83_FR_7778 83 FR 7742 - Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing

83 FR 7742 - Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

Page Range7742-7744
FR Document2018-03604

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 administrative practices and procedures; formal evidentiary public hearing.

Federal Register, Volume 83 Issue 36 (Thursday, February 22, 2018)
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7742-7744]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2029]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Practices and Procedures; Formal 
Evidentiary Public Hearing

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 administrative practices and procedures; 
formal evidentiary public hearing.

DATES: Submit either electronic or written comments on the collection 
of information by April 23, 2018.

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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 23, 2018. 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): 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-2014-N-2029 for ``Administrative Practices and Procedures; Formal 
Evidentiary Public Hearing.'' 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

[[Page 7743]]

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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, 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.

Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35, 
and 10.85); Formal Evidentiary Public Hearing (21 CFR 12.22 and 12.45)

(OMB Control Number 0910-0191)--Extension

    The Administrative Procedures Act (5 U.S.C. 553(e)) provides that 
every Agency shall give an interested person the right to petition for 
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) 
sets forth the format and procedures by which an interested person may 
submit to FDA, in accordance with Sec.  10.20 (21 CFR 10.20), a citizen 
petition requesting the Commissioner of Food and Drugs (the 
Commissioner) to issue, amend, or revoke a regulation or order, or to 
take or refrain from taking any other form of administrative action.
    The Commissioner may grant or deny such a petition, in whole or in 
part, and may grant such other relief or take other action as the 
petition warrants. Respondents are individuals or households, State or 
local governments, and not-for-profit institutions or groups.
    Section 10.33 (21 CFR 10.33), issued under section 701(a) of the 
Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)), 
sets forth the format and procedures by which an interested person may 
request reconsideration of part or all of a decision of the 
Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of 
administrative proceedings). A petition for reconsideration must 
contain a full statement in a well-organized format of the factual and 
legal grounds upon which the petition relies. The grounds must 
demonstrate that relevant information and views contained in the 
administrative record were not previously or not adequately considered 
by the Commissioner. The respondent must submit a petition no later 
than 30 days after the decision involved. However, the Commissioner 
may, for good cause, permit a petition to be filed after 30 days. An 
interested person who wishes to rely on information or views not 
included in the administrative record shall submit them with a new 
petition to modify the decision. FDA uses the information provided in 
the request to determine whether to grant the petition for 
reconsideration. Respondents to this collection of information are 
individuals of households, State or local governments, not-for-profit 
institutions, and businesses or other for-profit institutions who are 
requesting from the Commissioner of FDA a reconsideration of a matter.
    Section 10.35 (21 CFR 10.35), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20, the Commissioner to 
stay the effective date of any administrative action.
    Such a petition must do the following: (1) Identify the decision 
involved; (2) state the action requested, including the length of time 
for which a stay is requested; and (3) include a statement of the 
factual and legal grounds on which the interested person relies in 
seeking the stay. FDA uses the information provided in the request to 
determine whether to grant the petition for stay of action.
    Respondents to this information collection are interested persons 
who choose to file a petition for an administrative stay of action.
    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20, an advisory opinion 
from the Commissioner on a matter of general applicability. When making 
a request, the petitioner must provide a concise statement of the 
issues and questions on which an opinion is requested, and a full 
statement of the facts and legal points relevant to the request. 
Respondents to this collection of information are interested persons 
seeking an advisory opinion from the Commissioner.
    FDA has developed a method for electronic submission of citizen 
petitions. The Agency still allows for non-electronic submissions; 
however, electronic submissions of a citizen petition to a specific 
electronic docket presents a simpler and more straightforward approach. 
FDA has created a single docket on https://www.regulations.gov, the 
U.S. Government's consolidated docket website for Federal Agencies, for 
the initial electronic submission of all citizen petitions. The 
advantage to this change is that it ensures efficiency and ease in 
communication, quicker interaction between citizen petitioners and FDA, 
and easier access to FDA to seek input through the citizen petition 
process.
    The regulations in 21 CFR 12.22, issued under section 701(e)(2) of 
the FD&C Act, set forth the instructions for filing objections and 
requests for a hearing on a regulation or order under Sec.  12.20(d) 
(21 CFR 12.20(d)). Objections and requests must be submitted within the 
time specified in Sec.  12.20(e). Each objection, for which a hearing 
has been requested, must be separately numbered and specify the 
provision of the regulation or the proposed order. In addition, each 
objection must include a detailed description and analysis of the 
factual information and any other document, with some exceptions, 
supporting the objection. Failure to include this information 
constitutes a waiver of the right to a hearing on that objection. FDA 
uses the description and analysis to determine whether a hearing 
request is justified. The description and

[[Page 7744]]

analysis may be used only for the purpose of determining whether a 
hearing has been justified under 21 CFR 12.24 and does not limit the 
evidence that may be presented if a hearing is granted.
    Respondents to this information collection are those parties that 
may be adversely affected by an order or regulation.
    Section 12.45 (21 CFR 12.45), issued under section 701 of the FD&C 
Act, sets forth the format and procedures for any interested person to 
file a petition to participate in a formal evidentiary hearing, either 
personally or through a representative. Section 12.45 requires that any 
person filing a notice of participation state their specific interest 
in the proceedings, including the specific issues of fact about which 
the person desires to be heard. This section also requires that the 
notice include a statement that the person will present testimony at 
the hearing and will comply with specific requirements in 21 CFR 12.85, 
or, in the case of a hearing before a Public Board of Inquiry, 
concerning disclosure of data and information by participants (21 CFR 
13.25). In accordance with Sec.  12.45(e) the presiding officer may 
omit a participant's appearance.
    The presiding officer and other participants will use the collected 
information in a hearing to identify specific interests to be 
presented. This preliminary information serves to expedite the 
prehearing conference and commits participation.
    The respondents are individuals or households, State or local 
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
10.30--Citizen petition.........             220               1             220              24           5,280
10.33--Administrative                          6               1               6              10              60
 reconsideration of action......
10.35--Administrative stay of                  6               1               5              10              50
 action.........................
10.85--Requests for Advisory                   4               1               4              16              64
 opinions.......................
12.22--Filing objections and                   5               1               5              20             100
 requests for a hearing on a
 regulation or order............
12.45--Notice of participation..               5               1               5               3              15
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,569
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for this collection of information are based 
on Agency records and experience over the past 3 years. The increase in 
burden hours is due to an increase in the number of respondents under 
several provisions.

    Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03604 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P



                                               7742                                Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices

                                                                                              TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
                                                                                                                                                                       Number of                                                Average
                                                                                                                                          Number of                                               Total annual
                                                              Collection activity/21 CFR section                                                                    disclosures per                                            burden per              Total hours
                                                                                                                                         respondents                                              disclosures
                                                                                                                                                                      respondent                                               disclosure

                                               Notification to Recipients—810.15(a)–(c) ........................                                              2                             1                         2                         12               24
                                               Notification to Recipients; Follow-up—810.15(d) ............                                                   2                             1                         2                          4                8
                                               Notification of Consignees by Recipients—810.15(e) .....                                                      10                             1                        10                          1               10

                                                    Total ..........................................................................   ..........................   ..........................   ........................   ........................             42
                                                  1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                 The burden estimate has not changed                                     at the end of April 23, 2018. Comments       Instructions: All submissions received
                                               for information collection related to                                     received by mail/hand delivery/courier    must include the Docket No. FDA–
                                               section 518(e) of the FD&C Act and part                                   (for written/paper submissions) will be   2014–N–2029 for ‘‘Administrative
                                               810 since the last OMB approval.                                          considered timely if they are             Practices and Procedures; Formal
                                                 Dated: February 14, 2018.                                               postmarked or the delivery service        Evidentiary Public Hearing.’’ Received
                                               Leslie Kux,
                                                                                                                         acceptance receipt is on or before that   comments, those filed in a timely
                                                                                                                         date.                                     manner (see ADDRESSES), will be placed
                                               Associate Commissioner for Policy.
                                                                                                                                                                   in the docket and, except for those
                                               [FR Doc. 2018–03605 Filed 2–21–18; 8:45 am]                               Electronic Submissions
                                                                                                                                                                   submitted as ‘‘Confidential
                                               BILLING CODE 4164–01–P                                                      Submit electronic comments in the       Submissions,’’ publicly viewable at
                                                                                                                         following way:                            https://www.regulations.gov or at the
                                                                                                                           • Federal eRulemaking Portal: https:// Dockets Management Staff between 9
                                               DEPARTMENT OF HEALTH AND
                                                                                                                         www.regulations.gov. Follow the           a.m. and 4 p.m., Monday through
                                               HUMAN SERVICES
                                                                                                                         instructions for submitting comments.     Friday.
                                               Food and Drug Administration                                              Comments submitted electronically,           • Confidential Submissions—To
                                                                                                                         including attachments, to https://        submit a comment with confidential
                                               [Docket No. FDA–2014–N–2029]                                              www.regulations.gov will be posted to     information that you do not wish to be
                                                                                                                         the docket unchanged. Because your        made publicly available, submit your
                                               Agency Information Collection                                             comment will be made public, you are      comments only as a written/paper
                                               Activities; Proposed Collection;                                          solely responsible for ensuring that your submission. You should submit two
                                               Comment Request; Administrative                                           comment does not include any              copies total. One copy will include the
                                               Practices and Procedures; Formal                                          confidential information that you or a    information you claim to be confidential
                                               Evidentiary Public Hearing                                                third party may not wish to be posted,    with a heading or cover note that states
                                               AGENCY:      Food and Drug Administration,                                such as medical information, your or      ‘‘THIS DOCUMENT CONTAINS
                                               HHS.                                                                      anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
                                               ACTION:     Notice.                                                       confidential business information, such Agency will review this copy, including
                                                                                                                         as a manufacturing process. Please note   the claimed confidential information, in
                                               SUMMARY:   The Food and Drug                                              that if you include your name, contact    its consideration of comments. The
                                               Administration (FDA or Agency) is                                         information, or other information that    second copy, which will have the
                                               announcing an opportunity for public                                      identifies you in the body of your        claimed confidential information
                                               comment on the proposed collection of                                     comments, that information will be        redacted/blacked out, will be available
                                               certain information by the Agency.                                        posted on https://www.regulations.gov.    for public viewing and posted on
                                               Under the Paperwork Reduction Act of                                        • If you want to submit a comment       https://www.regulations.gov. Submit
                                               1995 (PRA), Federal Agencies are                                          with confidential information that you    both copies to the Dockets Management
                                               required to publish notice in the                                         do not wish to be made available to the   Staff. If you do not wish your name and
                                               Federal Register concerning each                                          public, submit the comment as a           contact information to be made publicly
                                               proposed collection of information,                                       written/paper submission and in the       available, you can provide this
                                               including each proposed extension of an                                   manner detailed (see ‘‘Written/Paper      information on the cover sheet and not
                                               existing collection of information, and                                   Submissions’’ and ‘‘Instructions’’).      in the body of your comments and you
                                               to allow 60 days for public comment in                                                                              must identify this information as
                                               response to the notice. This notice                                       Written/Paper Submissions
                                                                                                                                                                   ‘‘confidential.’’ Any information marked
                                               solicits comments on administrative                                         Submit written/paper submissions as     as ‘‘confidential’’ will not be disclosed
                                               practices and procedures; formal                                          follows:                                  except in accordance with 21 CFR 10.20
                                               evidentiary public hearing.                                                 • Mail/Hand delivery/Courier (for       and other applicable disclosure law. For
                                               DATES: Submit either electronic or                                        written/paper submissions): Dockets       more information about FDA’s posting
                                               written comments on the collection of                                     Management Staff (HFA–305), Food and of comments to public dockets, see 80
                                               information by April 23, 2018.                                            Drug Administration, 5630 Fishers         FR 56469, September 18, 2015, or access
                                               ADDRESSES: You may submit comments                                        Lane, Rm. 1061, Rockville, MD 20852.      the information at: https://www.gpo.gov/
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                                               as follows. Please note that late,                                          • For written/paper comments            fdsys/pkg/FR-2015-09-18/pdf/2015-
                                               untimely filed comments will not be                                       submitted to the Dockets Management       23389.pdf.
                                               considered. Electronic comments must                                      Staff, FDA will post your comment, as        Docket: For access to the docket to
                                               be submitted on or before April 23,                                       well as any attachments, except for       read background documents or the
                                               2018. The https://www.regulations.gov                                     information submitted, marked and         electronic and written/paper comments
                                               electronic filing system will accept                                      identified, as confidential, if submitted received, go to https://
                                               comments until midnight Eastern Time                                      as detailed in ‘‘Instructions.’’          www.regulations.gov and insert the


                                          VerDate Sep<11>2014       20:10 Feb 21, 2018          Jkt 244001      PO 00000        Frm 00089       Fmt 4703       Sfmt 4703       E:\FR\FM\22FEN1.SGM               22FEN1


                                                                           Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices                                           7743

                                               docket number, found in brackets in the                 amendment, or repeal of a rule. Section               requested; and (3) include a statement of
                                               heading of this document, into the                      10.30 (21 CFR 10.30) sets forth the                   the factual and legal grounds on which
                                               ‘‘Search’’ box and follow the prompts                   format and procedures by which an                     the interested person relies in seeking
                                               and/or go to the Dockets Management                     interested person may submit to FDA, in               the stay. FDA uses the information
                                               Staff, 5630 Fishers Lane, Rm. 1061,                     accordance with § 10.20 (21 CFR 10.20),               provided in the request to determine
                                               Rockville, MD 20852.                                    a citizen petition requesting the                     whether to grant the petition for stay of
                                               FOR FURTHER INFORMATION CONTACT:                        Commissioner of Food and Drugs (the                   action.
                                               Amber Sanford, Office of Operations,                    Commissioner) to issue, amend, or                        Respondents to this information
                                               Food and Drug Administration, Three                     revoke a regulation or order, or to take              collection are interested persons who
                                               White Flint North, 10A–12M, 11601                       or refrain from taking any other form of              choose to file a petition for an
                                               Landsdown St., North Bethesda, MD                       administrative action.                                administrative stay of action.
                                               20852, 301–796–8867, PRAStaff@                             The Commissioner may grant or deny                    Section 10.85 (21 CFR 10.85), issued
                                               fda.hhs.gov.                                            such a petition, in whole or in part, and             under section 701(a) of the FD&C Act,
                                                                                                       may grant such other relief or take other             sets forth the format and procedures by
                                               SUPPLEMENTARY INFORMATION: Under the
                                                                                                       action as the petition warrants.                      which an interested person may request,
                                               PRA (44 U.S.C. 3501–3520), Federal                                                                            in accordance with § 10.20, an advisory
                                                                                                       Respondents are individuals or
                                               Agencies must obtain approval from the                                                                        opinion from the Commissioner on a
                                                                                                       households, State or local governments,
                                               Office of Management and Budget                                                                               matter of general applicability. When
                                                                                                       and not-for-profit institutions or groups.
                                               (OMB) for each collection of                               Section 10.33 (21 CFR 10.33), issued               making a request, the petitioner must
                                               information they conduct or sponsor.                    under section 701(a) of the Federal,                  provide a concise statement of the
                                               ‘‘Collection of information’’ is defined                Food, Drug, and Cosmetic Act (FD&C                    issues and questions on which an
                                               in 44 U.S.C. 3502(3) and 5 CFR                          Act) (21 U.S.C. 371(a)), sets forth the               opinion is requested, and a full
                                               1320.3(c) and includes Agency requests                  format and procedures by which an                     statement of the facts and legal points
                                               or requirements that members of the                     interested person may request                         relevant to the request. Respondents to
                                               public submit reports, keep records, or                 reconsideration of part or all of a                   this collection of information are
                                               provide information to a third party.                   decision of the Commissioner on a                     interested persons seeking an advisory
                                               Section 3506(c)(2)(A) of the PRA (44                    petition submitted under 21 CFR 10.25                 opinion from the Commissioner.
                                               U.S.C. 3506(c)(2)(A)) requires Federal                  (Initiation of administrative                            FDA has developed a method for
                                               Agencies to provide a 60-day notice in                  proceedings). A petition for                          electronic submission of citizen
                                               the Federal Register concerning each                    reconsideration must contain a full                   petitions. The Agency still allows for
                                               proposed collection of information,                     statement in a well-organized format of               non-electronic submissions; however,
                                               including each proposed extension of an                 the factual and legal grounds upon                    electronic submissions of a citizen
                                               existing collection of information,                     which the petition relies. The grounds                petition to a specific electronic docket
                                               before submitting the collection to OMB                 must demonstrate that relevant                        presents a simpler and more
                                               for approval. To comply with this                       information and views contained in the                straightforward approach. FDA has
                                               requirement, FDA is publishing notice                   administrative record were not                        created a single docket on https://
                                               of the proposed collection of                           previously or not adequately considered               www.regulations.gov, the U.S.
                                               information set forth in this document.                 by the Commissioner. The respondent                   Government’s consolidated docket
                                                  With respect to the following                                                                              website for Federal Agencies, for the
                                                                                                       must submit a petition no later than 30
                                               collection of information, FDA invites                                                                        initial electronic submission of all
                                                                                                       days after the decision involved.
                                               comments on these topics: (1) Whether                                                                         citizen petitions. The advantage to this
                                                                                                       However, the Commissioner may, for
                                               the proposed collection of information                                                                        change is that it ensures efficiency and
                                                                                                       good cause, permit a petition to be filed
                                               is necessary for the proper performance                                                                       ease in communication, quicker
                                                                                                       after 30 days. An interested person who
                                               of FDA’s functions, including whether                                                                         interaction between citizen petitioners
                                                                                                       wishes to rely on information or views
                                               the information will have practical                                                                           and FDA, and easier access to FDA to
                                                                                                       not included in the administrative
                                               utility; (2) the accuracy of FDA’s                                                                            seek input through the citizen petition
                                                                                                       record shall submit them with a new
                                               estimate of the burden of the proposed                                                                        process.
                                                                                                       petition to modify the decision. FDA
                                               collection of information, including the                                                                         The regulations in 21 CFR 12.22,
                                                                                                       uses the information provided in the
                                               validity of the methodology and                                                                               issued under section 701(e)(2) of the
                                                                                                       request to determine whether to grant
                                               assumptions used; (3) ways to enhance                   the petition for reconsideration.                     FD&C Act, set forth the instructions for
                                               the quality, utility, and clarity of the                Respondents to this collection of                     filing objections and requests for a
                                               information to be collected; and (4)                    information are individuals of                        hearing on a regulation or order under
                                               ways to minimize the burden of the                      households, State or local governments,               § 12.20(d) (21 CFR 12.20(d)). Objections
                                               collection of information on                            not-for-profit institutions, and                      and requests must be submitted within
                                               respondents, including through the use                  businesses or other for-profit                        the time specified in § 12.20(e). Each
                                               of automated collection techniques,                     institutions who are requesting from the              objection, for which a hearing has been
                                               when appropriate, and other forms of                    Commissioner of FDA a reconsideration                 requested, must be separately numbered
                                               information technology.                                 of a matter.                                          and specify the provision of the
                                               Administrative Practices and                               Section 10.35 (21 CFR 10.35), issued               regulation or the proposed order. In
                                               Procedures (21 CFR 10.30, 10.33, 10.35,                 under section 701(a) of the FD&C Act,                 addition, each objection must include a
                                               and 10.85); Formal Evidentiary Public                   sets forth the format and procedures by               detailed description and analysis of the
                                               Hearing (21 CFR 12.22 and 12.45)                        which an interested person may request,               factual information and any other
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                                                                                                       in accordance with § 10.20, the                       document, with some exceptions,
                                               (OMB Control Number 0910–0191)—                         Commissioner to stay the effective date               supporting the objection. Failure to
                                               Extension                                               of any administrative action.                         include this information constitutes a
                                                 The Administrative Procedures Act (5                     Such a petition must do the following:             waiver of the right to a hearing on that
                                               U.S.C. 553(e)) provides that every                      (1) Identify the decision involved; (2)               objection. FDA uses the description and
                                               Agency shall give an interested person                  state the action requested, including the             analysis to determine whether a hearing
                                               the right to petition for issuance,                     length of time for which a stay is                    request is justified. The description and


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                                               7744                                 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices

                                               analysis may be used only for the                                          representative. Section 12.45 requires                                      presiding officer may omit a
                                               purpose of determining whether a                                           that any person filing a notice of                                          participant’s appearance.
                                               hearing has been justified under 21 CFR                                    participation state their specific interest                                   The presiding officer and other
                                               12.24 and does not limit the evidence                                      in the proceedings, including the                                           participants will use the collected
                                               that may be presented if a hearing is                                      specific issues of fact about which the                                     information in a hearing to identify
                                               granted.                                                                   person desires to be heard. This section                                    specific interests to be presented. This
                                                 Respondents to this information                                          also requires that the notice include a                                     preliminary information serves to
                                               collection are those parties that may be                                   statement that the person will present                                      expedite the prehearing conference and
                                               adversely affected by an order or                                          testimony at the hearing and will                                           commits participation.
                                               regulation.                                                                comply with specific requirements in 21                                       The respondents are individuals or
                                                 Section 12.45 (21 CFR 12.45), issued                                     CFR 12.85, or, in the case of a hearing                                     households, State or local governments,
                                               under section 701 of the FD&C Act, sets                                    before a Public Board of Inquiry,                                           not-for-profit institutions and
                                               forth the format and procedures for any                                                                                                                businesses, or other for-profit groups
                                                                                                                          concerning disclosure of data and
                                               interested person to file a petition to                                                                                                                and institutions.
                                                                                                                          information by participants (21 CFR
                                               participate in a formal evidentiary                                                                                                                      FDA estimates the burden of this
                                               hearing, either personally or through a                                    13.25). In accordance with § 12.45(e) the                                   collection of information as follows:
                                                                                                             TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                         Number of                                                Average
                                                                                                                                              Number of                   responses                Total annual
                                                                               21 CFR section                                                                                                                                   burden per              Total hours
                                                                                                                                             respondents                     per                    responses                    response
                                                                                                                                                                         respondent

                                               10.30—Citizen petition .........................................................                               220                           1                       220                          24            5,280
                                               10.33—Administrative reconsideration of action .................                                                 6                           1                         6                          10               60
                                               10.35—Administrative stay of action ...................................                                          6                           1                         5                          10               50
                                               10.85—Requests for Advisory opinions ..............................                                              4                           1                         4                          16               64
                                               12.22—Filing objections and requests for a hearing on a
                                                 regulation or order ............................................................                                5                           1                          5                        20              100
                                               12.45—Notice of participation ..............................................                                      5                           1                          5                         3               15

                                                     Total ..............................................................................   ........................   ........................   ........................   ........................          5,569
                                                  1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                 The burden estimates for this                                            Products Advisory Committee and the                                         Consultants, Center for Biologics
                                               collection of information are based on                                     Microbiology Devices Panel of the                                           Evaluation and Research (CBER), Food
                                               Agency records and experience over the                                     Medical Devices Advisory Committee.                                         and Drug Administration, 10903 New
                                               past 3 years. The increase in burden                                       The Committee will function as a                                            Hampshire Ave., Silver Spring, MD
                                               hours is due to an increase in the                                         medical device panel to provide advice                                      20993–0002, Bldg. 71, Rm. 6132, at 240–
                                               number of respondents under several                                        and recommendations to the Agency on                                        402–8054, bryan.emery@fda.hhs.gov
                                               provisions.                                                                classification of devices. The Committee                                    and Rm. 6270 at 240–402–8106,
                                                 Dated: February 14, 2018.                                                will also provide advice and                                                joanne.lipkind@fda.hhs.gov
                                               Leslie Kux,
                                                                                                                          recommendations to the FDA on                                               respectively, or FDA Advisory
                                                                                                                          research programs in the Office of Blood                                    Committee Information Line, 1–800–
                                               Associate Commissioner for Policy.
                                                                                                                          Research and Review. At least one                                           741–8138 (301–443–0572 in the
                                               [FR Doc. 2018–03604 Filed 2–21–18; 8:45 am]
                                                                                                                          portion of the meeting will be closed to                                    Washington, DC area). A notice in the
                                               BILLING CODE 4164–01–P                                                     the public.                                                                 Federal Register about last minute
                                                                                                                          DATES: The meeting will be held on                                          modifications that impact a previously
                                                                                                                          March 21, 2018, from 8 a.m. to 5:15 p.m.                                    announced advisory committee meeting
                                               DEPARTMENT OF HEALTH AND                                                                                                                               cannot always be published quickly
                                               HUMAN SERVICES                                                             and March 22, 2018, from 8 a.m. to 5
                                                                                                                          p.m.                                                                        enough to provide timely notice.
                                               Food and Drug Administration                                                                                                                           Therefore, you should always check the
                                                                                                                          ADDRESSES:    FDA White Oak Campus,                                         Agency’s website at https://
                                               [Docket No. FDA–2018–N–0467]                                               10903 New Hampshire Ave., Building                                          www.fda.gov/AdvisoryCommittees/
                                                                                                                          31 Conference Center, the Great Room                                        default.htm and scroll down to the
                                               Joint Meeting of the Blood Products                                        (Rm. 1503, sections B&C), Silver Spring,                                    appropriate advisory committee meeting
                                               Advisory Committee and the                                                 MD 20993–0002. Answers to commonly                                          link, or call the advisory committee
                                               Microbiology Devices Panel of the                                          asked questions including information                                       information line to learn about possible
                                               Medical Devices Advisory Committee;                                        regarding special accommodations due                                        modifications before coming to the
                                               Notice of Meeting                                                          to a disability, visitor parking, and                                       meeting. For those unable to attend in
                                                                                                                          transportation may be accessed at:                                          person, the meeting will also be
                                               AGENCY:       Food and Drug Administration,
daltland on DSKBBV9HB2PROD with NOTICES




                                                                                                                          https://www.fda.gov/                                                        available via webcast. The webcast will
                                               HHS.
                                                                                                                          AdvisoryCommittees/                                                         be available at the following link for
                                               ACTION:      Notice.                                                       AboutAdvisoryCommittees/                                                    both days: https://collaboration.fda.gov/
                                               SUMMARY: The Food and Drug                                                 ucm408555.htm.                                                              bpacmdac2018/.
                                               Administration (FDA) announces a                                           FOR FURTHER INFORMATION CONTACT:                                            SUPPLEMENTARY INFORMATION:
                                               forthcoming joint public advisory                                          Bryan Emery or Joanne Lipkind,                                                 Agenda: During the morning session
                                               committee meeting of the Blood                                             Division of Scientific Advisors and                                         on March 21, 2018, the Joint Committee


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Document Created: 2018-02-22 02:51:18
Document Modified: 2018-02-22 02:51:18
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 April 23, 2018.
ContactAmber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation83 FR 7742 

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