81 FR 14860 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range		14860-14862
FR Document		2016-06128

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14860-14862]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0663]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Investigational New Drug Safety Reporting Requirements 
for Human Drug and Biological Products and Safety Reporting 
Requirements for Bioavailability and Bioequivalence Studies in Humans

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 Investigational New Drug 
Safety Reporting Requirements for Human Drug and Biological Products 
and Safety Reporting Requirements for Bioavailability and 
Bioequivalence Studies in Humans.

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0663 for ``Investigational New Drug Safety Reporting 
Requirements for Human Drug and Biological Products and Safety 
Reporting Requirements for Bioavailability and Bioequivalence Studies 
in Humans.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be

[[Page 14861]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 Safety Reporting Requirements for Human Drug 
and Biological Products and Safety Reporting Requirements for 
Bioavailability and Bioequivalence Studies in Humans, OMB Control 
Number 0910-0672--Extension

    In the Federal Register of October 31, 2013 (78 FR 65338), FDA 
published a document entitled ``Investigational New Drug Safety 
Reporting Requirements for Human Drug and Biological Products and 
Safety Reporting Requirements for Bioavailability and Bioequivalence 
Studies in Humans.'' The document clarified the Agency's expectations 
for timely review, evaluation, and submission of relevant and useful 
safety information and implemented internationally harmonized 
definitions and reporting standards for IND safety reports. The 
document also required safety reporting for bioavailability and 
bioequivalence studies. The document was intended to improve the 
utility of Investigational New Drug (IND) safety reports, expedite 
FDA's review of critical safety information, better protect human 
subjects enrolled in clinical trials, and harmonize safety reporting 
requirements internationally.
    The rulemaking included the following information collection under 
the PRA that was not already included in 21 CFR 312.32 and approved 
under OMB control number 0910-0014.
    Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA, 
in an IND safety report, of potential serious risks from clinical 
trials within 15 calendar days for findings from epidemiological 
studies, pooled analyses of multiple studies, or other clinical studies 
that suggest a significant risk in humans exposed to the drug.
    Section 312.32(c)(1)(iii) specifies the requirements for reporting 
to FDA in an IND safety report potential serious risks from clinical 
trials within 15 calendar days for findings from in vitro testing that 
suggest a significant risk to humans.
    Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety 
report within 15 calendar days of any clinically important increase in 
the rate of occurrence of serious suspected adverse reactions over that 
listed in the protocol or investigator brochure.
    The rulemaking also included new information collection under the 
PRA by requiring safety reporting for bioavailability and 
bioequivalence studies (21 CFR 320.31(d)).
    In tables 1 and 2 of this document, the estimates for ``No. of 
Respondents,'' ``No. of Responses per Respondent,'' and ``Total Annual 
Responses'' were obtained from the Center for Drug Evaluation and 
Research (CDER) and the Center for Biologics Evaluation and Research 
(CBER) reports and data management systems for submissions received in 
2013, 2014, and 2015, and from other sources familiar with the number 
of submissions received under the noted 21 CFR section. The estimates 
for ``Hours per Response'' are unchanged based on information from CDER 
and CBER individuals familiar with the burden associated with these 
reports and from prior estimates received from the pharmaceutical 
industry. FDA estimates the burden of this collection of information as 
follows:

                             Table 1--Estimated Annual Reporting Burden--(CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
320.31(d) Bioavailability and                 13              15             195              14           2,730
 Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii)             100               6             600              12           7,200
 IND Safety Reports.............
312.32(c)(1)(iv) IND Safety                   10               1              10              12             120
 Reports........................
                                                                                                 ---------------
    Total (CDER)................  ..............  ..............  ..............  ..............          10,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 14862]]


                             Table 2--Estimated Annual Reporting Burden--(CBER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
320.31(d) Bioavailability and                  1               1               1              14              14
 Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii)             137               4             548              12           6,576
 IND Safety Reports.............
312.32(c)(1)(iv) IND Safety                    5             1.4               7              12              84
 Reports........................
                                                                                                 ---------------
    Total (CBER)................  ..............  ..............  ..............  ..............           6,674
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06128 Filed 3-17-16; 8:45 am]
BILLING CODE 4164-01-P

14862 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—(CBER) 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

320.31(d) Bioavailability and Bioequivalence Safety Re-
ports .................................................................................. 1 1 1 14 14
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 137 4 548 12 6,576
312.32(c)(1)(iv) IND Safety Reports .................................... 5 1.4 7 12 84

Total (CBER) ................................................................ ........................ ........................ ........................ ........................ 6,674
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 14, 2016. Enforcement, Office of Enforcement and unlawful to provide false information to
Leslie Kux, Import Operations, Office of Regulatory the pharmaceutical company.
Associate Commissioner for Policy. Affairs, Food and Drug Administration, Beginning no later than January 2008,
[FR Doc. 2016–06128 Filed 3–17–16; 8:45 am] 12420 Parklawn Dr., Rockville, MD and continuing through at least October
BILLING CODE 4164–01–P
20857, 301–796–4640. 2008, in the Northern District of Illinois,
SUPPLEMENTARY INFORMATION:
Mr. McQuerry knowingly and willfully
falsified, concealed, and covered up by
DEPARTMENT OF HEALTH AND I. Background trick, scheme, and device material facts
HUMAN SERVICES in a matter within the jurisdiction of
Section 306(a)(2)(A) of the FD&C Act FDA, namely that at least four patients
Food and Drug Administration (21 U.S.C. 335a(a)(2)(A)) requires and others were participating in the
debarment of an individual if FDA finds drug clinical trial, when in fact these
[Docket No. FDA–2015–N–3225] that the individual has been convicted patients did not participate in that
of a felony under Federal law for clinical trial. Specifically, between
Wesley A. McQuerry: Debarment Order
conduct relating to the development or January and October 2008, Mr.
AGENCY: Food and Drug Administration, approval, including the process for McQuerry created fifteen to twenty
HHS. development or approval, of any drug fictional patients, whom he claimed
ACTION: Notice. product. Section 306(a)(2)(B) of the were participants in the clinical trial.
FD&C Act requires debarment of an Mr. McQuerry falsified signatures of
SUMMARY: The U.S. Food and Drug individual if FDA finds that the those patients on consent forms and
Administration (FDA or Agency) is individual has been convicted of a falsified doctors’ signatures on medical
issuing an order under the Federal felony under Federal law for conduct evaluations for those patients. He
Food, Drug, and Cosmetic Act (the otherwise relating to the regulation of provided his own blood, stool, and EKG
FD&C Act) permanently debarring any drug product under the FD&C Act. results, which he claimed were
Wesley A. McQuerry from providing On February 10, 2015, the U.S. District provided by the fictional patients. He
services in any capacity to a person that Court for the Northern District of Illinois also transmitted false data and
has an approved or pending drug entered judgment against Mr. McQuerry information to the administrator
product application. FDA bases this for one count of falsifying a material regarding these fictional patients and
order on a finding that Mr. McQuerry fact, in violation of 18 U.S.C. 1001(a)(1). made and caused to be made false
was convicted of a felony under Federal The factual basis for this conviction is statements regarding their participation
law for conduct relating to the as follows: Mr. McQuerry was the study in the study and attendance at office
development or approval, including the coordinator for a drug clinical trial at an visits, all of which he knew would be
process for development or approval, of institution in the Northern District of provided to the pharmaceutical
a drug product and otherwise relating to Illinois. The clinical trial occurred company and to FDA.
the regulation of a drug product under under the authority of FDA, and clinical Mr. McQuerry made false statements
the FD&C Act. Mr. McQuerry was given trial data was required to be submitted to the administrator about the
notice of the proposed permanent to FDA before the drug could be whereabouts of the fictitious trial
debarment and an opportunity to approved for sale in the United States. participants. In particular, on August
request a hearing within the timeframe
As study coordinator, Mr. McQuerry’s 28, 2008, he provided false and
prescribed by regulation. Mr. McQuerry
responsibilities for administering the fraudulent statements to the
failed to respond. Mr. McQuerry’s
clinical trial included, among other administrator regarding the attendance
failure to respond constitutes a waiver
things, coordinating patient visits, of two patients at study visits, knowing
of his right to a hearing concerning this
maintaining patient files, ensuring that that the two patients were not in fact
action.
administrative procedures were enrolled in the study and did not attend
DATES: This order is effective March 18, a single study visit.
followed regarding the collection of
2016. patient data, disbursing American As study coordinator, Mr. McQuerry
asabaliauskas on DSK3SPTVN1PROD with NOTICES

ADDRESSES: Submit applications for Express gift checks to trial participants, was responsible for disbursing gift
special termination of debarment to the and transmitting clinical trial data from checks, which were provided by the
Division of Dockets Management (HFA– the institution to the administrator, pharmaceutical company to patients at
305), Food and Drug Administration, which was administering the clinical various points during the patients’
5630 Fishers Lane, Rm. 1061, Rockville, trial on behalf of the pharmaceutical participation in the clinical trial. Mr.
MD 20852. company. Mr. McQuerry knew that the McQuerry falsely and fraudulently
FOR FURTHER INFORMATION CONTACT: results of the clinical trial would be claimed to have disbursed gift checks
Kenny Shade, (ELEM–4144), Division of reported to FDA, and he knew it was when, in fact, no checks were disbursed

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Document Created: 2018-02-02 15:13:25
Document Modified: 2018-02-02 15:13:25

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 17, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 14860

81 FR 14860 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 53 (March 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration