80_FR_36077 80 FR 35957 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products

80 FR 35957 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range35957-35958
FR Document2015-15319

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 80 Issue 120 (Tuesday, June 23, 2015)
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35957-35958]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15319]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0253]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Postmarketing Adverse 
Drug Experience Reporting and Recordkeeping Biological Products

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 July 
22, 2015.

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 0910-0230. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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

Postmarketing Adverse Drug Experience Reporting

OMB Control Number 0910-0230--(Extension)

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed 
drugs be safe and effective. In order to know whether drugs that are 
not safe and effective are on the market, FDA must be promptly informed 
of adverse experiences associated with the use of marketed drugs. In 
order to help ensure this, FDA issued regulations at Sec. Sec.  310.305 
and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and 
recordkeeping requirements on the drug industry that

[[Page 35958]]

would enable FDA to take the action necessary to protect the public 
health from adverse drug experiences.
    All applicants who have received marketing approval of drug 
products are required to report to FDA serious, unexpected adverse drug 
experiences (``15-day Alert reports''), as well as follow up reports 
(Sec.  314.80(c)(1)). This includes reports of all foreign or domestic 
adverse experiences as well as those based on information from 
applicable scientific literature and certain reports from postmarketing 
studies. Section 314.80(c)(1)(iii) pertains to such reports submitted 
by non-applicants.
    Under Sec.  314.80(c)(2), applicants must provide periodic reports 
of adverse drug experiences. A periodic report includes, for the 
reporting interval, reports of serious, expected adverse drug 
experiences and all nonserious adverse drug experiences and an index of 
these reports, a narrative summary and analysis of adverse drug 
experiences, an analysis of the 15-day Alert reports submitted during 
the reporting interval, and a history of actions taken because of 
adverse drug experiences. Under Sec.  314.80(i), applicants must keep 
for 10 years records of all adverse drug experience reports known to 
the applicant.
    For marketed prescription drug products without approved new drug 
applications or abbreviated new drug applications, manufacturers, 
packers, and distributors are required to report to FDA serious, 
unexpected adverse drug experiences as well as follow-up reports (Sec.  
310.305(c)). Section 310.305(c)(5) pertains to the submission of 
follow-up reports to reports forwarded to the manufacturers, packers, 
and distributors by FDA. Under Sec.  310.305(f), each manufacturer, 
packer, and distributor shall maintain for 10 years records of all 
adverse drug experiences required to be reported.
    The primary purpose of FDA's adverse drug experience reporting 
system is to enable identification of signals for potentially serious 
safety problems with marketed drugs. Although premarket testing 
discloses a general safety profile of a new drug's comparatively common 
adverse effects, the larger and more diverse patient populations 
exposed to the marketed drug provide the opportunity to collect 
information on rare, latent, and long-term effects. Signals are 
obtained from a variety of sources, including reports from patients, 
treating physicians, foreign regulatory agencies, and clinical 
investigators. Information derived from the adverse drug experience 
reporting system contributes directly to increased public health 
protection because the information enables FDA to make important 
changes to the product's labeling (such as adding a new warning), 
decisions about risk evaluation and mitigation strategies or the need 
for postmarket studies or clinical trials, and when necessary, to 
initiate removal of a drug from the market.
    In the Federal Register of March 12, 2015 (80 FR 13009), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Reporting Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   No. of        No. of responses    Total annual      Average burden
                       21 CFR section                           respondents       per respondent       responses        per response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5)..............................................                  3                  1                 3                  1                 3
314.80(c)(1)(iii)..........................................                  5                  1                 5                  1                 5
314.80(c)(2)...............................................                724              19.33            13,996                 60           839,760
                                                            --------------------------------------------------------------------------------------------
    Total..................................................  .................  .................  ................  .................           839,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec.   310.305(c)(1), (c)(2), and (c)(3), and Sec.   314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910-
  0291.
\2\ The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.


                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   No. of         No. of records     Total annual      Average burden
                       21 CFR section                          recordkeepers     per recordkeeper       records      per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f).................................................                 25                  1                25                 16               400
314.80(i)..................................................                724                508           367,959                 16         5,887,344
                                                            --------------------------------------------------------------------------------------------
    Total..................................................  .................  .................  ................  .................         5,887,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.


    Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15319 Filed 6-22-15; 8:45 am]
BILLING CODE 4164-01-P



                                                                                           Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices                                                                                                 35957

                                                  information. Two comments were                                            solicited and are therefore not addressed                                          FDA estimates the burden of this
                                                  received but neither responded to any of                                  by the Agency.                                                                   information collection as follows:
                                                  the four information collection topics

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

                                                  511.1(b)(4) .......................................................                             263                            5.30                           1,395                                  1             1,395
                                                  511.1(b)(5) .......................................................                             263                             .26                              69                                  8               552
                                                  511.1(b)(6) .......................................................                             263                             .01                               2                                  1                 2
                                                  511.1(b)(8)(ii) ...................................................                             263                             .06                              15                                  2                30
                                                  511.1(b)(9) .......................................................                             263                             .06                              15                                  8               120

                                                        Total ..........................................................    ............................    ............................     ............................    ............................            2,099
                                                     1 There    are no capital costs or operating and maintenance costs associated with this collection of information.

                                                                                                           TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
                                                                                                                                                        Number of records                                                    Average burden
                                                                                                                             Number of                                                        Total annual
                                                                     21 CFR section                                                                            per                                                                 per                       Total hours
                                                                                                                           recordkeepers                                                        records
                                                                                                                                                          recordkeeper                                                        recordkeeping

                                                  511.1(a)(3) .................................................                               263                             2.07                              545                                   1                545
                                                  511.1(b)(3) .................................................                               263                             5.30                            1,395                                   1              1,395
                                                  511.1(b)(7)(ii) .............................................                               263                             5.30                            1,395                                 3.5            4,882.5
                                                  511.1(b)(8)(i) ..............................................                               263                             5.30                            1,395                                 3.5            4,882.5

                                                        Total ....................................................    ..............................    ..............................     ............................     ..............................          11,705
                                                     1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    The estimate of the time required for                                   DEPARTMENT OF HEALTH AND                                                         comments should be identified with the
                                                  reporting requirements, record                                            HUMAN SERVICES                                                                   OMB control number 0910–0230. Also
                                                  preparation, and maintenance for this                                                                                                                      include the FDA docket number found
                                                  collection of information is based on                                     Food and Drug Administration                                                     in brackets in the heading of this
                                                  informal Agency communication with                                                                                                                         document.
                                                                                                                            [Docket No. FDA–2012–N–0253]
                                                  industry. Based on the number of                                                                                                                           FOR FURTHER INFORMATION CONTACT:    FDA
                                                  sponsors subject to animal drug user                                      Agency Information Collection                                                    PRA Staff, Office of Operations, Food
                                                  fees, FDA estimates that there are 263                                    Activities; Submission for Office of                                             and Drug Administration, 8455
                                                  respondents. We use this estimate                                         Management and Budget Review;                                                    Colesville Rd., COLE–14526, Silver
                                                  consistently throughout the table and                                     Comment Request; Postmarketing                                                   Spring, MD 20993–0002,
                                                  calculate the ‘‘annual frequency per                                      Adverse Drug Experience Reporting                                                PRAStaff@fda.hhs.gov.
                                                  respondent’’ by dividing the total                                        and Recordkeeping Biological
                                                                                                                            Products                                                                         SUPPLEMENTARY INFORMATION:    In
                                                  annual responses by number of
                                                                                                                                                                                                             compliance with 44 U.S.C. 3507, FDA
                                                  respondents. Additional information                                       AGENCY:         Food and Drug Administration,                                    has submitted the following proposed
                                                  needed to make a final calculation of the                                 HHS.                                                                             collection of information to OMB for
                                                  total burden hours (i.e., the number of                                                                                                                    review and clearance.
                                                                                                                            ACTION:        Notice.
                                                  respondents, the number of
                                                  recordkeepers, the number of NCIEs                                        SUMMARY:   The Food and Drug                                                     Postmarketing Adverse Drug
                                                  received, etc.) is derived from Agency                                    Administration (FDA) is announcing                                               Experience Reporting
                                                  records.                                                                  that a proposed collection of                                                    OMB Control Number 0910–0230—
                                                    Dated: June 17, 2015.                                                   information has been submitted to the                                            (Extension)
                                                                                                                            Office of Management and Budget
                                                  Leslie Kux,                                                                                                                                                   Sections 201, 502, 505, and 701 of the
                                                                                                                            (OMB) for review and clearance under
                                                  Associate Commissioner for Policy.                                        the Paperwork Reduction Act of 1995.                                             Federal Food, Drug, and Cosmetic Act
                                                  [FR Doc. 2015–15320 Filed 6–22–15; 8:45 am]                                                                                                                (21 U.S.C. 321, 352, 355, and 371)
                                                                                                                            DATES: Fax written comments on the
                                                  BILLING CODE 4164–01–P
                                                                                                                                                                                                             require that marketed drugs be safe and
                                                                                                                            collection of information by July 22,                                            effective. In order to know whether
                                                                                                                            2015.                                                                            drugs that are not safe and effective are
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                                            ADDRESSES:  To ensure that comments on                                           on the market, FDA must be promptly
                                                                                                                            the information collection are received,                                         informed of adverse experiences
                                                                                                                            OMB recommends that written                                                      associated with the use of marketed
                                                                                                                            comments be faxed to the Office of                                               drugs. In order to help ensure this, FDA
                                                                                                                            Information and Regulatory Affairs,                                              issued regulations at §§ 310.305 and
                                                                                                                            OMB, Attn: FDA Desk Officer, FAX:                                                314.80 (21 CFR 310.305 and 314.80) to
                                                                                                                            202–395–7285, or emailed to                                                      impose reporting and recordkeeping
                                                                                                                            oira_submission@omb.eop.gov. All                                                 requirements on the drug industry that


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                                                  35958                                    Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices

                                                  would enable FDA to take the action                                       of adverse drug experiences. Under                                             the larger and more diverse patient
                                                  necessary to protect the public health                                    § 314.80(i), applicants must keep for 10                                       populations exposed to the marketed
                                                  from adverse drug experiences.                                            years records of all adverse drug                                              drug provide the opportunity to collect
                                                     All applicants who have received                                       experience reports known to the                                                information on rare, latent, and long-
                                                  marketing approval of drug products are                                   applicant.                                                                     term effects. Signals are obtained from
                                                  required to report to FDA serious,                                           For marketed prescription drug                                              a variety of sources, including reports
                                                  unexpected adverse drug experiences                                       products without approved new drug                                             from patients, treating physicians,
                                                  (‘‘15-day Alert reports’’), as well as                                    applications or abbreviated new drug                                           foreign regulatory agencies, and clinical
                                                  follow up reports (§ 314.80(c)(1)). This                                  applications, manufacturers, packers,                                          investigators. Information derived from
                                                  includes reports of all foreign or                                        and distributors are required to report to                                     the adverse drug experience reporting
                                                  domestic adverse experiences as well as                                   FDA serious, unexpected adverse drug                                           system contributes directly to increased
                                                  those based on information from                                           experiences as well as follow-up reports                                       public health protection because the
                                                  applicable scientific literature and                                      (§ 310.305(c)). Section 310.305(c)(5)                                          information enables FDA to make
                                                  certain reports from postmarketing                                        pertains to the submission of follow-up                                        important changes to the product’s
                                                  studies. Section 314.80(c)(1)(iii) pertains                               reports to reports forwarded to the                                            labeling (such as adding a new
                                                  to such reports submitted by non-                                         manufacturers, packers, and distributors                                       warning), decisions about risk
                                                  applicants.                                                               by FDA. Under § 310.305(f), each                                               evaluation and mitigation strategies or
                                                     Under § 314.80(c)(2), applicants must                                  manufacturer, packer, and distributor                                          the need for postmarket studies or
                                                  provide periodic reports of adverse drug                                  shall maintain for 10 years records of all                                     clinical trials, and when necessary, to
                                                  experiences. A periodic report includes,                                  adverse drug experiences required to be                                        initiate removal of a drug from the
                                                  for the reporting interval, reports of                                    reported.                                                                      market.
                                                  serious, expected adverse drug                                               The primary purpose of FDA’s                                                   In the Federal Register of March 12,
                                                  experiences and all nonserious adverse                                    adverse drug experience reporting                                              2015 (80 FR 13009), FDA published a
                                                  drug experiences and an index of these                                    system is to enable identification of                                          60-day notice requesting public
                                                  reports, a narrative summary and                                          signals for potentially serious safety                                         comment on the proposed collection of
                                                  analysis of adverse drug experiences, an                                  problems with marketed drugs.                                                  information. No comments were
                                                  analysis of the 15-day Alert reports                                      Although premarket testing discloses a                                         received.
                                                  submitted during the reporting interval,                                  general safety profile of a new drug’s                                            FDA estimates the burden of this
                                                  and a history of actions taken because                                    comparatively common adverse effects,                                          collection of information as follows:

                                                                                                              TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
                                                                                                                                                                No. of                                                           Average
                                                                                                                             No. of                                                         Total annual
                                                                     21 CFR section                                                                        responses per                                                       burden per                 Total hours
                                                                                                                          respondents                                                        responses
                                                                                                                                                             respondent                                                         response

                                                  310.305(c)(5) ..............................................                                  3                                1                             3                                   1                  3
                                                  314.80(c)(1)(iii) ...........................................                                 5                                1                             5                                   1                  5
                                                  314.80(c)(2) ................................................                               724                            19.33                        13,996                                  60            839,760

                                                        Total ....................................................    ..............................    ..............................   ............................    ..............................         839,768
                                                     1 The reporting burden for § 310.305(c)(1), (c)(2), and (c)(3), and § 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910–0291.
                                                     2 The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.



                                                                                                         TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
                                                                                                                                                                                                                               Average
                                                                                                                             No. of                     No. of records per                  Total annual
                                                                     21 CFR section                                                                                                                                           burden per                  Total hours
                                                                                                                         recordkeepers                    recordkeeper                        records                       recordkeeping

                                                  310.305(f) ...................................................                               25                                 1                          25                                   16                400
                                                  314.80(i) .....................................................                             724                               508                     367,959                                   16          5,887,344

                                                        Total ....................................................    ..............................    ..............................   ............................    ..............................       5,887,744
                                                     1 There    are no capital costs or operating costs associated with this collection of information.
                                                     2 There    are maintenance costs of approximately $22,000 annually.


                                                    Dated: June 17, 2015.
                                                  Leslie Kux,
                                                  Associate Commissioner for Policy.
                                                  [FR Doc. 2015–15319 Filed 6–22–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  BILLING CODE 4164–01–P




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Document Created: 2018-02-22 11:15:34
Document Modified: 2018-02-22 11:15:34
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.
DatesFax written comments on the collection of information by July 22, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 35957 

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