82 FR 40006 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 162 (August 23, 2017)

Page Range		40006-40007
FR Document		2017-17842

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 162 (Wednesday, August 23, 2017)

[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40006-40007]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17842]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0493]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Additional Criteria 
and Procedures for Classifying Over-the-Counter Drugs as Generally 
Recognized as Safe and Effective and Not Misbranded

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 22, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0688. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Additional Criteria and Procedures for Classifying Over-the-Counter 
Drugs as Generally Recognized as Safe and Effective and Not 
Misbranded--21 CFR 330.14, OMB Control Number 0910-0688--Revision

    This information collection supports Agency regulations. 
Specifically, FDA regulations at Sec.  330.14 (21 CFR 330.14) establish 
additional criteria and procedures for classifying over-the-counter 
(OTC) drugs as generally recognized as safe and effective and not 
misbranded. These regulations state that

[[Page 40007]]

OTC drug products introduced into the U.S. market after the OTC drug 
review began and OTC drug products without any marketing experience in 
the United States can be evaluated under the monograph process if the 
conditions (e.g., active ingredients) meet certain ``time and extent'' 
criteria outlined in the regulations. The regulations allow a time and 
extent application (TEA) to be submitted to us by any party for our 
consideration to include new conditions in the OTC drug monograph 
system. TEAs must provide evidence described in Sec.  330.14(c) 
demonstrating that the condition is eligible for inclusion in the 
monograph system. (Section 330.14(d) specifies the number of copies and 
address for submission of a TEA.) If a condition is found eligible, any 
interested parties can submit safety and effectiveness information as 
explained in Sec.  330.14(f). Safety and effectiveness data includes 
the data and information listed in Sec.  330.10(a)(2), a listing of all 
serious adverse drug experiences that may have occurred (Sec.  
330.14(f)(2)), and an official or proposed compendial monograph (Sec.  
330.14(i)).
    Based on our experience with submissions we have received under 
Sec.  330.14, we estimate that we will receive two TEAs and two safety 
and effectiveness submissions each year, and that it will take 
approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a 
comprehensive safety and effectiveness submission. This information is 
reflected in rows 1 and 2 of table 1.
    Recently FDA revised its regulations at 21 CFR part 330 (81 FR 
84465, November 23, 2016), thus adding 6 hours to FDA's estimated 
annual reporting burden for the information collection. Specifically, 
Sec.  330.14(j) clarifies the requirements on content and format 
criteria for a safety and effectiveness data submission, and provides 
procedures for FDA's review of the submissions and determination of 
whether a submission is sufficiently complete to permit a substantive 
review. Section 330.14(j)(3) describes the process for cases in which 
FDA refuses to file the safety and effectiveness data submission. Under 
Sec.  330.14(j)(3), if FDA refuses to file the submission, the Agency 
will notify the sponsor in writing, state the reason(s) for the 
refusal, and provide the sponsor with 30 days in which to submit a 
written request for an informal conference with the Agency about 
whether the Agency should file the submission. We estimate that 
approximately one respondent will annually submit a request for an 
informal conference, and that preparing and submitting each request 
will take approximately 1 hour. This is reflected in row 3 of table 1.
    Under Sec.  330.14(j)(4)(iii), the safety and effectiveness data 
submission must contain a signed statement that the submission 
represents a complete safety and effectiveness data submission and that 
the submission includes all the safety and effectiveness data and 
information available to the sponsor at the time of the submission, 
whether positive or negative. We estimate that approximately two 
respondents annually will submit such signed statements, and that 
preparing and submitting each signed statement will take approximately 
1 hour. This is reflected in row 4 of table 1.
    Under Sec.  330.14(k)(1), FDA, in response to a written request 
from a sponsor, may withdraw consideration of a TEA submitted under 
Sec.  330.14(c) or a safety and effectiveness data submission submitted 
under Sec.  330.14(f). We estimate that approximately one respondent 
will annually submit such a request, and that preparing and submitting 
the request will take approximately 1 hour. This is reflected in row 5 
of table 1.
    Under Sec.  330.14(k)(2), a sponsor may request that FDA not 
withdraw consideration of a TEA or safety and effectiveness data 
submission. We estimate one respondent will annually submit such a 
request, and that preparing and submitting the request will take 
approximately 2 hours. This is reflected in row 6 of table 1.
    In the Federal Register of May 30, 2017 (82 FR 24723), we published 
a 60-day notice requesting public comment on the proposed extension of 
this collection of information. No comments were received.
    We therefore estimate the burden of this collection of information 
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR part 330; activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
330.14(c) and (d); time and                    2               1               2           1,525           3,050
 extent application and
 submission of information......
330.14(f) and (i); safety and                  2               1               2           2,350           4,700
 effectiveness data.............
330.14(j)(3); sponsor request                  1               1               1               1               1
 for informal conference........
330.14(j)(4); sponsor signed                   2               1               2               1               2
 statement that submission is
 complete.......................
330.14(k)(l); sponsor request                  1               1               1               1               1
 for FDA withdraw of TEA
 consideration..................
330.14(k)(2); sponsor request                  1               1               1               2               2
 for FDA to not deem submission
 withdrawn......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,756
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17842 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P

40006 Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices

DEPARTMENT OF HEALTH AND Information and Regulatory Affairs, medical device or radiological product
HUMAN SERVICES OMB, Attn: FDA Desk Officer, Fax: 202– or its use. Because, prior to the
395–7285, or emailed to oira_ establishment of the electronic
Food and Drug Administration submission@omb.eop.gov. All submission process for voluntary
[Docket No. FDA–2017–N–1095] comments should be identified with the allegations to CDRH, there had been no
OMB control number 0910–0769. Also established guidelines or instructions on
Agency Information Collection include the FDA docket number found how to submit an allegation to CDRH,
Activities; Submission for Office of in brackets in the heading of this allegations often contained minimal
Management and Budget Review; document. information and were received via
Comment Request; Electronic FOR FURTHER INFORMATION CONTACT: phone calls, emails, or conversationally.
Submission Process for Voluntary Amber Sanford, Office of Operations, CDRH has established a consistent
Allegations to the Center for Devices Food and Drug Administration, Three format and process for the submission of
and Radiological Health White Flint North, 10A63, 11601 device allegations that enhances our
Landsdown St., North Bethesda, MD timeliness in receiving, assessing, and
AGENCY: Food and Drug Administration, evaluating voluntary allegations. The
HHS. 20852, 301–796–8867, PRAStaff@
fda.hhs.gov. information provided in the allegations
ACTION: Notice. received by CDRH may be used to
SUPPLEMENTARY INFORMATION: In clarify the recurrence or emergence of
SUMMARY: The Food and Drug compliance with 44 U.S.C. 3507, FDA
Administration (FDA) is announcing significant device-related risks to the
has submitted the following proposed general public and the need to initiate
that a proposed collection of collection of information to OMB for
information has been submitted to the educational outreach or regulatory
review and clearance. action to minimize or mitigate identified
Office of Management and Budget
(OMB) for review and clearance under Electronic Submission Process for risks.
the Paperwork Reduction Act of 1995. Voluntary Allegations to the Center for In the Federal Register of May 30,
DATES: Fax written comments on the Devices and Radiological Health—OMB 2017 (82 FR 24716) FDA published a 60-
collection of information by September Control Number 0910–0769—Extension day notice requesting public comment
22, 2017. This information collection request on the proposed collection of
ADDRESSES: To ensure that comments on collects information voluntarily information. No comments were
the information collection are received, submitted to Center for Devices and received.
OMB recommends that written Radiological Health (CDRH) on actual or FDA estimates the burden of this
comments be faxed to the Office of potential health risk concerns about a collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent

Electronic submission of voluntary allegations to 700 1 700 .25 (15 minutes) .......... 175
CDRH.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: August 17, 2017. SUMMARY: The Food and Drug Food and Drug Administration, Three
Leslie Kux, Administration (FDA) is announcing White Flint North, 10A63, 11601
Associate Commissioner for Policy. that a proposed collection of Landsdown St., North Bethesda, MD
[FR Doc. 2017–17836 Filed 8–22–17; 8:45 am] information has been submitted to the 20852, 301–796–5733, PRAStaff@
BILLING CODE 4164–01–P
Office of Management and Budget fda.hhs.gov.
(OMB) for review and clearance under
SUPPLEMENTARY INFORMATION: In
the Paperwork Reduction Act of 1995.
compliance with 44 U.S.C. 3507, FDA
DEPARTMENT OF HEALTH AND DATES: Fax written comments on the
has submitted the following proposed
HUMAN SERVICES collection of information by September collection of information to OMB for
22, 2017. review and clearance.
Food and Drug Administration ADDRESSES: To ensure that comments on
[Docket No. FDA–2010–N–0493] the information collection are received, Additional Criteria and Procedures for
OMB recommends that written Classifying Over-the-Counter Drugs as
Agency Information Collection comments be faxed to the Office of Generally Recognized as Safe and
Activities; Submission for Office of Information and Regulatory Affairs, Effective and Not Misbranded—21 CFR
Management and Budget Review; OMB, Attn: FDA Desk Officer, Fax: 202– 330.14, OMB Control Number 0910–
Comment Request; Additional Criteria 395–7285, or emailed to oira_ 0688—Revision
asabaliauskas on DSKBBXCHB2PROD with NOTICES

and Procedures for Classifying Over- submission@omb.eop.gov. All This information collection supports
the-Counter Drugs as Generally comments should be identified with the Agency regulations. Specifically, FDA
Recognized as Safe and Effective and OMB control number 0910–0688. Also regulations at § 330.14 (21 CFR 330.14)
Not Misbranded include the FDA docket number found establish additional criteria and
in brackets in the heading of this procedures for classifying over-the-
AGENCY: Food and Drug Administration, document.
HHS. counter (OTC) drugs as generally
FOR FURTHER INFORMATION CONTACT: recognized as safe and effective and not
ACTION: Notice.
Domini Bean, Office of Operations, misbranded. These regulations state that

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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40007

OTC drug products introduced into the information is reflected in rows 1 and 2 safety and effectiveness data and
U.S. market after the OTC drug review of table 1. information available to the sponsor at
began and OTC drug products without Recently FDA revised its regulations the time of the submission, whether
any marketing experience in the United at 21 CFR part 330 (81 FR 84465, positive or negative. We estimate that
States can be evaluated under the November 23, 2016), thus adding 6 approximately two respondents
monograph process if the conditions hours to FDA’s estimated annual annually will submit such signed
(e.g., active ingredients) meet certain reporting burden for the information statements, and that preparing and
‘‘time and extent’’ criteria outlined in collection. Specifically, § 330.14(j) submitting each signed statement will
the regulations. The regulations allow a clarifies the requirements on content take approximately 1 hour. This is
time and extent application (TEA) to be and format criteria for a safety and reflected in row 4 of table 1.
submitted to us by any party for our effectiveness data submission, and Under § 330.14(k)(1), FDA, in
consideration to include new conditions provides procedures for FDA’s review of response to a written request from a
in the OTC drug monograph system. the submissions and determination of sponsor, may withdraw consideration of
TEAs must provide evidence described whether a submission is sufficiently a TEA submitted under § 330.14(c) or a
in § 330.14(c) demonstrating that the complete to permit a substantive review. safety and effectiveness data submission
condition is eligible for inclusion in the Section 330.14(j)(3) describes the submitted under § 330.14(f). We
monograph system. (Section 330.14(d) process for cases in which FDA refuses estimate that approximately one
specifies the number of copies and to file the safety and effectiveness data respondent will annually submit such a
address for submission of a TEA.) If a submission. Under § 330.14(j)(3), if FDA request, and that preparing and
condition is found eligible, any refuses to file the submission, the submitting the request will take
interested parties can submit safety and Agency will notify the sponsor in approximately 1 hour. This is reflected
effectiveness information as explained writing, state the reason(s) for the in row 5 of table 1.
in § 330.14(f). Safety and effectiveness refusal, and provide the sponsor with 30 Under § 330.14(k)(2), a sponsor may
days in which to submit a written request that FDA not withdraw
data includes the data and information
request for an informal conference with consideration of a TEA or safety and
listed in § 330.10(a)(2), a listing of all
the Agency about whether the Agency effectiveness data submission. We
serious adverse drug experiences that
should file the submission. We estimate estimate one respondent will annually
may have occurred (§ 330.14(f)(2)), and
that approximately one respondent will submit such a request, and that
an official or proposed compendial
annually submit a request for an preparing and submitting the request
monograph (§ 330.14(i)). informal conference, and that preparing will take approximately 2 hours. This is
Based on our experience with and submitting each request will take reflected in row 6 of table 1.
submissions we have received under approximately 1 hour. This is reflected In the Federal Register of May 30,
§ 330.14, we estimate that we will in row 3 of table 1. 2017 (82 FR 24723), we published a 60-
receive two TEAs and two safety and Under § 330.14(j)(4)(iii), the safety day notice requesting public comment
effectiveness submissions each year, and effectiveness data submission must on the proposed extension of this
and that it will take approximately contain a signed statement that the collection of information. No comments
1,525 hours to prepare a TEA and 2,350 submission represents a complete safety were received.
hours to prepare a comprehensive safety and effectiveness data submission and We therefore estimate the burden of
and effectiveness submission. This that the submission includes all the this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR part 330; activity responses per burden per Total hours
respondents responses
respondent response

330.14(c) and (d); time and extent application and submis-
sion of information ............................................................ 2 1 2 1,525 3,050
330.14(f) and (i); safety and effectiveness data .................. 2 1 2 2,350 4,700
330.14(j)(3); sponsor request for informal conference ........ 1 1 1 1 1
330.14(j)(4); sponsor signed statement that submission is
complete ........................................................................... 2 1 2 1 2
330.14(k)(l); sponsor request for FDA withdraw of TEA
consideration .................................................................... 1 1 1 1 1
330.14(k)(2); sponsor request for FDA to not deem sub-
mission withdrawn ............................................................ 1 1 1 2 2

Total .............................................................................. ........................ ........................ ........................ ........................ 7,756
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: August 17, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17842 Filed 8–22–17; 8:45 am]
BILLING CODE 4164–01–P

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Document Created: 2017-08-22 23:51:38
Document Modified: 2017-08-22 23:51:38

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		Fax written comments on the collection of information by September 22, 2017.
Contact		Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation		82 FR 40006

82 FR 40006 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 162 (August 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration