82 FR 39792 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 161 (August 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 161 (August 22, 2017)
| Page Range | 39792-39793 | |
| FR Document | 2017-17702 |
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)] [Notices] [Pages 39792-39793] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17702] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0062] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 21, 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 0910-0586. 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. Medical Devices; Exception From General Requirements for Informed Consent OMB Control Number 0910-0586--Extension In the Federal Register of June 7, 2006 (71 FR 32827), FDA issued an interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The Agency took this action because it was concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. Section 50.23(e)(1) (21 CFR 50.23(e)(1)) provides an exception to the general rule that informed consent is required for the use of an investigational in vitro diagnostic device. This exception applies to those situations in which the in vitro investigational diagnostic device is used to prepare for, and respond to, a chemical, biological, radiological, or nuclear terrorism event or other public health emergency, if the investigator and an independent licensed physician make the determination and later certify in writing that: (1) There is a life-threatening situation necessitating the use of the investigational device, (2) obtaining informed consent from the subject is not feasible because there was no way to predict the need to use the investigational device when the specimen was collected and there is not sufficient time to obtain consent from the subject or the subject's legally authorized representative, and (3) no satisfactory alternative device is available. Under the rule, these determinations are made before the device is used, and the written certifications are made within 5 working days after the use of the device. If use of the device is necessary to preserve the life of the subject and there is not sufficient time to obtain the determination of the independent licensed physician in advance of using the investigational device, Sec. 50.23(e)(2) provides that the certifications must be made within 5 working days of use of the device. In either case, the certifications are submitted to the Institutional Review Board (IRB) and, under Sec. 50.23(e)(3) (76 FR 36989, June 24, 2011), to FDA within 5 working days of the use of the device. Section 50.23(e)(4) provides that an investigator must disclose the investigational status of the device and what is known about the performance characteristics of the device at the time test results are reported to the subject's health care provider and public health authorities, as applicable. Under Sec. 50.23(e)(4), the investigator provides the IRB with the information required by Sec. 50.25 (21 CFR 50.25) (except for the information described in Sec. 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative. FDA estimates that there are approximately 150 laboratories that could perform testing that uses investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents. FDA estimates that in the United States each year there are approximately 450 [[Page 39793]] naturally occurring cases of diseases or conditions that are identified in the Centers for Disease Control and Prevention's list of category ``A'' biological threat agents. The number of cases that would result from a terrorist event or other public health emergency is uncertain. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 2 hours to prepare each certification. We estimate the operating and maintenance cost of $200 for copying and mailing the information to FDA. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 1 hour to prepare a report disclosing the investigational status of the in vitro diagnostic device and what is known about the performance characteristics of the device and submit it to the health care provider and, where appropriate, to public health authorities. In the Federal Register of April 18, 2017 (82 FR 18294), 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average burden per operating and 21 CFR section respondents responses per responses response Total hours maintenance respondent costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Written certification (sent to FDA)-- 150 3 450 0.25 (15 minutes).......... 113 $200 50.23(e)(3). -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of disclosures Total annual Average 21 CFR Part respondents per disclosures burden per Total hours respondent disclosure ---------------------------------------------------------------------------------------------------------------- Written certification (sent to 150 3 450 2 900 IRB)--50.23(e)(1) and (2)...... Informed consent information-- 150 3 450 1 450 50.23(e)(4).................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,350 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17702 Filed 8-21-17; 8:45 am] BILLING CODE 4164-01-P
![39792 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
proposed participants, and an of information has been submitted to the Section 50.23(e)(1) (21 CFR
indication of the approximate time Office of Management and Budget 50.23(e)(1)) provides an exception to the
requested to make their presentation on (OMB) for review and clearance under general rule that informed consent is
or before August 25, 2017. Time allotted the Paperwork Reduction Act of 1995. required for the use of an investigational
for each presentation may be limited. If DATES: Fax written comments on the in vitro diagnostic device. This
the number of registrants requesting to collection of information by September exception applies to those situations in
speak is greater than can be reasonably 21, 2017. which the in vitro investigational
accommodated during the scheduled ADDRESSES: To ensure that comments on diagnostic device is used to prepare for,
open public hearing session, FDA may the information collection are received, and respond to, a chemical, biological,
conduct a lottery to determine the OMB recommends that written radiological, or nuclear terrorism event
speakers for the scheduled open public comments be faxed to the Office of or other public health emergency, if the
hearing session. The contact person will Information and Regulatory Affairs, investigator and an independent
notify interested persons regarding their OMB, Attn: FDA Desk Officer, Fax: 202– licensed physician make the
request to speak by August 28, 2017. 395–7285, or emailed to oira_ determination and later certify in
Persons attending FDA’s advisory submission@omb.eop.gov. All writing that: (1) There is a life-
committee meetings are advised that the comments should be identified with the threatening situation necessitating the
Agency is not responsible for providing OMB control number 0910–0586. Also use of the investigational device, (2)
access to electrical outlets. include the FDA docket number found obtaining informed consent from the
For press inquiries, please contact the in brackets in the heading of this subject is not feasible because there was
Office of Media Affairs at fdaoma@ document. no way to predict the need to use the
fda.hhs.gov or 301–796–4540. investigational device when the
FOR FURTHER INFORMATION CONTACT:
FDA welcomes the attendance of the specimen was collected and there is not
Amber Sanford, Office of Operations, sufficient time to obtain consent from
public at its advisory committee Food and Drug Administration, Three
meetings and will make every effort to the subject or the subject’s legally
White Flint North 10A63, 11601 authorized representative, and (3) no
accommodate persons with disabilities. Landsdown St., North Bethesda, MD
If you require accommodations due to a satisfactory alternative device is
20852, 301–796–8867, PRAStaff@ available. Under the rule, these
disability, please contact Marieann Brill fda.hhs.gov.
at least 7 days in advance of the determinations are made before the
meeting. SUPPLEMENTARY INFORMATION: In device is used, and the written
FDA is committed to the orderly compliance with 44 U.S.C. 3507, FDA certifications are made within 5 working
conduct of its advisory committee has submitted the following proposed days after the use of the device. If use
meetings. Please visit our Web site at collection of information to OMB for of the device is necessary to preserve
http://www.fda.gov/ review and clearance. the life of the subject and there is not
AdvisoryCommittees/ Medical Devices; Exception From sufficient time to obtain the
AboutAdvisoryCommittees/ General Requirements for Informed determination of the independent
ucm111462.htm for procedures on Consent OMB Control Number 0910– licensed physician in advance of using
public conduct during advisory 0586—Extension the investigational device, § 50.23(e)(2)
committee meetings. provides that the certifications must be
In the Federal Register of June 7, 2006 made within 5 working days of use of
Notice of this meeting is given under (71 FR 32827), FDA issued an interim
the Federal Advisory Committee Act (5 the device. In either case, the
final rule to amend its regulations to certifications are submitted to the
U.S.C. app. 2). establish a new exception from the Institutional Review Board (IRB) and,
Dated: August 17, 2017. general requirements for informed under § 50.23(e)(3) (76 FR 36989, June
Leslie Kux, consent, to permit the use of 24, 2011), to FDA within 5 working days
Associate Commissioner for Policy. investigational in vitro diagnostic of the use of the device.
[FR Doc. 2017–17726 Filed 8–21–17; 8:45 am] devices to identify chemical, biological, Section 50.23(e)(4) provides that an
BILLING CODE 4164–01–P
radiological, or nuclear agents without investigator must disclose the
informed consent in certain investigational status of the device and
circumstances. The Agency took this what is known about the performance
DEPARTMENT OF HEALTH AND action because it was concerned that, characteristics of the device at the time
HUMAN SERVICES during a potential terrorism event or test results are reported to the subject’s
other potential public health emergency, health care provider and public health
Food and Drug Administration delaying the testing of specimens to authorities, as applicable. Under
obtain informed consent may threaten § 50.23(e)(4), the investigator provides
[Docket No. FDA–2010–N–0062] the life of the subject. In many the IRB with the information required
instances, there may also be others who by § 50.25 (21 CFR 50.25) (except for the
Agency Information Collection
have been exposed to, or who may be information described in § 50.25(a)(8))
Activities; Submission for Office of
at risk of exposure to, a dangerous and the procedures that will be used to
Management and Budget Review;
chemical, biological, radiological, or provide this information to each subject
Comment Request; Medical Devices;
nuclear agent, thus necessitating or the subject’s legally authorized
Exception From General Requirements
identification of the agent as soon as representative.
for Informed Consent
possible. FDA created this exception to
sradovich on DSK3GMQ082PROD with NOTICES
FDA estimates that there are
AGENCY: Food and Drug Administration, help ensure that individuals who may approximately 150 laboratories that
HHS. have been exposed to a chemical, could perform testing that uses
ACTION: Notice. biological, radiological, or nuclear agent investigational in vitro diagnostic
are able to benefit from the timely use devices to identify chemical, biological,
SUMMARY: The Food and Drug of the most appropriate diagnostic radiological, or nuclear agents. FDA
Administration (FDA or the Agency) is devices, including those that are estimates that in the United States each
announcing that a proposed collection investigational. year there are approximately 450
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![Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39793
naturally occurring cases of diseases or estimate the operating and maintenance provider and, where appropriate, to
conditions that are identified in the cost of $200 for copying and mailing the public health authorities.
Centers for Disease Control and information to FDA. In the Federal Register of April 18,
Prevention’s list of category ‘‘A’’ Based on its knowledge of similar
2017 (82 FR 18294), FDA published a
biological threat agents. The number of types of submissions, FDA estimates
60-day notice requesting public
cases that would result from a terrorist that it will take about 1 hour to prepare
comment on the proposed collection of
event or other public health emergency a report disclosing the investigational
is uncertain. Based on its knowledge of status of the in vitro diagnostic device information. No comments were
similar types of submissions, FDA and what is known about the received.
estimates that it will take about 2 hours performance characteristics of the FDA estimates the burden of this
to prepare each certification. We device and submit it to the health care collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
Number of
Number of Total annual Average burden per operating and
21 CFR section responses per Total hours
respondents responses response maintenance
respondent costs
Written certification (sent to 150 3 450 0.25 (15 minutes) ............... 113 $200
FDA)—50.23(e)(3).
1 There are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR Part burden per Total hours
respondents per disclosures disclosure
respondent
Written certification (sent to IRB)—50.23(e)(1) and (2) ...... 150 3 450 2 900
Informed consent information—50.23(e)(4) ......................... 150 3 450 1 450
Total .............................................................................. ........................ ........................ ........................ ........................ 1,350
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 17, 2017. (OMB) for review and clearance under SUPPLEMENTARY INFORMATION: In
Leslie Kux, the Paperwork Reduction Act of 1995. compliance with 44 U.S.C. 3507, FDA
Associate Commissioner for Policy. has submitted the following proposed
DATES: Fax written comments on the collection of information to OMB for
[FR Doc. 2017–17702 Filed 8–21–17; 8:45 am]
collection of information by September review and clearance.
BILLING CODE 4164–01–P
21, 2017.
Submission of Petitions: Food
ADDRESSES: To ensure that comments on Additive, Color Additive (Including
DEPARTMENT OF HEALTH AND the information collection are received, Labeling), Submission of Information to
HUMAN SERVICES OMB recommends that written a Master File in Support of Petitions;
comments be faxed to the Office of and Electronic Submission Using Food
Food and Drug Administration Information and Regulatory Affairs, and Drug Administration Form 3503—
OMB, Attn: FDA Desk Officer, Fax: 202– 21 CFR 70.25, 71.1, and 171.1, and 21
[Docket No. FDA–2010–N–0258] CFR parts 172, 173, 179, and 180; OMB
395–7285, or emailed to oira_
submission@omb.eop.gov. All Control Number 0910–0016—Extension.
Agency Information Collection
comments should be identified with the Section 409(a) of the Federal Food,
Activities; Submission for Office of
OMB control number 0910–0016 and Drug, and Cosmetic Act (the FD&C Act)
Management and Budget Review;
title ‘‘Submission of Petitions: Food (21 U.S.C. 348(a)) provides that a food
Comment Request; Submission of
Additive, Color Additive (Including additive shall be deemed to be unsafe,
Petitions: Food Additive, Color
Labeling), Submission of Information to unless: (1) The additive and its use, or
Additive (Including Labeling),
a Master File in Support of Petitions; intended use, are in conformity with a
Submission of Information to a Master
and Electronic Submission Using Food regulation issued under section 409 of
File in Support of Petitions; and
and Drug Administration Form 3503.’’ the FD&C Act that describes the
Electronic Submission Using Food and
Also include the FDA docket number condition(s) under which the additive
Drug Administration Form 3503
found in brackets in the heading of this may be safely used; (2) the additive and
AGENCY: Food and Drug Administration, document. its use, or intended use, conform to the
terms of an exemption for
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: Ila investigational use; or (3) a food contact
Mizrachi, Office of Operations, Food notification submitted under section
SUMMARY: The Food and Drug and Drug Administration, Three White 409(h) is effective. Food additive
Administration (FDA) is announcing Flint North, 10A–12M, 11601 petitions (FAPs) are submitted by
that a proposed collection of Landsdown St., North Bethesda, MD individuals or companies to obtain
information has been submitted to the 20852, 301–796–7726, PRAStaff@ approval of a new food additive or to
Office of Management and Budget fda.hhs.gov. amend the conditions of use permitted
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Document Created: 2018-10-24 11:54:25
Document Modified: 2018-10-24 11:54:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by September 21, 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 39792 |
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