82 FR 28074 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 117 (June 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 117 (June 20, 2017)
| Page Range | 28074-28075 | |
| FR Document | 2017-12782 |
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)] [Notices] [Pages 28074-28075] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12782] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1496] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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) 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 20, 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 0910-0500. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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. 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-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 1003(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. In the Federal Register of January 13, 2017 (82 FR 4354), 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: [[Page 28075]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Rapid Response Survey................... 10,000 6 60,000 0.5 (30 minutes).......................... 30,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 14, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12782 Filed 6-19-17; 8:45 am] BILLING CODE 4164-01-P
![28074 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of Total
No. of responses Hours per
annual Total hours
respondents per response
responses
respondent
PFC ...................................................................................... 125 2.20 275 32 8,800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access FOR FURTHER INFORMATION CONTACT: notification and review process. FDA’s
Amber Sanford, Office of Operations, regulations governing application for
Persons with access to the Internet
Food and Drug Administration, Three Agency approval to market a new drug
may obtain the draft guidance at either
White Flint North, 10A63, 11601 (21 CFR part 314) and regulations
https://www.fda.gov/Drugs/Guidance
Landsdown St., North Bethesda, MD governing biological products (21 CFR
ComplianceRegulatoryInformation/
20852, 301–796–8867, PRAStaff@ part 600) implement these statutory
Guidances/default.htm or https://
fda.hhs.gov. provisions. Currently, FDA monitors
www.regulations.gov.
SUPPLEMENTARY INFORMATION: In medical product related postmarket
Dated: June 15, 2017. adverse events via both the mandatory
compliance with 44 U.S.C. 3507, FDA
Anna K. Abram, has submitted the following proposed and voluntary MedWatch reporting
Deputy Commissioner for Policy, Planning, collection of information to OMB for systems using FDA Forms 3500 and
Legislation, and Analysis. review and clearance. 3500A (OMB control number 0910–
[FR Doc. 2017–12836 Filed 6–19–17; 8:45 am] 0291) and the vaccine adverse event
BILLING CODE 4164–01–P
FDA Rapid Response Surveys (Generic reporting system.
Collection) FDA is seeking OMB clearance to
OMB Control Number 0910–0500— collect vital information via a series of
DEPARTMENT OF HEALTH AND Extension rapid response surveys. Participation in
HUMAN SERVICES these surveys will be voluntary. This
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 request covers rapid response surveys
Food and Drug Administration for community based health care
U.S.C. 355) requires that important
safety information relating to all human professionals, general type medical
[Docket No. FDA–2013–N–1496] facilities, specialized medical facilities
prescription drug products be made
available to FDA so that it can take (those known for cardiac surgery,
Agency Information Collection obstetrics/gynecology services, pediatric
Activities; Submission for Office of appropriate action to protect the public
health when necessary. Section 702 of services, etc.), other health care
Management and Budget Review; professionals, patients, consumers, and
Comment Request; Food and Drug the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for risk managers working in medical
Administration Rapid Response facilities. FDA will use the information
Surveys (Generic Clearance) enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C. gathered from these surveys to quickly
AGENCY: Food and Drug Administration, 360i), FDA is authorized to require obtain vital information about medical
HHS. manufacturers to report medical device- product risks and interventions to
related deaths, serious injuries, and reduce risks so the Agency may take
ACTION: Notice. appropriate public health or regulatory
malfunctions to FDA; to require user
SUMMARY: The Food and Drug facilities to report device-related deaths action including dissemination of this
Administration (FDA) is announcing directly to FDA and to manufacturers; information as necessary and
that a proposed collection of and to report serious injuries to the appropriate.
information has been submitted to the manufacturer. Section 522 of the FD&C FDA projects 6 emergency risk related
Office of Management and Budget Act (21 U.S.C. 360l) authorizes FDA to surveys per year with a sample of
(OMB) for review and clearance under require manufacturers to conduct between 50 and 10,000 respondents per
the Paperwork Reduction Act of 1995. postmarket surveillance of medical survey. FDA also projects a response
devices. Section 705(b) of the FD&C Act time of 0.5 hour per response. These
DATES: Fax written comments on the
(21 U.S.C. 375(b)) authorizes FDA to estimates are based on the maximum
collection of information by July 20, sample size per questionnaire that FDA
collect and disseminate information
2017. may be able to obtain by working with
regarding medical products or cosmetics
ADDRESSES: To ensure that comments on in situations involving imminent danger health care professional organizations.
the information collection are received, to health or gross deception of the The annual number of surveys was
OMB recommends that written consumer. Section 1003(d)(2) of the determined by the maximum number of
comments be faxed to the Office of FD&C Act (21 U.S.C. 393(d)(2)) surveys per year FDA has ever
Information and Regulatory Affairs, authorizes the Commissioner of Food conducted under this collection.
OMB, Attn: FDA Desk Officer, FAX: and Drugs to implement general powers In the Federal Register of January 13,
sradovich on DSK3GMQ082PROD with NOTICES
202–395–7285, or emailed to oira_ (including conducting research) to carry 2017 (82 FR 4354), FDA published a 60-
submission@omb.eop.gov. All out effectively the mission of FDA. day notice requesting public comment
comments should be identified with the These sections of the FD&C Act enable on the proposed collection of
OMB control number 0910–0500. Also FDA to enhance consumer protection information. No comments were
include the FDA docket number found from risks associated with medical received.
in brackets in the heading of this products usage that are not foreseen or FDA estimates the burden of this
document. apparent during the premarket collection of information as follows:
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![Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices 28075
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses
Activity annual burden per Total hours
respondents per responses response
respondent
FDA Rapid Response Survey .................................. 10,000 6 60,000 0.5 (30 minutes) ........ 30,000
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 14, 2017. service acceptance receipt is on or Submissions,’’ publicly viewable at
Anna K. Abram, before that date. https://www.regulations.gov or at the
Deputy Commissioner for Policy, Planning, Dockets Management Staff between 9
Electronic Submissions
Legislation, and Analysis. a.m. and 4 p.m., Monday through
[FR Doc. 2017–12782 Filed 6–19–17; 8:45 am] Submit electronic comments in the Friday.
BILLING CODE 4164–01–P
following way: • Confidential Submissions—To
• Federal eRulemaking Portal:
submit a comment with confidential
https://www.regulations.gov. Follow the
information that you do not wish to be
DEPARTMENT OF HEALTH AND instructions for submitting comments.
Comments submitted electronically, made publicly available, submit your
HUMAN SERVICES comments only as a written/paper
including attachments, to https://
www.regulations.gov will be posted to submission. You should submit two
Food and Drug Administration copies total. One copy will include the
the docket unchanged. Because your
comment will be made public, you are information you claim to be confidential
[Docket No. FDA–2014–N–1072] with a heading or cover note that states
solely responsible for ensuring that your
comment does not include any ‘‘THIS DOCUMENT CONTAINS
Agency Information Collection
confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
Activities; Proposed Collection;
third party may not wish to be posted, Agency will review this copy, including
Comment Request; Application for
such as medical information, your or the claimed confidential information, in
Participation in Food and Drug
anyone else’s Social Security number, or its consideration of comments. The
Administration Fellowship Programs
confidential business information, such second copy, which will have the
AGENCY: Food and Drug Administration, as a manufacturing process. Please note claimed confidential information
HHS. that if you include your name, contact redacted/blacked out, will be available
ACTION: Notice. information, or other information that for public viewing and posted on
identifies you in the body of your https://www.regulations.gov. Submit
SUMMARY: The Food and Drug comments, that information will be both copies to the Dockets Management
Administration (FDA or Agency) is posted on https://www.regulations.gov. Staff. If you do not wish your name and
announcing an opportunity for public • If you want to submit a comment contact information to be made publicly
comment on the proposed collection of with confidential information that you available, you can provide this
certain information by the Agency. do not wish to be made available to the information on the cover sheet and not
Under the Paperwork Reduction Act of public, submit the comment as a in the body of your comments and you
1995 (PRA), Federal Agencies are written/paper submission and in the must identify this information as
required to publish notice in the manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
Federal Register concerning each Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
proposed collection of information, except in accordance with 21 CFR 10.20
including each proposed extension of an Written/Paper Submissions and other applicable disclosure law. For
existing collection of information, and Submit written/paper submissions as more information about FDA’s posting
to allow 60 days for public comment in follows: of comments to public dockets, see 80
response to the notice. This notice • Mail/Hand delivery/Courier (for FR 56469, September 18, 2015, or access
solicits comments on ‘‘Application for written/paper submissions): Dockets the information at: https://www.gpo.gov/
Participation in FDA Fellowship Management Staff (HFA–305), Food and fdsys/pkg/FR-2015-09-18/pdf/2015-
Programs.’’ Drug Administration, 5630 Fishers 23389.pdf.
Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to
DATES: Submit either electronic or • For written/paper comments
written comments on the collection of read background documents or the
submitted to the Dockets Management
information by August 21, 2017. electronic and written/paper comments
Staff, FDA will post your comment, as
ADDRESSES: You may submit comments
received, go to https://
well as any attachments, except for
as follows. Please note that late, www.regulations.gov and insert the
information submitted, marked and
untimely filed comments will not be docket number, found in brackets in the
identified, as confidential, if submitted
considered. Electronic comments must heading of this document, into the
as detailed in ‘‘Instructions.’’
be submitted on or before August 21, Instructions: All submissions received ‘‘Search’’ box and follow the prompts
2017. The https://www.regulations.gov must include the Docket No. FDA– and/or go to the Dockets Management
sradovich on DSK3GMQ082PROD with NOTICES
electronic filing system will accept 2014–N–1072 for ‘‘Application for Staff, 5630 Fishers Lane, Rm. 1061,
comments until midnight Eastern Time Participation in Food and Drug Rockville, MD 20852.
at the end of August 21, 2017. Administration Fellowship Programs.’’ FOR FURTHER INFORMATION CONTACT:
Comments received by mail/hand Received comments, those filed in a Amber Sanford, Office of Operations,
delivery/courier (for written/paper timely manner (see ADDRESSES), will be Food and Drug Administration, Three
submissions) will be considered timely placed in the docket and, except for White Flint North, 10A63, 11601
if they are postmarked or the delivery those submitted as ‘‘Confidential Landsdown St., North Bethesda, MD
VerDate Sep<11>2014 18:01 Jun 19, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\20JNN1.SGM 20JNN1](https://thefederalregister.org/doc/82_FR_28191/page/2.svg)
Document Created: 2017-06-20 02:20:53
Document Modified: 2017-06-20 02:20:53
| 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 July 20, 2017. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 28074 |
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