82_FR_26605 82 FR 26497 - Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys

82 FR 26497 - Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 108 (June 7, 2017)

Page Range26497-26498
FR Document2017-11822

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on voluntary customer satisfaction service surveys to implement Executive Order 12862.

Federal Register, Volume 82 Issue 108 (Wednesday, June 7, 2017)
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26497-26498]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11822]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0019]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Customer/Partner Service Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on voluntary customer satisfaction service 
surveys to implement Executive Order 12862.

DATES: Submit either electronic or written comments on the collection 
of information by August 7, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 7, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0019 for ``Customer/Partner Service Surveys.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information,

[[Page 26498]]

including each proposed extension of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Customer/Partner Service Surveys; OMB Control Number 0910-0360--
Extension

    Under section 903 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 393), FDA is authorized to conduct research and public 
information programs about regulated products and responsibilities of 
the Agency. Executive Order 12862, entitled, ``Setting Customer Service 
Standard,'' directs Federal Agencies that ``provide significant 
services directly to the public'' to ``survey customers to determine 
the kind and quality of services they want and their level of 
satisfaction with existing services.'' FDA is seeking OMB clearance to 
conduct a series of surveys to implement Executive Order 12862. 
Participation in the surveys is voluntary. This request covers 
customer/partner service surveys of regulated entities, such as food 
processors; cosmetic drug, biologic and medical device manufacturers; 
consumers; and health professionals. The request also covers 
``partner'' (State and local governments) customer service surveys.
    FDA will use the information from these surveys to identify 
strengths and weaknesses in service to customers/partners and to make 
improvements. The surveys will measure timeliness, appropriateness and 
accuracy of information, courtesy and problem resolution in the context 
of individual programs.
    FDA estimates conducting 15 customer/partner service surveys per 
year, each requiring an average of 15 minutes for review and 
completion. We estimate respondents to these surveys to be between 100 
and 20,000 customers. Some of these surveys will be repeats of earlier 
surveys for purposes of monitoring customer/partner service and 
developing long-term data.
    FDA estimates the burden of this collection of information as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                            Annual
            Type of survey                 Number of     frequency per     Hours per response       Total hours
                                          respondents      response
----------------------------------------------------------------------------------------------------------------
Mail, telephone, web-based............          55,000               1  0.25 (15 minutes).......          13,750
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11822 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P



                                                                              Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices                                          26497

                                                due to a disability, please contact                     considered timely if they are                          comments only as a written/paper
                                                Jennifer Shepherd at least 7 days in                    postmarked or the delivery service                     submission. You should submit two
                                                advance of the meeting.                                 acceptance receipt is on or before that                copies total. One copy will include the
                                                  FDA is committed to the orderly                       date.                                                  information you claim to be confidential
                                                conduct of its advisory committee                                                                              with a heading or cover note that states
                                                                                                        Electronic Submissions
                                                meetings. Please visit our Web site at                                                                         ‘‘THIS DOCUMENT CONTAINS
                                                https://www.fda.gov/Advisory                              Submit electronic comments in the                    CONFIDENTIAL INFORMATION.’’ The
                                                Committees/AboutAdvisoryCommittees/                     following way:                                         Agency will review this copy, including
                                                ucm111462.htm for procedures on                           • Federal eRulemaking Portal:                        the claimed confidential information, in
                                                public conduct during advisory                          https://www.regulations.gov. Follow the                its consideration of comments. The
                                                committee meetings.                                     instructions for submitting comments.                  second copy, which will have the
                                                  Notice of this meeting is given under                 Comments submitted electronically,                     claimed confidential information
                                                the Federal Advisory Committee Act (5                   including attachments, to https://                     redacted/blacked out, will be available
                                                U.S.C. app. 2).                                         www.regulations.gov will be posted to                  for public viewing and posted on
                                                                                                        the docket unchanged. Because your                     https://www.regulations.gov. Submit
                                                  Dated: June 1, 2017.
                                                                                                        comment will be made public, you are                   both copies to the Division of Dockets
                                                Anna K. Abram,                                          solely responsible for ensuring that your
                                                Deputy Commissioner for Policy, Planning,
                                                                                                                                                               Management. If you do not wish your
                                                                                                        comment does not include any                           name and contact information to be
                                                Legislation, and Analysis.                              confidential information that you or a
                                                [FR Doc. 2017–11817 Filed 6–6–17; 8:45 am]
                                                                                                                                                               made publicly available, you can
                                                                                                        third party may not wish to be posted,                 provide this information on the cover
                                                BILLING CODE 4164–01–P                                  such as medical information, your or                   sheet and not in the body of your
                                                                                                        anyone else’s Social Security number, or               comments and you must identify this
                                                                                                        confidential business information, such                information as ‘‘confidential.’’ Any
                                                DEPARTMENT OF HEALTH AND                                as a manufacturing process. Please note
                                                HUMAN SERVICES                                                                                                 information marked as ‘‘confidential’’
                                                                                                        that if you include your name, contact                 will not be disclosed except in
                                                Food and Drug Administration                            information, or other information that                 accordance with 21 CFR 10.20 and other
                                                                                                        identifies you in the body of your                     applicable disclosure law. For more
                                                [Docket No. FDA–2011–N–0019]                            comments, that information will be                     information about FDA’s posting of
                                                                                                        posted on https://www.regulations.gov.                 comments to public dockets, see 80 FR
                                                Agency Information Collection                             • If you want to submit a comment                    56469, September 18, 2015, or access
                                                Activities; Proposed Collection;                        with confidential information that you
                                                Comment Request; Customer/Partner                                                                              the information at: https://www.gpo.gov/
                                                                                                        do not wish to be made available to the                fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                Service Surveys                                         public, submit the comment as a                        23389.pdf.
                                                AGENCY:    Food and Drug Administration,                written/paper submission and in the                       Docket: For access to the docket to
                                                HHS.                                                    manner detailed (see ‘‘Written/Paper                   read background documents or the
                                                                                                        Submissions’’ and ‘‘Instructions’’).                   electronic and written/paper comments
                                                ACTION:   Notice.
                                                                                                        Written/Paper Submissions                              received, go to https://
                                                SUMMARY:   The Food and Drug                                                                                   www.regulations.gov and insert the
                                                Administration (FDA or Agency) is                          Submit written/paper submissions as                 docket number, found in brackets in the
                                                announcing an opportunity for public                    follows:                                               heading of this document, into the
                                                comment on the proposed collection of                      • Mail/Hand delivery/Courier (for
                                                                                                                                                               ‘‘Search’’ box and follow the prompts
                                                certain information by the Agency.                      written/paper submissions): Division of
                                                                                                                                                               and/or go to the Division of Dockets
                                                Under the Paperwork Reduction Act of                    Dockets Management (HFA–305), Food
                                                                                                                                                               Management, 5630 Fishers Lane, Rm.
                                                1995 (PRA), Federal Agencies are                        and Drug Administration, 5630 Fishers
                                                                                                                                                               1061, Rockville, MD 20852.
                                                required to publish notice in the                       Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                           • For written/paper comments                        FOR FURTHER INFORMATION CONTACT:
                                                Federal Register concerning each                                                                               JonnaLynn Capezzuto, Office of
                                                                                                        submitted to the Division of Dockets
                                                proposed collection of information,                                                                            Operations, Food and Drug
                                                                                                        Management, FDA will post your
                                                including each proposed extension of an                                                                        Administration, Three White Flint
                                                                                                        comment, as well as any attachments,
                                                existing collection of information, and                                                                        North, 10A63, 11601 Landsdown St.,
                                                                                                        except for information submitted,
                                                to allow 60 days for public comment in                                                                         North Bethesda, MD 20852, 301–796–
                                                                                                        marked and identified, as confidential,
                                                response to the notice. This notice                                                                            3794, PRAStaff@fda.hhs.gov.
                                                                                                        if submitted as detailed in
                                                solicits comments on voluntary                                                                                 SUPPLEMENTARY INFORMATION: Under the
                                                                                                        ‘‘Instructions.’’
                                                customer satisfaction service surveys to                   Instructions: All submissions received              PRA (44 U.S.C. 3501–3520), Federal
                                                implement Executive Order 12862.                        must include the Docket No. FDA–                       Agencies must obtain approval from the
                                                DATES: Submit either electronic or                      2011–N–0019 for ‘‘Customer/Partner                     Office of Management and Budget
                                                written comments on the collection of                   Service Surveys.’’ Received comments,                  (OMB) for each collection of
                                                information by August 7, 2017.                          those filed in a timely manner (see                    information they conduct or sponsor.
                                                ADDRESSES: You may submit comments                      ADDRESSES), will be placed in the docket               ‘‘Collection of information’’ is defined
                                                as follows. Please note that late,                      and, except for those submitted as                     in 44 U.S.C. 3502(3) and 5 CFR
                                                untimely filed comments will not be                     ‘‘Confidential Submissions,’’ publicly                 1320.3(c) and includes Agency requests
                                                considered. Electronic comments must                                                                           or requirements that members of the
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        viewable at https://www.regulations.gov
                                                be submitted on or before August 7,                     or at the Division of Dockets                          public submit reports, keep records, or
                                                2017. The https://www.regulations.gov                   Management between 9 a.m. and 4 p.m.,                  provide information to a third party.
                                                electronic filing system will accept                    Monday through Friday.                                 Section 3506(c)(2)(A) of the PRA (44
                                                comments until midnight Eastern Time                       • Confidential Submissions—To                       U.S.C. 3506(c)(2)(A)) requires Federal
                                                at the end of August 7, 2017. Comments                  submit a comment with confidential                     Agencies to provide a 60-day notice in
                                                received by mail/hand delivery/courier                  information that you do not wish to be                 the Federal Register concerning each
                                                (for written/paper submissions) will be                 made publicly available, submit your                   proposed collection of information,


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                                                26498                             Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices

                                                including each proposed extension of an                        when appropriate, and other forms of                    medical device manufacturers;
                                                existing collection of information,                            information technology.                                 consumers; and health professionals.
                                                before submitting the collection to OMB                                                                                The request also covers ‘‘partner’’ (State
                                                                                                               Customer/Partner Service Surveys;
                                                for approval. To comply with this                                                                                      and local governments) customer
                                                                                                               OMB Control Number 0910–0360—
                                                requirement, FDA is publishing notice                          Extension                                               service surveys.
                                                of the proposed collection of                                                                                            FDA will use the information from
                                                                                                                  Under section 903 of the Federal                     these surveys to identify strengths and
                                                information set forth in this document.
                                                                                                               Food, Drug, and Cosmetic Act (21 U.S.C.                 weaknesses in service to customers/
                                                   With respect to the following                               393), FDA is authorized to conduct
                                                collection of information, FDA invites                                                                                 partners and to make improvements.
                                                                                                               research and public information
                                                comments on these topics: (1) Whether                                                                                  The surveys will measure timeliness,
                                                                                                               programs about regulated products and
                                                                                                                                                                       appropriateness and accuracy of
                                                the proposed collection of information                         responsibilities of the Agency.
                                                                                                                                                                       information, courtesy and problem
                                                is necessary for the proper performance                        Executive Order 12862, entitled,
                                                                                                                                                                       resolution in the context of individual
                                                of FDA’s functions, including whether                          ‘‘Setting Customer Service Standard,’’
                                                                                                                                                                       programs.
                                                the information will have practical                            directs Federal Agencies that ‘‘provide
                                                utility; (2) the accuracy of FDA’s                             significant services directly to the                      FDA estimates conducting 15
                                                                                                               public’’ to ‘‘survey customers to                       customer/partner service surveys per
                                                estimate of the burden of the proposed
                                                                                                               determine the kind and quality of                       year, each requiring an average of 15
                                                collection of information, including the
                                                                                                               services they want and their level of                   minutes for review and completion. We
                                                validity of the methodology and                                                                                        estimate respondents to these surveys to
                                                assumptions used; (3) ways to enhance                          satisfaction with existing services.’’ FDA
                                                                                                               is seeking OMB clearance to conduct a                   be between 100 and 20,000 customers.
                                                the quality, utility, and clarity of the                                                                               Some of these surveys will be repeats of
                                                                                                               series of surveys to implement
                                                information to be collected; and (4)                                                                                   earlier surveys for purposes of
                                                                                                               Executive Order 12862. Participation in
                                                ways to minimize the burden of the                                                                                     monitoring customer/partner service
                                                                                                               the surveys is voluntary. This request
                                                collection of information on                                   covers customer/partner service surveys                 and developing long-term data.
                                                respondents, including through the use                         of regulated entities, such as food                       FDA estimates the burden of this
                                                of automated collection techniques,                            processors; cosmetic drug, biologic and                 collection of information as follows:

                                                                                                                                                        Annual
                                                                                                                                   Number of                                      Hours per
                                                                             Type of survey                                                           frequency                                               Total hours
                                                                                                                                  respondents                                     response
                                                                                                                                                     per response

                                                Mail, telephone, web-based ....................................................          55,000                   1   0.25 (15 minutes) ...................         13,750
                                                   1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                  Dated: June 1, 2017.                                         of this ICR will be provided to OMB.                    recipients, as well as their
                                                Anna K. Abram,                                                 OMB will accept further comments from                   subcontracted service providers, funded
                                                Deputy Commissioner for Policy, Planning,                      the public during the review and                        under Parts A, B, C, and D of RWHAP
                                                Legislation, and Analysis.                                     approval period.                                        statute. RWHAP, authorized under Title
                                                [FR Doc. 2017–11822 Filed 6–6–17; 8:45 am]                     DATES: Comments on this ICR should be                   XXVI of the Public Health Service Act,
                                                BILLING CODE 4164–01–P                                         received no later than July 7, 2017.                    as amended by the Ryan White HIV/
                                                                                                               ADDRESSES: Submit your comments,                        AIDS Treatment Extension Act of 2009,
                                                                                                               including the ICR Title, to the desk                    awards funding to recipients to provide
                                                DEPARTMENT OF HEALTH AND                                       officer for HRSA, either by email to                    efficient and effective health care and
                                                HUMAN SERVICES                                                 OIRA_submission@omb.eop.gov or by                       support services, with an emphasis on
                                                                                                               fax to 202–395–5806.                                    providing life-saving and life-extending
                                                Health Resources and Services                                                                                          services for people living with HIV
                                                                                                               FOR FURTHER INFORMATION CONTACT: To
                                                Administration                                                 request a copy of the clearance requests                across the country. HRSA is
                                                                                                               submitted to OMB for review, email the                  streamlining the data collection forms
                                                Agency Information Collection                                                                                          by making the following changes:
                                                Activities: Submission to OMB for                              HRSA Information Collection Clearance
                                                                                                               Officer at paperwork@hrsa.gov or call                      Within Client Demographics:
                                                Review and Approval; Public Comment                                                                                       • Deletion of variable ID 8, ‘‘Self-
                                                Request; Information Collection                                (301) 443–1984.
                                                                                                               SUPPLEMENTARY INFORMATION: When                         Reported Transgender Status’’.
                                                Request Title: Client-Level Data
                                                                                                               submitting comments or requesting                          • Addition of ‘‘Transgender Male to
                                                Reporting System, OMB No. 0915–
                                                                                                               information, please include the                         Female’’, ‘‘Transgender Female to
                                                0323—Revision
                                                                                                               information request collection title for                Male’’, and ‘‘Transgender Other’’ as
                                                AGENCY: Health Resources and Services                          reference, in compliance with Section                   response options for variable ID 7, ‘‘Self-
                                                Administration (HRSA), Department of                           3506(c)(2)(A) of the Paperwork                          Reported Gender’’.
                                                Health and Human Services.                                     Reduction Act of 1995.                                     Within Services:
                                                ACTION: Notice.                                                  Information Collection Request Title:                    • Deletion of ‘‘Parts A and B’’ from
                                                                                                                                                                       the ‘‘Early Intervention Services’’
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                                                                                                               Client-Level Data Reporting System
                                                SUMMARY:  In compliance with the                               OMB No. 0915–0323—Revision.                             response option for variable ID 19,
                                                Paperwork Reduction Act of 1995,                                 Abstract: The Ryan White HIV/AIDS                     ‘‘Core Medical Services Delivered’’.
                                                HRSA has submitted an Information                              Program’s (RWHAP) client-level data                     Deletion of ‘‘Legal Services’’ and
                                                Collection Request (ICR) to the Office of                      reporting system, entitled the RWHAP                    ‘‘Permanency Planning’’, and the
                                                Management and Budget (OMB) for                                Services Report or the Ryan White                       additional of ‘‘Other Professional
                                                review and approval. Comments                                  Services Report (RSR), is designed to                   Services’’ response options for variable
                                                submitted during the first public review                       collect information from grant                          ID 35, ‘‘Support Services’’.


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Document Created: 2017-06-07 02:01:21
Document Modified: 2017-06-07 02:01:21
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.
DatesSubmit either electronic or written comments on the collection of information by August 7, 2017.
ContactJonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]
FR Citation82 FR 26497 

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