82_FR_50347 82 FR 50139 - Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information

82 FR 50139 - Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 208 (October 30, 2017)

Page Range50139-50141
FR Document2017-23519

The Food and Drug Administration (FDA, the Agency, or we) is requesting information to assist in identifying standard development organizations (SDOs) that meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures Act), which was signed into law on December 13, 2016.

Federal Register, Volume 82 Issue 208 (Monday, October 30, 2017)
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50139-50141]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23519]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5925]


Standard Development Organizations Whose Susceptibility Test 
Interpretive Criteria Standards May Be Recognized by the Food and Drug 
Administration; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for information.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
requesting information to assist in identifying standard development 
organizations (SDOs) that meet the requirements in the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures 
Act), which was signed into law on December 13, 2016.

DATES: Submit either electronic or written comments on the notice by 
November 29, 2017.

ADDRESSES:  You may submit comments and information as follows. Please 
note that late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before November 29, 2017. 
The https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of November 29, 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

[[Page 50140]]

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-5925 for ``Standard Development Organizations Whose 
Susceptibility Test Interpretive Criteria Standards May Be Recognized 
by FDA; Request for Information.'' 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 Dockets Management Staff 
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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1182 or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial susceptibility testing is used to determine if 
certain microorganisms that are isolated from a patient with an 
infection are likely to be killed or inhibited by a particular 
antimicrobial drug at the concentrations of the drug that are 
attainable at the site of infection. Historically, susceptibility test 
interpretive criteria has been contained in the Microbiology subsection 
of antimicrobial drug labeling, and there have been significant 
challenges associated with ensuring that this information is up-to-date 
for individual antimicrobial drug labels. For some time, FDA and other 
stakeholders have recognized that susceptibility test interpretive 
criteria standards established by nationally or internationally 
recognized SDOs can be useful sources of information to identify and 
update susceptibility test interpretive criteria.
    Section 511A of the FD&C Act (21 U.S.C. 360a) was added by section 
3044 of the Cures Act (Pub. L. 114-255), which was signed into law on 
December 13, 2016. This provision clarifies FDA's authority to identify 
and efficiently update susceptibility test interpretive criteria, 
including through the recognition by FDA of standards established by 
SDOs. It also clarifies that sponsors of antimicrobial susceptibility 
testing devices may rely upon listed susceptibility test interpretive 
criteria to support premarket authorization of their devices, provided 
they meet certain conditions, which provides for a more streamlined 
process for incorporating up-to-date information into such devices.
    Section 511A of the FD&C Act requires FDA to establish within 1 
year after the date of enactment of the Cures Act an interpretive 
criteria Web site containing a list of FDA-recognized susceptibility 
test interpretive criteria standards, as well as other susceptibility 
test interpretive criteria identified by FDA. The list of standards 
consists of new or updated susceptibility test interpretive criteria 
standards with respect to legally marketed antimicrobial drugs that 
have been: (1) Established by nationally or internationally recognized 
SDOs that meet the requirements under section 511A(b)(2)(A)(i) of the 
FD&C Act and (2) recognized, in whole or in part, by FDA, pursuant to 
section 511A(c) of the FD&C Act.
    Section 511A(b)(2)(A)(i) of the FD&C Act requires that in order for 
FDA to recognize, in whole or in part, new or updated susceptibility 
test interpretive criteria standards established by an SDO, the SDO 
must: (1) Be a nationally or internationally recognized SDO that 
establishes and maintains procedures to address potential conflicts of 
interest and ensure transparent decision making; (2) hold meetings to 
ensure that there is an opportunity for public input by interested 
parties, and establishes and maintains processes to ensure that such 
input is considered in decision making; and (3) permit its standards to 
be made publicly available, through the National Library of Medicine or 
a similar source acceptable to the Secretary of Health and Human 
Services.

II. Issues for Consideration and Request for Information

    FDA is currently identifying SDOs that meet the requirements under 
section 511A(b)(2)(A)(i) of the FD&C Act and invites submission of 
information relevant to this task. FDA is particularly interested in 
publicly available information illustrating how an SDO has national or 
international recognition, information illustrating an SDO's 
established and maintained procedures on how the SDO addresses 
potential conflicts of interest and ensures transparent decision-
making, information illustrating that an SDO holds open meetings and 
has established and maintained processes to ensure that public input by 
interested parties is considered in decision-making, and information 
illustrating that an SDO's standards are made publicly available 
through the National

[[Page 50141]]

Institutes of Health/National Library of Medicine or a similar source. 
When providing this information, please provide weblinks to where this 
information is publicly available. This information may assist in FDA's 
determination of which SDOs may fulfill the statutory requirements.

    Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23519 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P



                                                                             Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices                                              50139

                                                addressed adhesive label to assist that                 received prior to finalizing this                     DEPARTMENT OF HEALTH AND
                                                office in processing your request.                      guidance.                                             HUMAN SERVICES
                                                FOR FURTHER INFORMATION CONTACT:                        II. Significance of Guidance                          Food and Drug Administration
                                                Trisha Eustaquio, Center for Devices
                                                and Radiological Health, Food and Drug                     This guidance is being issued                      [Docket No. FDA–2017–N–5925]
                                                Administration, 10903 New Hampshire                     consistent with FDA’s good guidance
                                                Ave., Bldg. 66, Rm. 1529, Silver Spring,                practices regulation (21 CFR 10.115).                 Standard Development Organizations
                                                MD 20993–0002, 301–796–5214.                            The guidance represents the current                   Whose Susceptibility Test Interpretive
                                                SUPPLEMENTARY INFORMATION:                              thinking of FDA on ‘‘Product Labeling                 Criteria Standards May Be Recognized
                                                                                                        for Certain Ultrasonic Surgical Aspirator             by the Food and Drug Administration;
                                                I. Background                                           Devices.’’ It does not establish any rights           Request for Information
                                                   FDA is issuing this guidance to                      for any person and is not binding on                  AGENCY:    Food and Drug Administration,
                                                recommend the addition of a specific                    FDA or the public. You can use an                     HHS.
                                                safety statement to the product labeling                alternative approach if it satisfies the
                                                                                                                                                              ACTION:   Request for information.
                                                of certain ultrasonic surgical aspirator                requirements of the applicable statutes
                                                devices. This guidance applies to                       and regulations. This guidance is not                 SUMMARY:    The Food and Drug
                                                ultrasonic surgical aspirator devices                   subject to Executive Order 12866.                     Administration (FDA, the Agency, or
                                                with indications for use in laparoscopic                                                                      we) is requesting information to assist in
                                                surgery, open surgery, or gynecologic                   III. Electronic Access
                                                                                                                                                              identifying standard development
                                                surgery, as such surgeries can include                     Persons interested in obtaining a copy             organizations (SDOs) that meet the
                                                gynecologic procedures. Ultrasonic                      of the guidance may do so by                          requirements in the Federal Food, Drug,
                                                surgical aspirator devices are surgical                 downloading an electronic copy from                   and Cosmetic Act (FD&C Act), of the
                                                tools intended to fragment, emulsify,                   the internet. A search capability for all             21st Century Cures Act (Cures Act),
                                                and aspirate hard and soft tissue.                      Center for Devices and Radiological                   which was signed into law on December
                                                However, the mechanism of action of                                                                           13, 2016.
                                                                                                        Health guidance documents is available
                                                ultrasonic surgical aspirator devices                                                                         DATES: Submit either electronic or
                                                                                                        at https://www.fda.gov/MedicalDevices/
                                                creates the potential for tissue                                                                              written comments on the notice by
                                                dissemination. In light of this risk, FDA               DeviceRegulationandGuidance/
                                                                                                        GuidanceDocuments/default.htm.                        November 29, 2017.
                                                is providing a specific labeling
                                                                                                        Guidance documents are also available                 ADDRESSES: You may submit comments
                                                recommendation in this guidance
                                                                                                        at https://www.regulations.gov. Persons               and information as follows. Please note
                                                regarding use of these devices in the
                                                                                                        unable to download an electronic copy                 that late, untimely filed comments will
                                                removal of uterine fibroids.
                                                                                                        of ‘‘Product Labeling for Certain                     not be considered. Electronic comments
                                                   FDA is aware that ultrasonic surgical                                                                      must be submitted on or before
                                                aspirator devices are sometimes used to                 Ultrasonic Surgical Aspirator Devices;
                                                                                                        Guidance for Industry and Food and                    November 29, 2017. The https://
                                                treat advanced malignancy through                                                                             www.regulations.gov electronic filing
                                                cytoreduction (also known as                            Drug Administration Staff’’ may send an
                                                                                                                                                              system will accept comments until
                                                debulking). When used in advanced                       email request to CDRH-Guidance@
                                                                                                                                                              midnight Eastern Time at the end of
                                                cancers, the risk of adverse clinical                   fda.hhs.gov to receive an electronic
                                                                                                                                                              November 29, 2017. Comments received
                                                effects from tissue dissemination may be                copy of the document. Please use the
                                                                                                                                                              by mail/hand delivery/courier (for
                                                small compared to the device’s potential                document number 1500072 to identify                   written/paper submissions) will be
                                                benefits. In certain clinical                           the guidance you are requesting.                      considered timely if they are
                                                circumstances, however, the unintended                                                                        postmarked or the delivery service
                                                                                                        IV. Paperwork Reduction Act of 1995
                                                dissemination of cancerous cells may                                                                          acceptance receipt is on or before that
                                                have a significant adverse effect that                    This guidance refers to previously                  date.
                                                outweighs any demonstrated benefits.                    approved collections of information
                                                Specifically, use of an ultrasonic                                                                            Electronic Submissions
                                                                                                        found in FDA regulations. These
                                                surgical aspirator device during                        collections of information are subject to               Submit electronic comments in the
                                                treatment for symptomatic uterine                       review by the Office of Management and                following way:
                                                fibroids on a woman with an occult                      Budget (OMB) under the Paperwork                        • Federal eRulemaking Portal:
                                                uterine sarcoma could result in                                                                               https://www.regulations.gov. Follow the
                                                                                                        Reduction Act of 1995 (44 U.S.C. 3501–
                                                dissemination of this cancer. Therefore,                                                                      instructions for submitting comments.
                                                                                                        3520). The collections of information in
                                                FDA recommends that manufacturers of                                                                          Comments submitted electronically,
                                                                                                        21 CFR part 807, subpart E have been
                                                ultrasonic surgical aspirator devices                                                                         including attachments, to https://
                                                with indications for use in laparoscopic                approved under OMB control number
                                                                                                        0910–0120 and the collections of                      www.regulations.gov will be posted to
                                                surgery, open surgery, or gynecologic                                                                         the docket unchanged. Because your
                                                surgery prominently include a specific                  information in 21 CFR part 801 have
                                                                                                                                                              comment will be made public, you are
                                                contraindication in their product                       been approved under OMB control
                                                                                                                                                              solely responsible for ensuring that your
                                                labeling that the device is not indicated               number 0910–0485.                                     comment does not include any
                                                for and should not be used for the                        Dated: October 25, 2017.                            confidential information that you or a
                                                fragmentation, emulsification, and                                                                            third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        Lauren Silvis,
                                                aspiration of uterine fibroids.                                                                               such as medical information, your or
                                                                                                        Chief of Staff.
                                                   In the Federal Register on November                  [FR Doc. 2017–23520 Filed 10–27–17; 8:45 am]
                                                                                                                                                              anyone else’s Social Security number, or
                                                10, 2016 (81 FR 79028), FDA announced                                                                         confidential business information, such
                                                                                                        BILLING CODE 4164–01–P
                                                the availability of the draft guidance and                                                                    as a manufacturing process. Please note
                                                interested parties were invited to                                                                            that if you include your name, contact
                                                comment by January 9, 2017. FDA has                                                                           information, or other information that
                                                considered all of the public comments                                                                         identifies you in the body of your


                                           VerDate Sep<11>2014   17:59 Oct 27, 2017   Jkt 244001   PO 00000   Frm 00024   Fmt 4703   Sfmt 4703   E:\FR\FM\30OCN1.SGM   30OCN1


                                                50140                        Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices

                                                comments, that information will be                      except in accordance with 21 CFR 10.20                devices, provided they meet certain
                                                posted on https://www.regulations.gov.                  and other applicable disclosure law. For              conditions, which provides for a more
                                                  • If you want to submit a comment                     more information about FDA’s posting                  streamlined process for incorporating
                                                with confidential information that you                  of comments to public dockets, see 80                 up-to-date information into such
                                                do not wish to be made available to the                 FR 56469, September 18, 2015, or access               devices.
                                                public, submit the comment as a                         the information at: https://www.gpo.gov/                 Section 511A of the FD&C Act
                                                written/paper submission and in the                     fdsys/pkg/FR-2015-09-18/pdf/2015-                     requires FDA to establish within 1 year
                                                manner detailed (see ‘‘Written/Paper                    23389.pdf.                                            after the date of enactment of the Cures
                                                Submissions’’ and ‘‘Instructions’’).                       Docket: For access to the docket to                Act an interpretive criteria Web site
                                                                                                        read background documents or the                      containing a list of FDA-recognized
                                                Written/Paper Submissions
                                                                                                        electronic and written/paper comments                 susceptibility test interpretive criteria
                                                   Submit written/paper submissions as                  received, go to https://                              standards, as well as other susceptibility
                                                follows:                                                www.regulations.gov and insert the                    test interpretive criteria identified by
                                                   • Mail/Hand delivery/Courier (for                    docket number, found in brackets in the               FDA. The list of standards consists of
                                                written/paper submissions): Dockets                     heading of this document, into the                    new or updated susceptibility test
                                                Management Staff (HFA–305), Food and                    ‘‘Search’’ box and follow the prompts                 interpretive criteria standards with
                                                Drug Administration, 5630 Fishers                       and/or go to the Dockets Management                   respect to legally marketed
                                                Lane, Rm. 1061, Rockville, MD 20852.                    Staff, 5630 Fishers Lane, Rm. 1061,                   antimicrobial drugs that have been: (1)
                                                   • For written/paper comments                                                                               Established by nationally or
                                                                                                        Rockville, MD 20852.
                                                submitted to the Dockets Management                                                                           internationally recognized SDOs that
                                                Staff, FDA will post your comment, as                   FOR FURTHER INFORMATION CONTACT:
                                                                                                        Katherine Schumann, Center for Drug                   meet the requirements under section
                                                well as any attachments, except for                                                                           511A(b)(2)(A)(i) of the FD&C Act and (2)
                                                information submitted, marked and                       Evaluation and Research, Food and
                                                                                                        Drug Administration, 10903 New                        recognized, in whole or in part, by FDA,
                                                identified, as confidential, if submitted                                                                     pursuant to section 511A(c) of the FD&C
                                                as detailed in ‘‘Instructions.’’                        Hampshire Ave., Bldg. 22, Rm. 6242,
                                                                                                        Silver Spring, MD 20993–0002, 301–                    Act.
                                                   Instructions: All submissions received                                                                        Section 511A(b)(2)(A)(i) of the FD&C
                                                must include the Docket No. FDA–                        796–1182 or Katherine.Schumann@
                                                                                                                                                              Act requires that in order for FDA to
                                                2017–N–5925 for ‘‘Standard                              fda.hhs.gov.
                                                                                                                                                              recognize, in whole or in part, new or
                                                Development Organizations Whose                         SUPPLEMENTARY INFORMATION:                            updated susceptibility test interpretive
                                                Susceptibility Test Interpretive Criteria                                                                     criteria standards established by an
                                                Standards May Be Recognized by FDA;                     I. Background
                                                                                                                                                              SDO, the SDO must: (1) Be a nationally
                                                Request for Information.’’ Received                        Antimicrobial susceptibility testing is            or internationally recognized SDO that
                                                comments, those filed in a timely                       used to determine if certain                          establishes and maintains procedures to
                                                manner (see ADDRESSES), will be placed                  microorganisms that are isolated from a               address potential conflicts of interest
                                                in the docket and, except for those                     patient with an infection are likely to be            and ensure transparent decision making;
                                                submitted as ‘‘Confidential                             killed or inhibited by a particular                   (2) hold meetings to ensure that there is
                                                Submissions,’’ publicly viewable at                     antimicrobial drug at the concentrations              an opportunity for public input by
                                                https://www.regulations.gov or at the                   of the drug that are attainable at the site           interested parties, and establishes and
                                                Dockets Management Staff between 9                      of infection. Historically, susceptibility            maintains processes to ensure that such
                                                a.m. and 4 p.m., Monday through                         test interpretive criteria has been                   input is considered in decision making;
                                                Friday.                                                 contained in the Microbiology                         and (3) permit its standards to be made
                                                   • Confidential Submissions—To                        subsection of antimicrobial drug                      publicly available, through the National
                                                submit a comment with confidential                      labeling, and there have been significant             Library of Medicine or a similar source
                                                information that you do not wish to be                  challenges associated with ensuring that              acceptable to the Secretary of Health
                                                made publicly available, submit your                    this information is up-to-date for                    and Human Services.
                                                comments only as a written/paper                        individual antimicrobial drug labels.
                                                submission. You should submit two                       For some time, FDA and other                          II. Issues for Consideration and Request
                                                copies total. One copy will include the                 stakeholders have recognized that                     for Information
                                                information you claim to be confidential                susceptibility test interpretive criteria                FDA is currently identifying SDOs
                                                with a heading or cover note that states                standards established by nationally or                that meet the requirements under
                                                ‘‘THIS DOCUMENT CONTAINS                                internationally recognized SDOs can be                section 511A(b)(2)(A)(i) of the FD&C Act
                                                CONFIDENTIAL INFORMATION.’’ The                         useful sources of information to identify             and invites submission of information
                                                Agency will review this copy, including                 and update susceptibility test                        relevant to this task. FDA is particularly
                                                the claimed confidential information, in                interpretive criteria.                                interested in publicly available
                                                its consideration of comments. The                         Section 511A of the FD&C Act (21                   information illustrating how an SDO has
                                                second copy, which will have the                        U.S.C. 360a) was added by section 3044                national or international recognition,
                                                claimed confidential information                        of the Cures Act (Pub. L. 114–255),                   information illustrating an SDO’s
                                                redacted/blacked out, will be available                 which was signed into law on December                 established and maintained procedures
                                                for public viewing and posted on                        13, 2016. This provision clarifies FDA’s              on how the SDO addresses potential
                                                https://www.regulations.gov. Submit                     authority to identify and efficiently                 conflicts of interest and ensures
                                                both copies to the Dockets Management                   update susceptibility test interpretive               transparent decision-making,
                                                Staff. If you do not wish your name and                 criteria, including through the                       information illustrating that an SDO
sradovich on DSK3GMQ082PROD with NOTICES




                                                contact information to be made publicly                 recognition by FDA of standards                       holds open meetings and has
                                                available, you can provide this                         established by SDOs. It also clarifies                established and maintained processes to
                                                information on the cover sheet and not                  that sponsors of antimicrobial                        ensure that public input by interested
                                                in the body of your comments and you                    susceptibility testing devices may rely               parties is considered in decision-
                                                must identify this information as                       upon listed susceptibility test                       making, and information illustrating
                                                ‘‘confidential.’’ Any information marked                interpretive criteria to support                      that an SDO’s standards are made
                                                as ‘‘confidential’’ will not be disclosed               premarket authorization of their                      publicly available through the National


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                                                                             Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices                              50141

                                                Institutes of Health/National Library of                Electronic Submissions                    comments only as a written/paper
                                                Medicine or a similar source. When                        Submit electronic comments in the       submission. You should submit two
                                                providing this information, please                      following way:                            copies total. One copy will include the
                                                provide weblinks to where this                            • Federal eRulemaking Portal: https:// information you claim to be confidential
                                                information is publicly available. This                 www.regulations.gov. Follow the           with a heading or cover note that states
                                                information may assist in FDA’s                         instructions for submitting comments.     ‘‘THIS DOCUMENT CONTAINS
                                                determination of which SDOs may                         Comments submitted electronically,        CONFIDENTIAL INFORMATION.’’ The
                                                fulfill the statutory requirements.                     including attachments, to https://        Agency will review this copy, including
                                                  Dated: October 25, 2017.                              www.regulations.gov will be posted to     the claimed confidential information, in
                                                                                                        the docket unchanged. Because your        its consideration of comments. The
                                                Lauren Silvis,
                                                                                                                                                  second copy, which will have the
                                                Chief of Staff.                                         comment will be made public, you are
                                                                                                                                                  claimed confidential information
                                                [FR Doc. 2017–23519 Filed 10–27–17; 8:45 am]            solely responsible for ensuring that your
                                                                                                                                                  redacted/blacked out, will be available
                                                                                                        comment does not include any
                                                BILLING CODE 4164–01–P                                                                            for public viewing and posted on
                                                                                                        confidential information that you or a
                                                                                                                                                  https://www.regulations.gov. Submit
                                                                                                        third party may not wish to be posted,
                                                                                                                                                  both copies to the Dockets Management
                                                DEPARTMENT OF HEALTH AND                                such as medical information, your or
                                                                                                                                                  Staff. If you do not wish your name and
                                                HUMAN SERVICES                                          anyone else’s Social Security number, or
                                                                                                                                                  contact information to be made publicly
                                                                                                        confidential business information, such
                                                                                                                                                  available, you can provide this
                                                Food and Drug Administration                            as a manufacturing process. Please note
                                                                                                                                                  information on the cover sheet and not
                                                                                                        that if you include your name, contact
                                                [Docket No. FDA–2008–N–0334]                                                                      in the body of your comments and you
                                                                                                        information, or other information that
                                                                                                                                                  must identify this information as
                                                Agency Information Collection                           identifies you in the body of your
                                                                                                                                                  ‘‘confidential.’’ Any information marked
                                                Activities; Proposed Collection;                        comments, that information will be
                                                                                                                                                  as ‘‘confidential’’ will not be disclosed
                                                Comment Request; Postmarketing                          posted on https://www.regulations.gov.
                                                                                                                                                  except in accordance with 21 CFR 10.20
                                                Safety Reports for Human Drug and                         • If you want to submit a comment
                                                                                                                                                  and other applicable disclosure law. For
                                                Biological Products: Electronic                         with confidential information that you
                                                                                                                                                  more information about FDA’s posting
                                                Submission Requirements                                 do not wish to be made available to the
                                                                                                                                                  of comments to public dockets, see 80
                                                                                                        public, submit the comment as a
                                                AGENCY:    Food and Drug Administration,                                                          FR 56469, September 18, 2015, or access
                                                                                                        written/paper submission and in the
                                                HHS.                                                                                              the information at: https://www.gpo.gov/
                                                                                                        manner detailed (see ‘‘Written/Paper
                                                ACTION:   Notice.                                                                                 fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                                                                        Submissions’’ and ‘‘Instructions’’).
                                                                                                                                                  23389.pdf.
                                                SUMMARY:    The Food and Drug                           Written/Paper Submissions                    Docket: For access to the docket to
                                                Administration (FDA or Agency) is                                                                 read background documents or the
                                                                                                          Submit written/paper submissions as
                                                announcing an opportunity for public                                                              electronic and written/paper comments
                                                                                                        follows:
                                                comment on the proposed collection of                                                             received, go to https://
                                                                                                          • Mail/Hand delivery/Courier (for
                                                certain information by the Agency.                                                                www.regulations.gov and insert the
                                                                                                        written/paper submissions): Dockets
                                                Under the Paperwork Reduction Act of                                                              docket number, found in brackets in the
                                                                                                        Management Staff (HFA–305), Food and
                                                1995 (PRA), Federal Agencies are                                                                  heading of this document, into the
                                                                                                        Drug Administration, 5630 Fishers
                                                required to publish notice in the                                                                 ‘‘Search’’ box and follow the prompts
                                                                                                        Lane, Rm. 1061, Rockville, MD 20852.
                                                Federal Register concerning each                                                                  and/or go to the Dockets Management
                                                                                                          • For written/paper comments
                                                proposed collection of information,                                                               Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                        submitted to the Dockets Management
                                                including each proposed extension of an                                                           Rockville, MD 20852.
                                                                                                        Staff, FDA will post your comment, as
                                                existing collection of information, and                 well as any attachments, except for       FOR FURTHER INFORMATION CONTACT:
                                                to allow 60 days for public comment in                  information submitted, marked and         Domini Bean, Office of Operations,
                                                response to the notice. This notice                     identified, as confidential, if submitted Food and Drug Administration, Three
                                                solicits comments on the requirements                   as detailed in ‘‘Instructions.’’          White Flint North, 10A–12M, 11601
                                                for electronic submission of                              Instructions: All submissions received Landsdown St., North Bethesda, MD
                                                postmarketing safety reports for human                  must include the Docket No. FDA–          20852, 301–796–5733, PRAStaff@
                                                drug and biological products.                           2008–N–0334 for ‘‘Agency Information      fda.hhs.gov.
                                                DATES: Submit either electronic or                      Collection Activities; Proposed           SUPPLEMENTARY INFORMATION: Under the
                                                written comments on the collection of                   Collection; Comment Request;              PRA (44 U.S.C. 3501–3520), Federal
                                                information by December 29, 2017.                       Postmarketing Safety Reports for Human Agencies must obtain approval from the
                                                ADDRESSES: You may submit comments                      Drug and Biological Products: Electronic Office of Management and Budget
                                                as follows. Please note that late,                      Submission Requirements.’’ Received       (OMB) for each collection of
                                                untimely filed comments will not be                     comments, those filed in a timely         information they conduct or sponsor.
                                                considered. Electronic comments must                    manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
                                                be submitted on or before December 29,                  in the docket and, except for those       in 44 U.S.C. 3502(3) and 5 CFR
                                                2017. The https://www.regulations.gov                   submitted as ‘‘Confidential               1320.3(c) and includes Agency requests
                                                electronic filing system will accept                    Submissions,’’ publicly viewable at       or requirements that members of the
                                                comments until midnight Eastern Time                    https://www.regulations.gov or at the     public submit reports, keep records, or
sradovich on DSK3GMQ082PROD with NOTICES




                                                at the end of December 29, 2017.                        Dockets Management Staff between 9        provide information to a third party.
                                                Comments received by mail/hand                          a.m. and 4 p.m., Monday through           Section 3506(c)(2)(A) of the PRA (44
                                                delivery/courier (for written/paper                     Friday.                                   U.S.C. 3506(c)(2)(A)) requires Federal
                                                submissions) will be considered timely                    • Confidential Submissions—To           Agencies to provide a 60-day notice in
                                                if they are postmarked or the delivery                  submit a comment with confidential        the Federal Register concerning each
                                                service acceptance receipt is on or                     information that you do not wish to be    proposed collection of information,
                                                before that date.                                       made publicly available, submit your      including each proposed extension of an


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Document Created: 2017-10-28 00:29:03
Document Modified: 2017-10-28 00:29:03
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
ActionRequest for information.
DatesSubmit either electronic or written comments on the notice by November 29, 2017.
ContactKatherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301- 796-1182 or [email protected]
FR Citation82 FR 50139 

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