[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5551-5552]
[DOCID:fr30ja08-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

January 24, 2008.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using

the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                  Docket No.                    Date received                Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. Project No. 6132-000..................         1-16-08  Commission Staff.\1\
Exempt:
    1. CP07-208-000..........................         1-16-08  Hon. David J. Cappiello.
    2. Project No. 2576-000..................         1-17-08  Hon. Timothy V. Johnson.
----------------------------------------------------------------------------------------------------------------
\1\ There is a memorandum to the file concerning conversation between Commission Staff concerning phone calls
  received from Mr. John C. Jones.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-1620 Filed 1-29-08; 8:45 am]

BILLING CODE 6717-01-P


(c) Offering timely transportation to each directly-involved
employee's home terminal, if necessary;
    (d) Offering counseling, guidance, and other appropriate support
services to each directly-involved employee;
    (e) Permitting relief from the duty tour(s) subsequent to the
critical incident, for an amount of time to be determined by each
railroad, if requested by a directly-involved employee as may be
necessary and reasonable;
    (f) Permitting each directly-involved employee such additional
leave from normal duty as may be necessary and reasonable to receive
preventive services or treatment related to the incident or both; and
    (g) Addressing how the railroad's employees operating or otherwise
working on track owned by or operated over by a different railroad will
be afforded the protections of the plan.

Sec.  272.103P  Submission of critical incident stress plan for
approval by the Federal Railroad Administration.

    (a) Each railroad subject to this part shall submit to the Federal
Railroad Administration, Office of Railroad Safety, 1200 New Jersey
Avenue SE, Washington, DC 20590, for approval, the railroad's critical
incident stress plan no later than 12 months after the effective date
of the final rule.
    (b) Each railroad subject to this part shall--
    (1) Simultaneously with its filing with FRA, serve, either by hard
copy or electronically, a copy of the submission filed pursuant to
paragraph (a) of this section or a material modification filed pursuant
to paragraph (e) of this section on the international/national
president of any non-profit employee labor organization representing a
class or craft of the railroad's employees subject to this part; and
    (2) Include in its submission filed pursuant to paragraph (a) of
this section or a material modification filed pursuant to paragraph (e)
of this section a statement affirming that the railroad has complied
with the requirements of paragraph (b)(1) of this section, together
with a list of the names and addresses of the persons served.
    (c) Not later than 90 days after the date of filing a submission
pursuant to paragraph (a) of this section or a material modification
pursuant to paragraph (e) of this section, a labor organization
representing a class or craft of the railroad's employees subject to
this part, may file a comment on the submission or material
modification.
    (1) Each comment shall be submitted to the Associate Administrator
for Railroad Safety/Chief Safety Officer, FRA, 1200 New Jersey Avenue
SE., Washington, DC 20590; and
    (2) The commenter shall certify that a copy of the comment was
served on the railroad.
    (d) A critical incident stress plan is considered approved for
purposes of this part if and when FRA notifies the railroad in writing
that the critical incident stress plan is approved, or 120 days after
FRA has received the railroad's critical incident stress plan,
whichever occurs first.
    (e) After FRA's initial approval of a railroad's critical incident
stress plan, if the railroad makes a material modification of the
critical incident stress plan, the railroad shall submit to FRA for
approval a copy of the critical incident stress plan as it has been
revised to reflect the material modification within 30 days of making
the material modification.
    (f) Upon FRA approval of a railroad's critical incident stress plan
and any material modification of the critical incident stress plan, the
railroad must make a copy of the railroad's plan and the material
modification available to the railroad's employees identified in Sec.
272.7.
    (g) Each railroad subject to this part must make a copy of the
railroad's plan available for inspection and reproduction by the FRA.

Sec.  272.105  Option to file critical incident stress plan
electronically.

    (a) Each railroad to which this part applies is authorized to file
by electronic means any critical incident stress plan submissions
required under this part in accordance with the requirements of this
section.
    (b) Prior to the railroad submitting its first critical incident
stress plan submission electronically, the railroad shall provide the
Associate Administrator with the following information in writing:
    (1) The name of the railroad;
    (2) The names of two individuals, including job titles, who will be
the railroad's points of contact and will be the only individuals
allowed access to FRA's secure document submission site;
    (3) The mailing addresses for the railroad's points of contact;
    (4) The railroad's system or main headquarters address located in
the United States;
    (5) The email addresses for the railroad's points of contact; and
    (6) The daytime telephone numbers for the railroad's points of
contact.
    (c) A railroad that electronically submits an initial critical
incident stress plan, informational filing, or new portions or
revisions to an approved critical incident stress plan required by this
part shall be considered to have provided its consent to receive
approval or disapproval notices from FRA by email.
    (d) A request for electronic submission or FRA review of written
materials shall be addressed to the Associate Administrator for
Railroad Safety/Chief Safety Officer, Federal Railroad Administration,
1200 New Jersey Avenue SE., Washington, DC 20590.
    (e) FRA may electronically store any materials required by this
part regardless of whether the railroad that submits the materials does
so by delivering the written materials to the Associate Administrator
and opts not to submit the materials electronically.
    (f) A railroad that opts not to submit the materials required by
this part electronically, but provides one or more email addresses in
its submission, shall be considered to have provided its consent to
receive approval or disapproval notices from FRA by email or mail.

Appendix A to Part 272--Schedule of Civil Penalties

    A civil penalty may be assessed against an individual only for a
willful violation. The Administrator reserves the right to assess a
penalty of up to $105,000 for any violation where circumstances
warrant. See 49 U.S.C. 21301, 21304 and 49 CFR part 209, Appendix A.

    Issued in Washington, DC, on June 11, 2013.
Joseph C. Szabo,
Administrator.

[FR Doc. 2013-15417 Filed 6-27-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50102-50107]
[FR Doc No: 2018-21610]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1721]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 regulations under which the
clinical investigation of the safety and effectiveness of unapproved
new drugs and biological products can be conducted.

DATES: Submit either electronic or written comments on the collection
of information by December 3, 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 December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 3, 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-1721 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Investigational New Drug
Applications.'' 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.gpo.gov/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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Investigational New Drug Application--21 CFR Part 312

OMB Control Number 0910-0014--Extension

    This information collection supports FDA regulations in 21 CFR part
312 covering Investigational New Drugs. Part 312 implements provisions
of section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(i)) to issue regulations under which the clinical
investigation of the safety and effectiveness of unapproved new drugs
and biological products can be conducted.
    FDA is charged with implementing statutory requirements that ensure
drug products marketed in the United States are shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the FD&C Act (21 U.S.C. 355(a))
provides that a new drug may not be introduced or delivered for
introduction into interstate commerce in the United States unless FDA
has previously approved a new drug application (NDA). FDA approves an
NDA only if the sponsor of the application first demonstrates that the
drug is safe and effective for the conditions prescribed, recommended,
or suggested in the product's labeling. Proof must consist, in part, of
adequate and well-controlled studies, including studies in humans, that
are conducted by qualified experts.
    The investigational new drug application (IND) regulations under 21
CFR part 312 establish reporting requirements that include an initial
application as well as amendments to that application, reports on
significant revisions of clinical investigation plans, and information
on a drug's safety or effectiveness. In addition, the sponsor is
required to give FDA an annual summary of the previous year's clinical
experience. The regulations also include recordkeeping requirements
pertaining to the disposition of drugs, records pertaining to
individual case histories, and certain other documentation verifying
the fulfillment of responsibilities by clinical investigators.
    Submissions are reviewed by medical officers and other Agency
scientific reviewers assigned responsibility for overseeing a specific
study. The details and complexity of these requirements are dictated by
the scientific procedures and human subject safeguards that must be
followed in the clinical tests of investigational new drugs.
    The IND information collection requirements provide the means by
which FDA can monitor the clinical investigation of the safety and
effectiveness of unapproved new drugs and biological products,
including the following: (1) Monitor the safety of ongoing clinical
investigations; (2) determine whether the clinical testing of a drug
should be authorized; (3) ensure production of reliable data on the
metabolism and pharmacological action of the drug in humans; (4) obtain
timely information on adverse reactions to the drug; (5) obtain
information on side effects associated with increasing doses; (6)
obtain information on the drug's effectiveness; (7) ensure the design
of well-controlled, scientifically valid studies; and (8) obtain other
information pertinent to determining whether clinical testing should be
continued and information related to the protection of human subjects.
Without the information provided by industry as required under the IND
regulations, FDA cannot authorize or monitor the clinical
investigations that must be conducted before authorizing the sale and
general use of new drugs. These reports enable FDA to monitor a study's
progress, to ensure the safety of subjects, to ensure that a study will
be conducted ethically, and to increase the likelihood that the sponsor
will conduct studies that will be useful in determining whether the
drug should be marketed and available for use in medical practice.
    To assist respondents with certain reporting requirements under
part 312, we have developed two forms: Form FDA 1571 entitled,
``Investigational New Drug Application (IND)'' and Form FDA 1572
entitled, ``Statement of Investigator.'' Anyone who intends to conduct
a clinical investigation must submit Form FDA 1571 as instructed. The
reporting elements include: (1) A cover sheet containing background
information on the sponsor and investigator; (2) a table of contents;
(3) an introductory statement and general investigational plan; (4) an
investigator's brochure describing the drug substance; (5) a protocol
for each planned study; (6) chemistry, manufacturing, and control
information for each investigation; (7) pharmacology and toxicology
information for each investigation; and (8) previous human experience
with the investigational drug. Form FDA 1572 is executed and submitted
by the IND sponsor before an investigator may participate in an

investigation. It includes background information on the investigator
as well as the investigation, and a general outline of the planned
investigation and study protocol.
    Below, we estimate the burden of the information collection as
reported by FDA's Center for Drug Evaluation and Research (CDER) and
Center for Biologics Evaluation and Research (CBER) as follows:

                      Table 1--Estimated Annual Reporting Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.   312.2(e); Requests for                400               1             400              24           9,600
 FDA advice on the applicability
 of part 312 to a planned
 clinical investigation.........
Sec.   312.8; Requests to charge              74            1.23              91              48           4,368
 for an investigational drug....
Sec.   312.10; Requests to waive              86            1.84             158              24           3,792
 a requirement in part 312......
Sec.   312.23(a) through (f);              2,187             1.7           3,718           1,600       5,948,800
 IND content and format
 (including Form FDA 1571)......
Sec.   312.30(a) through (e);              4,418            5.52          24,387             284       6,925,908
 Protocol amendments............
Sec.   312.31(b); Information              6,691            3.32          22,214             100       2,221,400
 amendments.....................
Sec.   312.32(c) and (d); IND                867           15.78          13,681              32         437,792
 safety reports.................
Sec.   312.33(a) through (f);              3,376            2.86           9,655             360       3,475,800
 IND annual reports.............
Sec.   312.38(b) and (c);                    930            1.61           1,497              28          41,916
 Notifications of withdrawal of
 an IND.........................
Sec.   312.42; Sponsor requests              198            1.38             273             284          77,532
 that a clinical hold be
 removed, including sponsor
 submission of a complete
 response to the issues
 identified in the clinical hold
 order..........................
Sec.   312.44(c) and (d);                     12            1.16              14              16             224
 Sponsor responses to FDA when
 IND is terminated..............
Sec.   312.45(a) and (b);                    231            1.84             425              12           5,100
 Sponsor requests for or
 responses to an inactive status
 determination of an IND by FDA.
Sec.   312.47; Meetings,                     122            1.51             184             160          29,440
 including ``End-of-Phase 2''
 meetings and ``Pre-NDA''
 meetings.......................
Sec.   312.54(a); Sponsor                     15             2.4              36              48           1,728
 submissions to FDA concerning
 investigations involving an
 exception from informed consent
 under Sec.   50.24.............
Sec.   312.54(b); Sponsor                      2               1               2              48              96
 notifications to FDA and others
 concerning an IRB determination
 that it cannot approve research
 because it does not meet the
 criteria in the exception from
 informed consent in Sec.
 50.24(a).......................
Sec.   312.56(b), (c), and (d);            6,100               7          42,700              80       3,416,000
 Sponsor notifications to FDA
 and others resulting from: (1)
 The sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects...
Sec.   312.58(a); Sponsor's                   73               1              73               8             584
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
Sec.   312.70; During the                      4               1               4              40             160
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
Sec.   312.110(b)(4) and (b)(5);              11           26.28             289              75          21,675
 Written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
Sec.   312.120(b); Submissions             1,414            8.62          12,189              32         390,048
 to FDA of ``supporting
 information'' related to the
 use of foreign clinical studies
 not conducted under an IND.....
Sec.   312.120(c); Waiver                     35            2.34              82              24           1,968
 requests submitted to FDA
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
Sec.   312.130; Requests for                   3               1               3               8              24
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
Sec.  Sec.   312.310(b) and                  935            2.77           2,590               8          20,720
 312.305(b); Submissions related
 to expanded access and
 treatment of an individual
 patient........................
Sec.   312.310(d); Submissions               480            2.15           1,032              16          16,512
 related to emergency use of an
 investigational new drug.......
Sec.  Sec.   312.315(c) and                  118            2.52             297             120          35,640
 312.305(b); Submissions related
 to expanded access and
 treatment of an intermediate-
 size patient population........
Sec.   312.320(b); Submissions                10            12.9             129             300          38,700
 related to a treatment IND or
 treatment protocol.............
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............      23,125,527
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                    Table 2--Estimated Annual Recordkeeping Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec.   312.52(a); Sponsor                  1,300               1           1,300               2           2,600
 records for the transfer of
 obligations to a contract
 research organization..........
Sec.   312.57; Sponsor                    13,000               1          13,000             100       1,300,000
 recordkeeping showing the
 receipt, shipment, or other
 disposition of the
 investigational drug and any
 financial interests............
Sec.   312.62(a); Investigator            13,000               1          13,000              40         520,000
 recordkeeping of the
 disposition of drugs...........
Sec.   312.62(b); Investigator            13,000               1          13,000              40         520,000
 recordkeeping of case histories
 of individuals.................
Sec.   312.160(a)(3); Records                547            1.43             782          * 0.50             391
 pertaining to the shipment of
 drugs for investigational use
 in laboratory research animals
 or in vitro tests..............
Sec.   312.160(c); Shipper                   547            1.43             782          * 0.50             391
 records of alternative
 disposition of unused drugs....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,343,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.

               Table 3--Estimated Annual Third-Party Disclosure Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Sec.   312.53(c); Investigator             1,732            7.94          13,752              80       1,100,160
 reports submitted to the
 sponsor, including Form FDA
 1572, curriculum vitae,
 clinical protocol, and
 financial disclosure...........
Sec.   312.55(a); Investigator               995               4           3,980              48         191,040
 brochures submitted by the
 sponsor to each investigator...
Sec.   312.55(b); Sponsor                    995               4           3,980              48         191,040
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
Sec.   312.64; Investigator               13,000               1          13,000              24         312,000
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,794,240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                       Table 4--Estimated Annual Reporting Burden for Biologics (CBER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
312.2(e) Requests for FDA advice             217            1.18             256              24           6,144
 on the applicability of part
 312 to a planned clinical
 investigation..................
312.8 Requests to charge for an               20            1.50              30              48           1,440
 investigational drug...........
312.10 Requests to waive a                     2               1               2              24              48
 requirement in part 312........
312.23(a) through (f) IND                    335            1.35             452           1,600         723,200
 content and format.............
312.30(a) through (e) Protocol               694            5.84           4,053             284       1,151,052
 amendments.....................
312.31(b) Information amendments              77            2.43             187             100          18,700
312.32(c) and (d) IND Safety                 161            8.83           1,422              32          45,504
 reports........................
312.33(a) through (f) IND Annual             745            2.14           1,594             360         573,840
 reports........................
312.38(b) and (c) Notifications              134            1.69             226              28           6,328
 of withdrawal of an IND........

312.42 Sponsor requests that a                67            1.30              87             284          24,708
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d) Sponsor                     34            1.15              39              16             624
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b) Sponsor                     55            1.38              76              12             912
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47 Meetings, including ``End-             88            1.75             154             160          24,640
 of-Phase 2'' meetings and ``Pre-
 NDA'' meetings.................
312.53(c) Investigator reports               453            6.33           2,867              80         229,360
 submitted to the sponsor,
 including Form FDA-1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure.....................
312.54(a) Sponsor submissions to               1               1               1              48              48
 FDA concerning investigations
 involving an exception from
 informed consent under 21 CFR
 50.24..........................
312.54(b) Sponsor notifications                1               1               1              48              48
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in 50.24(a)............
312.55(a) Number of investigator             239            1.91             456              48          21,888
 brochures submitted by the
 sponsor to each investigator...
312.55(b) Number of sponsor                  243            4.95           1,203              48          57,744
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
312.56(b), (c), and (d) Sponsor              108            2.21             239              80          19,120
 notifications to FDA and others
 resulting from: (1) The
 sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects...
312.58(a) Number of sponsor's                  7               1               7               8              56
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
312.64 Number of investigator              2,728            3.82          10,421              24         250,104
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
312.70 During the                              5               1               5              40             200
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5) Number               18               1              18              75           1,350
 of written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b) Number of submissions             280            9.82           2,750              32          88,000
 to FDA of ``supporting
 information'' related to the
 use of foreign clinical studies
 not conducted under an IND.....
312.120(c) Number of waiver                    7            2.29              16              24             384
 requests submitted to FDA
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.130 Number of requests for               350            1.34             469               8           3,752
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
312.310(b) and 312.305(b) Number              78            1.08              84               8             672
 of submissions related to
 expanded access and treatment
 of an individual patient.......
312.310(d) Number of submissions              76            2.76             210              16           3,360
 related to emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b) Number               9               1               9             120           1,080
 of submissions related to
 expanded access and treatment
 of an intermediate-size patient
 population.....................
312.320(b) Number of submissions               1               1               1             300             300
 related to a treatment IND or
 treatment protocol.............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,254,606
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                     Table 5--Estimated Annual Recordkeeping Burden for Biologics (CBER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
312.52(a) Sponsor records for                 75            1.40             105               2             210
 the transfer of obligations to
 a contract research
 organization...................
312.57 Sponsor recordkeeping                 335            2.70             904             100          90,400
 showing the receipt, shipment,
 or other disposition of the
 investigational drug, and any
 financial interests............
312.62(a) Investigator                       453               1             453              40          18,120
 recordkeeping of the
 disposition of drugs...........
312.62(b) Investigator                       453               1             453              40          18,120
 recordkeeping of case histories
 of individuals.................
312.160(a)(3) Records pertaining             111            1.40             155           * 0.5              78
 to the shipment of drugs for
 investigational use in
 laboratory research animals or
 in vitro tests.................
312.160(c) Shipper records of                111            1.40             155           * 0.5              78
 alternative disposition of
 unused drugs...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         127,006
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.

    Because we have received an increased number of IND submissions
since the last OMB approval of the information collection, we have
increased our estimate of the associated burden accordingly.

    Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21610 Filed 10-3-18; 8:45 am]
 BILLING CODE 4164-01-P