80 FR 13009 - Agency Information Collection Activities; Proposed Collection; 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 48 (March 12, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 48 (March 12, 2015)
| Page Range | 13009-13011 | |
| FR Document | 2015-05591 |
[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)] [Notices] [Pages 13009-13011] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05591] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0253] Agency Information Collection Activities; Proposed Collection; 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 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 the information collection provisions of FDA's postmarketing adverse drug experience reporting and recordkeeping requirements. DATES: Submit either electronic or written comments on the collection of information by May 11, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal [[Page 13010]] 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. 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 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. Respondents to this collection of information are manufacturers, packers, distributors, and applicants. The following estimates are based on FDA's knowledge of adverse drug experience reporting, including the time needed to prepare the reports, and the number of reports submitted to the Agency. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ \2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per 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 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. > [[Page 13011]] Table 2--Estimated Annual Recordkeeping Burden \1\ \2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number 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: March 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05591 Filed 3-11-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices 13009
COST OF REGISTRATION—Continued
July 19–
Before July After August
Affiliation August 18,
19, 2015 18, 2015
2015
Student Member ...................................................................................................................................... 280 280 280
Student Nonmember * .............................................................................................................................. 310 310 310
* For this member type, online registration is not available and must be faxed in.
Please visit PDA’s Web site: • Breakthrough Therapies DEPARTMENT OF HEALTH AND
www.pda.org/pdafda2015 to confirm • Regulatory Challenges and HUMAN SERVICES
the prevailing registration fees. (FDA Opportunities
has verified the Web site address, but • Lifecycle Management Food and Drug Administration
FDA is not responsible for any • Clinically Relevant Specifications [Docket No. FDA–2012–N–0253]
subsequent changes to the Web site after
• Food and Drug Administration
this document publishes in the Federal Agency Information Collection
Safety and Innovation Act
Register.) Activities; Proposed Collection;
If you need special accommodations • Quality Metrics/Quality Culture
Comment Request; Postmarketing
due to a disability, please contact • Manufacturing of the Future With Adverse Drug Experience Reporting
Wanda Neal (see Contact), at least 7 Submissions and Recordkeeping Biological
days in advance of the conference. • Continuous Verification and Products
Registration Instructions: To register, Validation
please submit your name, affiliation, • Continuous Manufacturing AGENCY: Food and Drug Administration,
HHS.
mailing address, telephone, fax number, • ‘‘Fishbowl’’ Role Play
and email address, along with a check ACTION: Notice.
• Quality Systems
or money order payable to ‘‘PDA.’’ Mail • Contract Manufacturing SUMMARY: The Food and Drug
to: PDA, Global Headquarters, Bethesda Organizations Administration (FDA) is announcing an
Towers, 4350 East West Hwy., Suite
• Maturity of Quality Systems opportunity for public comment on the
150, Bethesda, MD 20814. To register
via the Internet, go to PDA’s Web site: • Investigations proposed collection of certain
• Case Studies for Quality information by the Agency. Under the
www.pda.org/pdafda2015. Paperwork Reduction Act of 1995 (the
The registrar will also accept payment • Quality Submissions
PRA), Federal Agencies are required to
by major credit cards (VISA/American • Prescription Drug User Fee Act publish notice in the Federal Register
Express/MasterCard only). For more • Risk-Based Control Strategies concerning each proposed collection of
information on the meeting, or for • Supply Chain information, including each proposed
questions on registration, contact PDA • Quality Risk Management Systems extension of an existing collection of
(see Contact). • Drug Shortages information, and to allow 60 days for
Transcripts: As soon as a transcript is
available, it can be obtained in either • Customer Complaint Reviews and public comment in response to the
Trending notice. This notice solicits comments on
hardcopy or on CD–ROM, after the information collection provisions of
submission of a Freedom of Information • Human Factors
• Office of Pharmaceutical Quality FDA’s postmarketing adverse drug
request. Written requests are to be sent experience reporting and recordkeeping
to Division of Freedom of Information and Program Alignment Group
requirements.
(ELEM–1029), Food and Drug • Patient Perspective
DATES: Submit either electronic or
Administration, 12420 Parklawn Dr., • Compliance Update written comments on the collection of
Element Bldg., Rockville, MD 20857. • Center Initiatives—Regulatory information by May 11, 2015.
SUPPLEMENTARY INFORMATION: The PDA/ Submission Update ADDRESSES: Submit electronic
FDA Joint Regulatory Conference offers To help ensure the quality of FDA- comments on the collection of
the unique opportunity for participants regulated products, the workshop helps information to http://
to join FDA representatives and to achieve objectives set forth in section www.regulations.gov. Submit written
industry experts in face-to-face 406 of the FDA Modernization Act of comments on the collection of
dialogues. Each year, FDA speakers 1997 (21 U.S.C. 393), which includes information to the Division of Dockets
provide updates on current efforts working closely with stakeholders and Management (HFA 305), Food and Drug
affecting the development of global maximizing the availability and clarity Administration, 5630 Fishers Lane, Rm.
regulatory strategies, while industry of information to stakeholders and the 1061, Rockville, MD 20852. All
professionals from pharmaceutical public. The workshop also is consistent comments should be identified with the
companies present case studies on how with the Small Business Regulatory docket number found in brackets in the
they employ global strategies in their Enforcement Fairness Act of 1996 (Pub. heading of this document.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
daily processes. L. 104–121), as outreach activities by FOR FURTHER INFORMATION CONTACT: FDA
Through a series of sessions and government agencies to small
meetings, the conference will provide PRA Staff, Office of Operations, Food
businesses. and Drug Administration, 8455
participants with the opportunity to
Dated: March 4, 2015. Colesville Rd., COLE–14526, Silver
hear directly from FDA experts and
representatives of global regulatory Leslie Kux, Spring, MD 20993–0002, PRAStaff@
authorities on best practices, including: Associate Commissioner for Policy. fda.hhs.gov.
• Product Quality [FR Doc. 2015–05513 Filed 3–11–15; 8:45 am] SUPPLEMENTARY INFORMATION: Under the
• Data Integrity BILLING CODE 4164–01–P PRA (44 U.S.C. 3501–3520), Federal
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![Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices 13011
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of Number of records Total annual Average burden
21 CFR section Total hours
recordkeepers per recordkeeper records per 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: March 6, 2015. The Director, Management Analysis and ADDRESSES: Submit your comments to
Leslie Kux, Services Office, has been delegated the Information.CollectionClearance@
Associate Commissioner for Policy. authority to sign Federal Register notices hhs.gov or by calling (202) 690–6162.
pertaining to announcements of meetings and
[FR Doc. 2015–05591 Filed 3–11–15; 8:45 am] other committee management activities, for FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P both the Centers for Disease Control and Information Collection Clearance staff,
Prevention and the Agency for Toxic Information.CollectionClearance@
Substances and Disease Registry. hhs.gov or (202) 690–6162.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Elaine L. Baker, SUPPLEMENTARY INFORMATION: When
Director, Management Analysis and Services submitting comments or requesting
Centers for Disease Control and Office Centers for Disease Control and information, please include the
Prevention Prevention.
document identifier HHS–OS–0990—
[FR Doc. 2015–05575 Filed 3–11–15; 8:45 am]
New–60D for reference.
Disease, Disability, and Injury BILLING CODE 4163–18–P
Prevention and Control Special Information Collection Request Title:
Emphasis Panel (SEP): Initial Review HHS Entrepreneurs-in-Residence
DEPARTMENT OF HEALTH AND Program (EIR).
In accordance with Section 10(a)(2) of
HUMAN SERVICES Abstract: The HHS IDEA Lab, in the
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease Immediate Office of the Secretary, is
Office of the Secretary requesting an approval by Office of
Control and Prevention (CDC)
announces a meeting for the initial [Document Identifier: HHS–OS–0990—New– Management and Budget (OMB) on a
review of applications in response to 60D] new information collection, which is
DP15–007, Effectiveness of Teen critical to the success of the HHS EIR
Agency Information Collection program, and identifies private sector
Pregnancy Prevention Programs
Activities; Proposed Collection; Public entrepreneurs with unique skill sets not
Designed Specifically for Young Males.
Comment Request available in government to join HHS for
Time and Date: 9:00 a.m.—6:00 p.m., April a year to work on critical initiatives. The
7–9, 2015 (Closed). AGENCY: Office of the Secretary, HHS.
Place: Teleconference. information collection for the HHS EIR
ACTION: Notice.
Status: The meeting will be closed to the custom form management system
public in accordance with provisions set SUMMARY: In compliance with section involves obtaining candidate resumes
forth in Section 552b(c)(4) and (6), Title 5 3506(c)(2)(A) of the Paperwork and responses to short essay questions
U.S.C., and the Determination of the Director, Reduction Act of 1995, the Office of the specifically designed to determine
Management Analysis and Services Office, whether entrepreneurs have the
Secretary (OS), Department of Health
CDC, pursuant to Public Law 92–463. knowledge, skills and abilities to
Matters for Discussion: The meeting will and Human Services, announces plans
include the initial review, discussion, and to submit a new Information Collection successfully complete HHS EIR projects
evaluation of applications received in Request (ICR), described below, to the in the government context and mentor
response to ‘‘Effectiveness of Teen Pregnancy Office of Management and Budget existing government staff to acquire
Prevention Programs Designed Specifically (OMB). Prior to submitting the ICR to new, entrepreneurial skills.
for Young Males’’, DP15–007. OMB, OS seeks comments from the Likely Respondents: The candidate
Contact Person for More Information: M. public regarding the burden estimate,
Chris Langub, Ph.D., Scientific Review pools, targeted for the HHS EIR program
Officer, CDC, 4770 Buford Highway, NE., below, or any other aspect of the ICR. are serial private sector entrepreneurs
Mailstop F–80, Atlanta, Georgia 30341, DATES: Comments on the ICR must be with no prior federal government
Telephone: (770) 488–3585, EEO6@cdc.gov. received on or before May 11, 2015. experience.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
asabaliauskas on DSK5VPTVN1PROD with NOTICES
respondents response hours
respondent (in hours)
HHS EIR Application ....................................................................................... 150 1 1 150
Total .......................................................................................................... 150 1 1 150
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Document Created: 2018-02-21 09:36:05
Document Modified: 2018-02-21 09:36:05
| 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 11, 2015. | |
| 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 | 80 FR 13009 |
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