82 FR 4354 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 9 (January 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4354-4356 | |
| FR Document | 2017-00632 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4354-4356] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00632] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1496] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) 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 [[Page 4355]] 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 use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health. DATES: Submit either electronic or written comments on the collection of information by March 14, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-1496 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance).'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 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 https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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. FDA Rapid Response Surveys (Generic Collection), OMB Control Number 0910-0500--Extension Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355), requires that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&C Act. Under section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to require manufacturers to report medical device- [[Page 4356]] related deaths, serious injuries, and malfunctions to FDA; to require user facilities to report device-related deaths directly to FDA and to manufacturers; and to report serious injuries to the manufacturer. Section 522 of the FD&C Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the FD&C Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health or gross deception of the consumer. Section 903(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the Commissioner of Food and Drugs to implement general powers (including conducting research) to carry out effectively the mission of FDA. These sections of the FD&C Act enable FDA to enhance consumer protection from risks associated with medical products usage that are not foreseen or apparent during the premarket notification and review process. FDA's regulations governing application for Agency approval to market a new drug (21 CFR part 314) and regulations governing biological products (21 CFR part 600) implement these statutory provisions. Currently, FDA monitors medical product related postmarket adverse events via both the mandatory and voluntary MedWatch reporting systems using FDA Forms 3500 and 3500A (OMB control number 0910-0291) and the vaccine adverse event reporting system. FDA is seeking OMB clearance to collect vital information via a series of rapid response surveys. Participation in these surveys will be voluntary. This request covers rapid response surveys for community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers, and risk managers working in medical facilities. FDA will use the information gathered from these surveys to quickly obtain vital information about medical product risks and interventions to reduce risks so the Agency may take appropriate public health or regulatory action including dissemination of this information as necessary and appropriate. FDA projects 6 emergency risk related surveys per year with a sample of between 50 and 10,000 respondents per survey. FDA also projects a response time of 0.5 hour per response. These estimates are based on the maximum sample size per questionnaire that FDA may be able to obtain by working with health care professional organizations. The annual number of surveys was determined by the maximum number of surveys per year FDA has ever conducted under this collection. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Rapid Response Survey.......................................... 10,000 6 60,000 0.5 30,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00632 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
![4354 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
submission. You should submit two Evaluation and Research, Food and sources of multiplicity, including
copies total. One copy will include the Drug Administration, 10903 New multiple doses, time points, or study
information you claim to be confidential Hampshire Ave., Bldg. 71, Rm. 7301, population subgroups.
with a heading or cover note that states Silver Spring, MD 20993–0002, 240– Once a trial is successful
‘‘THIS DOCUMENT CONTAINS 402–7911. (demonstrates effectiveness or ‘‘wins’’
CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION: on the primary endpoint(s)), there are
Agency will review this copy, including many other attributes of a drug’s effects
the claimed confidential information, in I. Background that may be described. Analyses that
its consideration of comments. The FDA is announcing the availability of describe these other attributes of a drug
second copy, which will have the a draft guidance for industry entitled can be informative and are often
claimed confidential information ‘‘Multiple Endpoints in Clinical Trials.’’ included in physician labeling. Such
redacted/blacked out, will be available This guidance describes various descriptive analyses are not the subject
for public viewing and posted on http:// strategies for grouping and ordering of this draft guidance and are not
www.regulations.gov. Submit both endpoints for analysis and applying addressed in detail.
copies to the Division of Dockets some well-recognized statistical This draft guidance is being issued
Management. If you do not wish your methods for managing multiplicity consistent with FDA’s good guidance
name and contact information to be within a study. FDA’s International practices regulation (21 CFR 10.115).
made publicly available, you can Conference on Harmonization (ICH) The draft guidance, when finalized, will
provide this information on the cover guidance for industry ‘‘E9 Statistical represent the current thinking of FDA
sheet and not in the body of your Principles for Clinical Trials’’ is a broad- on multiple endpoints in clinical trials.
comments and you must identify this ranging guidance that includes It does not establish any rights for any
information as ‘‘confidential.’’ Any discussion of multiple endpoints. This person and is not binding on FDA or the
information marked as ‘‘confidential’’ draft guidance provides greater detail on public. You can use an alternative
will not be disclosed except in the topic of multiple endpoints. The approach if it satisfies the requirements
accordance with 21 CFR 10.20 and other issuance of this draft guidance of the applicable statutes and
applicable disclosure law. For more represents partial fulfillment of an FDA regulations.
information about FDA’s posting of commitment under the Food and Drug
II. Electronic Access
comments to public dockets, see 80 FR Administration Amendments Act of
2007. (Title I of the Food and Drug Persons with access to the Internet
56469, September 18, 2015, or access
Administration Amendments Act of may obtain the draft guidance at either
the information at: http://www.fda.gov/
2007 (Pub. L. 110–85)). Under section XI http://www.fda.gov/Drugs/Guidance
regulatoryinformation/dockets/
(Expediting Drug Development) of the ComplianceRegulatoryInformation/
default.htm.
Prescription Drug User Fee Act Guidances/default.htm, http://
Docket: For access to the docket to
(PDUFA) Performance Goals, FDA www.fda.gov/BiologicsBloodVaccines/
read background documents or the
agreed to develop and publish for GuidanceComplianceRegulatory
electronic and written/paper comments
comment draft guidance on ‘‘Multiple Information/Guidances/default.htm, or
received, go to http://
Endpoints in Clinical Trials,’’ and to http://www.regulations.gov.
www.regulations.gov and insert the
docket number, found in brackets in the complete the final guidance within one Dated: January 10, 2017.
heading of this document, into the year of the close of the public comment Leslie Kux,
‘‘Search’’ box and follow the prompts period of the PDUFA Performance Goals Associate Commissioner for Policy.
and/or go to the Division of Dockets (see http://www.fda.gov/ForIndustry/
[FR Doc. 2017–00695 Filed 1–12–17; 8:45 am]
Management, 5630 Fishers Lane, Rm. UserFees/PrescriptionDrugUserFee/
BILLING CODE 4164–01–P
ucm119243.htm).
1061, Rockville, MD 20852.
Failure to account for multiplicity
Submit written requests for single
when there are several clinical
copies of the draft guidance to the DEPARTMENT OF HEALTH AND
endpoints evaluated in a study can lead
Division of Drug Information, Center for HUMAN SERVICES
to false positive conclusions regarding
Drug Evaluation and Research, Food the effects of the drug. The regulatory
and Drug Administration, 10001 New Food and Drug Administration
concern regarding multiplicity arises
Hampshire Ave., Hillandale Building, principally in the evaluation of clinical [Docket No. FDA–2013–N–1496]
4th Floor, Silver Spring, MD 20993– trials intended to demonstrate
0002; or the Office of Communication, effectiveness and support drug Agency Information Collection
Outreach and Development, Center for approval; however, this issue is Activities; Proposed Collection;
Biologics Evaluation and Research, important throughout the drug Comment Request; Food and Drug
Food and Drug Administration, 10903 development process. Administration Rapid Response
New Hampshire Ave., Bldg. 71, Rm. The focus of this draft guidance is Surveys (Generic Clearance)
3128, Silver Spring, MD 20993–0002. control of the Type 1 error rate for the AGENCY: Food and Drug Administration,
Send one self-addressed adhesive label planned primary and secondary HHS.
to assist that office in processing your endpoints of a clinical trial so that the
requests. See the SUPPLEMENTARY ACTION: Notice.
major findings are well supported.
INFORMATION section for electronic Multiplicity adjustments provide a SUMMARY: The Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
access to the draft guidance document. means for controlling Type 1 error when Administration (FDA or Agency) is
FOR FURTHER INFORMATION CONTACT: there are multiple analyses of the drug’s announcing an opportunity for public
Scott Goldie, Center for Drug Evaluation effects. The issues of multiplicity and comment on the proposed collection of
and Research, Food and Drug methods to address them are illustrated certain information by the Agency.
Administration, 10903 New Hampshire in the draft guidance with examples of Under the Paperwork Reduction Act of
Ave., Bldg. 21, Rm. 3557, Silver Spring, different study endpoints. Both the 1995 (the PRA), Federal Agencies are
MD 20993–0002, 301–796–2055; or issues and methods that apply to required to publish notice in the
Stephen Ripley, Center for Biologics multiple endpoints also apply to other Federal Register concerning each
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![4356 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
related deaths, serious injuries, and notification and review process. FDA’s risk managers working in medical
malfunctions to FDA; to require user regulations governing application for facilities. FDA will use the information
facilities to report device-related deaths Agency approval to market a new drug gathered from these surveys to quickly
directly to FDA and to manufacturers; (21 CFR part 314) and regulations obtain vital information about medical
and to report serious injuries to the governing biological products (21 CFR product risks and interventions to
manufacturer. Section 522 of the FD&C part 600) implement these statutory reduce risks so the Agency may take
Act (21 U.S.C. 360l) authorizes FDA to provisions. Currently, FDA monitors appropriate public health or regulatory
require manufacturers to conduct medical product related postmarket action including dissemination of this
postmarket surveillance of medical adverse events via both the mandatory information as necessary and
devices. Section 705(b) of the FD&C Act and voluntary MedWatch reporting appropriate.
(21 U.S.C. 375(b)) authorizes FDA to systems using FDA Forms 3500 and
FDA projects 6 emergency risk related
collect and disseminate information 3500A (OMB control number 0910–
surveys per year with a sample of
regarding medical products or cosmetics 0291) and the vaccine adverse event
in situations involving imminent danger between 50 and 10,000 respondents per
reporting system.
to health or gross deception of the FDA is seeking OMB clearance to survey. FDA also projects a response
consumer. Section 903(d)(2) of the collect vital information via a series of time of 0.5 hour per response. These
FD&C Act (21 U.S.C. 393(d)(2)) rapid response surveys. Participation in estimates are based on the maximum
authorizes the Commissioner of Food these surveys will be voluntary. This sample size per questionnaire that FDA
and Drugs to implement general powers request covers rapid response surveys may be able to obtain by working with
(including conducting research) to carry for community based health care health care professional organizations.
out effectively the mission of FDA. professionals, general type medical The annual number of surveys was
These sections of the FD&C Act enable facilities, specialized medical facilities determined by the maximum number of
FDA to enhance consumer protection (those known for cardiac surgery, surveys per year FDA has ever
from risks associated with medical obstetrics/gynecology services, pediatric conducted under this collection.
products usage that are not foreseen or services, etc.), other health care FDA estimates the burden of this
apparent during the premarket professionals, patients, consumers, and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
FDA Rapid Response Survey .............................................. 10,000 6 60,000 0.5 30,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 9, 2017. Investigational Device Exemptions.’’ solely responsible for ensuring that your
Leslie Kux, The purpose of this guidance is to comment does not include any
Associate Commissioner for Policy. provide greater clarity for FDA staff and confidential information that you or a
[FR Doc. 2017–00632 Filed 1–12–17; 8:45 am] Investigational Device Exemptions (IDE) third party may not wish to be posted,
BILLING CODE 4164–01–P
application sponsors and sponsor- such as medical information, your or
investigators regarding the principal anyone else’s Social Security number, or
factors that the Agency considers when confidential business information, such
DEPARTMENT OF HEALTH AND assessing the benefits and risks of IDE as a manufacturing process. Please note
HUMAN SERVICES applications for human clinical study. that if you include your name, contact
The guidance also characterizes benefits information, or other information that
Food and Drug Administration in the context of investigational identifies you in the body of your
research, which includes direct benefits comments, that information will be
[Docket No. FDA–2015–D–1777] to the subjects and benefits to others. posted on http://www.regulations.gov.
DATES: Submit either electronic or • If you want to submit a comment
Factors To Consider When Making with confidential information that you
written comments on this guidance at
Benefit-Risk Determinations for do not wish to be made available to the
any time. General comments on Agency
Medical Device Investigational Device public, submit the comment as a
guidance documents are welcome at any
Exemptions; Guidance for written/paper submission and in the
time.
Investigational Device Exemption manner detailed (see ‘‘Written/Paper
Sponsors, Sponsor-Investigators, and ADDRESSES: You may submit comments
as follows: Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration Staff;
Availability Electronic Submissions Written/Paper Submissions
AGENCY: Food and Drug Administration, Submit electronic comments in the Submit written/paper submissions as
HHS. following way: follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION: Notice of availability. • Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for
www.regulations.gov. Follow the written/paper submissions): Division of
SUMMARY: The Food and Drug instructions for submitting comments. Dockets Management (HFA–305), Food
Administration (FDA or Agency) is Comments submitted electronically, and Drug Administration, 5630 Fishers
announcing the availability of the including attachments, to http:// Lane, Rm. 1061, Rockville, MD 20852.
guidance entitled ‘‘Factors to Consider www.regulations.gov will be posted to • For written/paper comments
When Making Benefit-Risk the docket unchanged. Because your submitted to the Division of Dockets
Determinations for Medical Device comment will be made public, you are Management, FDA will post your
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Document Created: 2017-01-13 02:45:23
Document Modified: 2017-01-13 02:45:23
| 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 March 14, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 4354 |
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