6) of the FD&C Act 
defines a ``food contact substance'' as ``any substance intended for 
use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.'' Section 409(h)(3) of the FD&C 
Act requires that the notification process be used for authorizing the 
marketing of food contact substances except when: (1) We determine that 
the submission and premarket review of a food additive petition (FAP) 
under section 409(b) of the FD&C Act is necessary to provide adequate 
assurance of safety or (2) we and the manufacturer or supplier agree 
that an FAP should be submitted. Section 409(h)(1) of the FD&C Act 
requires that a notification include: (1) Information on the identity 
and the intended use of the food contact substance and (2) the basis 
for the manufacturer's or supplier's determination that the food 
contact substance is safe under the intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101 
and 170.106) specify the information that a notification must contain 
and require that: (1) A food contact substance notification (FCN) 
includes Form FDA 3480 and (2) a notification for a food contact 
substance formulation includes Form FDA 3479. These forms serve to 
summarize pertinent information in the notification. The forms 
facilitate both preparation and review of notifications because the 
forms will serve to organize information necessary to support the 
safety of the use of the food contact substance. The burden of filling 
out the appropriate form has been included in the burden estimate for 
the notification.
    Currently, interested persons transmit an FCN submission to the 
Office of Food Additive Safety in the Center for Food Safety and 
Applied Nutrition using Form FDA 3480 whether it is submitted in 
electronic or paper format. We estimate that the amount of time for 
respondents to complete Form FDA 3480 will continue to be the same.
    In addition to its required use with FCNs, Form FDA 3480 is 
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN 
according to the items listed on the form. Master Files can be used as 
repositories for information that can be referenced in multiple 
submissions to FDA, thus minimizing paperwork burden for food contact 
substance authorizations. We estimate that the amount of time for 
respondents to complete the Form FDA 3480 for these types of 
submissions is 0.5 hours.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the 
information that a petitioner must submit in order to: (1) Establish 
that the proposed use of an indirect food additive is safe and (2) 
secure the publication of an indirect food additive regulation in parts 
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178 
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled, ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations,'' provides 
assistance to manufacturers of food packaging in evaluating processes 
for producing packaging from post-consumer recycled plastic. The 
recommendations in the guidance address the process by which 
manufacturers certify to us that their plastic products are safe for 
food contact.
    Description of Respondents: The respondents to this information 
collection are manufacturers of food contact substances.
    In the Federal Register of October 8, 2015 (80 FR 60911), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Number of
      21 CFR Section or other category              FDA Form No.            Number of     responses per   Total annual   Average  burden    Total hours
                                                                           respondents     respondent       responses     per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A)...................  FDA 3479..................              10               2              20              2                40
170.101 \3\ \7\ (Category B)...............  FDA 3480..................               6               1               6             25               150
170.101 \4\ \7\ (Category C)...............  FDA 3480..................               6               2              12            120             1,440
170.101 \5\ \7\ (Category D)...............  FDA 3480..................              42               2              84            150            12,600
170.101 \6\ \7\ (Category E)...............  FDA 3480..................              38               1              38            150             5,700

[[Page 3435]]

 
Pre-notification Consultation or Master      FDA 3480..................             190               1             190              0.5              95
 File (concerning a food contact
 substance).\8\
Amendment to an existing notification        FDA 3480A.................             100               1             100              0.5              50
 (170.101), amendment to a Pre-notification
 Consultation, or amendment to a Master
 File (concerning a food contact
 substance).\9\
171.1 Indirect Food Additive Petitions.....  N/A.......................               1               1               1         10,995            10,995
Use of Recycled Plastics in Food Packaging:  N/A.......................              10               1              10             25               250
 Chemistry Considerations.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total..................................  ..........................  ..............  ..............  ..............  ...............          31,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
  (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of Form FDA 3480.
\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.

    The estimates in table 1 are based on our current experience with 
the food contact substance notification program and informal 
communication with industry.
    Beginning in row 1 we estimate 10 respondents will submit two 
notifications annually for food contact substance formulations (Form 
FDA 3479), for a total of 20 responses. We calculate a reporting burden 
of 2 hours per response, for a total of 40 hours. In row 2 we estimate 
six respondents. We believe the hourly burden for preparing these 
notifications will primarily consist of the manufacturer or supplier 
completing Form FDA 3480, verifying that a previous notification is 
effective and preparing necessary documentation. We estimate one 
submission for each respondent, for a total of six responses. We 
calculate a reporting burden of 25 hours per response, for a total of 
150 hours.
    In rows 3, 4, and 5 we identify three tiers of FCNs that reflect 
different levels of burden applicable to the respective information 
collection items (denoted as Categories C, D, and E). We estimate 6 
respondents will submit 2 Category C submissions annually, for a total 
of 12 responses. We calculate a reporting burden of 120 hours per 
response, for a total burden of 1,440 hours. We estimate 42 respondents 
will submit 2 Category D submissions annually, for a total of 84 
responses. We calculate a reporting burden of 150 hours per response, 
for a total burden of 12,600 hours. We estimate 38 respondents will 
submit 1Category E submission annually, for a total of 38 responses. We 
calculate a reporting burden of 150 hours per response, for a total 
burden of 5,700 hours.
    In row 6 we estimate 190 respondents will submit information to a 
pre-notification consultation or a master file in support of FCN 
submission using Form FDA 3480. We calculate a reporting burden of 0.5 
hours per response, for a total burden of 95 hours. In row 7 we 
estimate 100 respondents will submit an amendment (Form FDA 3480A) to a 
substantive or non-substantive request of additional information to an 
incomplete FCN submission, an amendment to a pre-notification 
consultation, or an amendment to a master file in support of an FCN. We 
calculate a reporting burden of 0.5 hours per response, for a total 
burden of 50 hours.
    In row 8 we estimate one respondent will submit one indirect food 
additive petition under Sec.  171.1, for a total of one response. We 
calculate a reporting burden of 10,995 hours per response, for a total 
burden of 10,995 hours.
    Finally, in row 9 we estimate ten respondents will utilize the 
recommendations in the guidance document entitled, ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations,'' to develop the 
additional information for one such submission annually, for a total of 
10 responses. We calculate a reporting burden of 25 hours per response, 
for a total burden of 250 hours.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01102 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                    3434                            Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices

                                                    DEPARTMENT OF HEALTH AND                                     (21 U.S.C. 348(h)) establishes a                         In addition to its required use with
                                                    HUMAN SERVICES                                               premarket notification process for food                FCNs, Form FDA 3480 is recommended
                                                                                                                 contact substances. Section 409(h)(6) of               to be used to organize information
                                                    Food and Drug Administration                                 the FD&C Act defines a ‘‘food contact                  within a Pre-notification Consultation or
                                                    [Docket No. FDA–2012–N–0294]                                 substance’’ as ‘‘any substance intended                Master File submitted in support of an
                                                                                                                 for use as a component of materials used               FCN according to the items listed on the
                                                    Agency Information Collection                                in manufacturing, packing, packaging,                  form. Master Files can be used as
                                                    Activities; Submission for Office of                         transporting, or holding food if such use              repositories for information that can be
                                                    Management and Budget Review;                                is not intended to have any technical                  referenced in multiple submissions to
                                                    Comment Request; Food Contact                                effect in such food.’’ Section 409(h)(3) of            FDA, thus minimizing paperwork
                                                    Substance Notification Program                               the FD&C Act requires that the
                                                                                                                                                                        burden for food contact substance
                                                                                                                 notification process be used for
                                                    AGENCY:     Food and Drug Administration,                    authorizing the marketing of food                      authorizations. We estimate that the
                                                    HHS.                                                         contact substances except when: (1) We                 amount of time for respondents to
                                                    ACTION:    Notice.                                           determine that the submission and                      complete the Form FDA 3480 for these
                                                                                                                 premarket review of a food additive                    types of submissions is 0.5 hours.
                                                    SUMMARY:   The Food and Drug
                                                                                                                 petition (FAP) under section 409(b) of                   Section 171.1 of FDA’s regulations (21
                                                    Administration (FDA) is announcing
                                                                                                                 the FD&C Act is necessary to provide                   CFR 171.1) specifies the information
                                                    that a proposed collection of
                                                                                                                 adequate assurance of safety or (2) we                 that a petitioner must submit in order
                                                    information has been submitted to the
                                                    Office of Management and Budget                              and the manufacturer or supplier agree                 to: (1) Establish that the proposed use of
                                                    (OMB) for review and clearance under                         that an FAP should be submitted.                       an indirect food additive is safe and (2)
                                                    the Paperwork Reduction Act of 1995.                         Section 409(h)(1) of the FD&C Act                      secure the publication of an indirect
                                                                                                                 requires that a notification include: (1)              food additive regulation in parts 175
                                                    DATES: Fax written comments on the
                                                                                                                 Information on the identity and the                    through 178 (21 CFR parts 175 through
                                                    collection of information by February
                                                                                                                 intended use of the food contact                       178). Parts 175 through 178 describe the
                                                    22, 2016.
                                                                                                                 substance and (2) the basis for the                    conditions under which the additive
                                                    ADDRESSES: To ensure that comments on                        manufacturer’s or supplier’s
                                                    the information collection are received,                                                                            may be safely used.
                                                                                                                 determination that the food contact
                                                    OMB recommends that written                                  substance is safe under the intended                     In addition, FDA’s guidance
                                                    comments be faxed to the Office of                           conditions of use.                                     document entitled, ‘‘Use of Recycled
                                                    Information and Regulatory Affairs,                             Sections 170.101 and 170.106 of                     Plastics in Food Packaging: Chemistry
                                                    OMB, Attn: FDA Desk Officer, FAX:                            FDA’s regulations (21 CFR 170.101 and                  Considerations,’’ provides assistance to
                                                    202–395–7285, or emailed to oira_                            170.106) specify the information that a                manufacturers of food packaging in
                                                    submission@omb.eop.gov. All                                  notification must contain and require                  evaluating processes for producing
                                                    comments should be identified with the                       that: (1) A food contact substance                     packaging from post-consumer recycled
                                                    OMB control number 0910–0495. Also                           notification (FCN) includes Form FDA                   plastic. The recommendations in the
                                                    include the FDA docket number found                          3480 and (2) a notification for a food
                                                    in brackets in the heading of this                                                                                  guidance address the process by which
                                                                                                                 contact substance formulation includes                 manufacturers certify to us that their
                                                    document.                                                    Form FDA 3479. These forms serve to                    plastic products are safe for food
                                                    FOR FURTHER INFORMATION CONTACT: FDA                         summarize pertinent information in the                 contact.
                                                    PRA Staff, Office of Operations, Food                        notification. The forms facilitate both
                                                    and Drug Administration, 8455                                preparation and review of notifications                  Description of Respondents: The
                                                    Colesville Rd., COLE–14526, Silver                           because the forms will serve to organize               respondents to this information
                                                    Spring, MD 20993–0002, PRAStaff@                             information necessary to support the                   collection are manufacturers of food
                                                    fda.hhs.gov.                                                 safety of the use of the food contact                  contact substances.
                                                    SUPPLEMENTARY INFORMATION: In                                substance. The burden of filling out the                 In the Federal Register of October 8,
                                                    compliance with 44 U.S.C. 3507, FDA                          appropriate form has been included in                  2015 (80 FR 60911), FDA published a
                                                    has submitted the following proposed                         the burden estimate for the notification.              60-day notice requesting public
                                                    collection of information to OMB for                            Currently, interested persons transmit              comment on the proposed collection of
                                                    review and clearance.                                        an FCN submission to the Office of Food                information. No comments were
                                                                                                                 Additive Safety in the Center for Food                 received.
                                                    Food Contact Substance Notification                          Safety and Applied Nutrition using
                                                    Program;—21 CFR 170.101, 170.106,                            Form FDA 3480 whether it is submitted                    We estimate the burden of this
                                                    and 171.1 OMB Control Number 0910–                           in electronic or paper format. We                      collection of information as follows:
                                                    0495—Extension                                               estimate that the amount of time for
                                                      Section 409(h) of the Federal Food,                        respondents to complete Form FDA
                                                    Drug, and Cosmetic Act (the FD&C Act)                        3480 will continue to be the same.

                                                                                                        TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSK9F6TC42PROD with NOTICES




                                                                                                                                                    Number of                              Average
                                                                                                                  FDA         Number of                              Total annual
                                                           21 CFR Section or other category                                                       responses per                          burden per   Total hours
                                                                                                                Form No.     respondents                              responses
                                                                                                                                                    respondent                            response

                                                    170.106 2 (Category A) ..................................   FDA   3479                   10                 2                20               2             40
                                                    170.101 3 7 (Category B) ................................   FDA   3480                    6                 1                 6              25            150
                                                    170.101 4 7 (Category C) ................................   FDA   3480                    6                 2                12             120          1,440
                                                    170.101 5 7 (Category D) ................................   FDA   3480                   42                 2                84             150         12,600
                                                    170.101 6 7 (Category E) ................................   FDA   3480                   38                 1                38             150          5,700



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                                                                                         Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices                                                                                               3435

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

                                                    Pre-notification Consultation or Master File                          FDA 3480                             190                            1                     190                            0.5               95
                                                      (concerning a food contact substance).8
                                                    Amendment to an existing notification                                 FDA                                 100                             1                      100                           0.5               50
                                                      (170.101), amendment to a Pre-notifica-                               3480A.
                                                      tion Consultation, or amendment to a
                                                      Master File (concerning a food contact
                                                      substance).9
                                                    171.1 Indirect Food Additive Petitions ........                       N/A .........                          1                           1                         1                  10,995                 10,995
                                                    Use of Recycled Plastics in Food Packaging:                           N/A .........                         10                           1                        10                      25                    250
                                                      Chemistry Considerations.

                                                         Total ........................................................   ................   ........................   ........................   ........................   ..........................         31,320
                                                       1 There   are no capital costs or operating and maintenance costs associated with this collection of information.
                                                       2 Notifications  for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
                                                    (‘‘Notification for a Food Contact Substance Formulation’’) only.
                                                       3 Duplicate notifications for uses of food contact substances.
                                                       4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
                                                       5 Notifications for uses that are the subject of moderately complex food additive petitions.
                                                       6 Notifications for uses that are the subject of very complex food additive petitions.
                                                       7 These notifications require the submission of Form FDA 3480.
                                                       8 These notifications recommend the submission of Form FDA 3480.
                                                       9 These notifications recommend the submission of Form FDA 3480A.




                                                       The estimates in table 1 are based on                                reporting burden of 150 hours per                                              Dated: January 14, 2016.
                                                    our current experience with the food                                    response, for a total burden of 5,700                                        Leslie Kux,
                                                    contact substance notification program                                  hours.                                                                       Associate Commissioner for Policy.
                                                    and informal communication with                                            In row 6 we estimate 190 respondents                                      [FR Doc. 2016–01102 Filed 1–20–16; 8:45 am]
                                                    industry.
                                                       Beginning in row 1 we estimate 10                                    will submit information to a pre-                                            BILLING CODE 4164–01–P

                                                    respondents will submit two                                             notification consultation or a master file
                                                    notifications annually for food contact                                 in support of FCN submission using
                                                                                                                                                                                                         DEPARTMENT OF HEALTH AND
                                                    substance formulations (Form FDA                                        Form FDA 3480. We calculate a
                                                                                                                                                                                                         HUMAN SERVICES
                                                    3479), for a total of 20 responses. We                                  reporting burden of 0.5 hours per
                                                    calculate a reporting burden of 2 hours                                 response, for a total burden of 95 hours.                                    Food and Drug Administration
                                                    per response, for a total of 40 hours. In                               In row 7 we estimate 100 respondents
                                                                                                                                                                                                         [Docket No. FDA–2015–P–3319]
                                                    row 2 we estimate six respondents. We                                   will submit an amendment (Form FDA
                                                    believe the hourly burden for preparing                                 3480A) to a substantive or non-                                              Determination That MEVACOR
                                                    these notifications will primarily consist                              substantive request of additional                                            (Lovastatin) Tablets, 20 Milligrams and
                                                    of the manufacturer or supplier                                         information to an incomplete FCN                                             40 Milligrams, Were Not Withdrawn
                                                    completing Form FDA 3480, verifying                                     submission, an amendment to a pre-                                           From Sale for Reasons of Safety or
                                                    that a previous notification is effective                               notification consultation, or an                                             Effectiveness
                                                    and preparing necessary documentation.                                  amendment to a master file in support
                                                    We estimate one submission for each                                                                                                                  AGENCY:         Food and Drug Administration,
                                                                                                                            of an FCN. We calculate a reporting
                                                    respondent, for a total of six responses.                                                                                                            HHS.
                                                                                                                            burden of 0.5 hours per response, for a
                                                    We calculate a reporting burden of 25                                   total burden of 50 hours.                                                    ACTION:        Notice.
                                                    hours per response, for a total of 150
                                                    hours.                                                                     In row 8 we estimate one respondent                                       SUMMARY:   The Food and Drug
                                                       In rows 3, 4, and 5 we identify three                                will submit one indirect food additive                                       Administration (FDA or Agency) has
                                                    tiers of FCNs that reflect different levels                             petition under § 171.1, for a total of one                                   determined that MEVACOR (lovastatin)
                                                    of burden applicable to the respective                                  response. We calculate a reporting                                           tablets, 20 milligrams (mg) and 40 mg,
                                                    information collection items (denoted as                                burden of 10,995 hours per response, for                                     were not withdrawn from sale for
                                                    Categories C, D, and E). We estimate 6                                  a total burden of 10,995 hours.                                              reasons of safety or effectiveness. This
                                                    respondents will submit 2 Category C                                                                                                                 determination means that FDA will not
                                                                                                                               Finally, in row 9 we estimate ten                                         begin procedures to withdraw approval
                                                    submissions annually, for a total of 12                                 respondents will utilize the
                                                    responses. We calculate a reporting                                                                                                                  of abbreviated new drug applications
                                                                                                                            recommendations in the guidance                                              (ANDAs) that refer to these drug
                                                    burden of 120 hours per response, for a                                 document entitled, ‘‘Use of Recycled
                                                    total burden of 1,440 hours. We estimate                                                                                                             products, and it will allow FDA to
asabaliauskas on DSK9F6TC42PROD with NOTICES




                                                                                                                            Plastics in Food Packaging: Chemistry                                        continue to approve ANDAs that refer to
                                                    42 respondents will submit 2 Category
                                                                                                                            Considerations,’’ to develop the                                             the products as long as they meet
                                                    D submissions annually, for a total of 84
                                                    responses. We calculate a reporting                                     additional information for one such                                          relevant legal and regulatory
                                                    burden of 150 hours per response, for a                                 submission annually, for a total of 10                                       requirements.
                                                    total burden of 12,600 hours. We                                        responses. We calculate a reporting                                          FOR FURTHER INFORMATION CONTACT: Kate
                                                    estimate 38 respondents will submit                                     burden of 25 hours per response, for a                                       Greenwood, Center for Drug Evaluation
                                                    1Category E submission annually, for a                                  total burden of 250 hours.                                                   and Research, Food and Drug
                                                    total of 38 responses. We calculate a                                                                                                                Administration, 10903 New Hampshire


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Document Created: 2018-02-02 12:33:36
Document Modified: 2018-02-02 12:33:36
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 February 22, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 3434 

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