82 FR 18294 - Agency Information Collection Activities; Proposed Collection; 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 73 (April 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 73 (April 18, 2017)
| Page Range | 18294-18296 | |
| FR Document | 2017-07768 |
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)] [Notices] [Pages 18294-18296] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07768] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0062] Agency Information Collection Activities; Proposed Collection; 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 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 (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 regarding exception from the general requirements for informed consent. DATES: Submit either electronic or written comments on the collection of information by June 19, 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 [[Page 18295]] 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-2010-N-0062 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent.'' 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: https://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: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. 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. Medical Devices; Exception From General Requirements for Informed Consent--21 CFR 50.23 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 [[Page 18296]] 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 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. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Total operating 21 CFR Section Number of responses per Total annual Average burden Total hours and maintenance respondents respondent responses per response costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Written certification (sent to FDA)--50.23(e)(3).. 150 3 450 0.25 113 $200 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR Part Number of disclosures Total annual burden per Total hours respondents per respondent disclosures disclosure ---------------------------------------------------------------------------------------------------------------- Written certification (sent to 150 3 450 2 900 IRB)--50.23(e)(1) and (e)(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: April 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-07768 Filed 4-17-17; 8:45 am] BILLING CODE 4164-01-P
![18294 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
purposes of surveillance, mitigation, member logs in to the system). For the to the Reportable Food Registry, who
work planning, and supporting the LivestockNet report, additional data performed the analysis); and results
animal food standard requirements. elements specific to livestock animals information (analyte, test method,
PETNet and LivestockNet reports will be captured: Product details analytical results, whether the results
share the following common data (indication of whether the product is a contradict a label claim or guarantee,
elements, the majority of which are drop medicated feed under 21 CFR and whether action was taken as a result
down menu choices: Product details 558.3(b)(8), product packaging, and of the sample analysis).
(product name, lot code, product form, intended purpose of the product), class Description of Respondents:
and the manufacturer or distributor/ of the animal species affected, and Respondents to the collection of
packer (if known)), the species affected, production loss. For PETNet reports, the information are Federal, State, and
number of animals exposed to the only additional data field is the animal Territorial regulatory and public health
product, number of animals affected, life stage. The proposed SampleNet Agency employees with membership
body systems affected, product reports will have the following data access to the Animal Feed Network.
problem/defect, date of onset or the date elements, many of which are drop down In the Federal Register of March 15,
product problem was detected, the State menu choices: Product information 2016 (81 FR 13794), FDA published a
where the incident occurred, the origin (product name, lot code, guarantor 60-day notice requesting public
of the information, whether there are information, date and location of sample comment on the proposed collection of
supporting laboratory results, and collection, and product description); information. No comments were
contact information for the reporting laboratory information (sample received.
member (i.e., name, telephone number identification number, the reason for FDA estimates the burden of this
will be captured automatically when testing, whether the food was reported 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
PETNet ................................................................................. 20 5 100 * 0.25 25
LivestockNet ......................................................................... 20 5 100 * 0.25 25
SampleNet ........................................................................... 20 5 100 * 0.25 25
Total .............................................................................. 75 ........................ ........................ ........................ ........................
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 15 minutes.
Our estimate is based on our announcing an opportunity for public comment will be made public, you are
experience with the tracking network comment on the proposed collection of solely responsible for ensuring that your
over the past 3 years. We estimate that certain information by the Agency. comment does not include any
we will receive an average of 5 Under the Paperwork Reduction Act of confidential information that you or a
submissions from 20 respondents for 1995 (PRA), Federal Agencies are third party may not wish to be posted,
each type of report, and that it will take required to publish notice in the such as medical information, your or
15 minutes (0.25 hour) per response. Federal Register concerning each anyone else’s Social Security number, or
Dated: April 11, 2017. proposed collection of information, confidential business information, such
Anna K. Abram, including each proposed extension of an as a manufacturing process. Please note
Deputy Commissioner for Policy, Planning,
existing collection of information, and that if you include your name, contact
Legislation, and Analysis. to allow 60 days for public comment in information, or other information that
[FR Doc. 2017–07769 Filed 4–17–17; 8:45 am]
response to the notice. This notice identifies you in the body of your
solicits comments on the information comments, that information will be
BILLING CODE 4164–01–P
collection regarding exception from the posted on https://www.regulations.gov.
general requirements for informed • If you want to submit a comment
DEPARTMENT OF HEALTH AND consent. with confidential information that you
HUMAN SERVICES do not wish to be made available to the
DATES: Submit either electronic or
public, submit the comment as a
written comments on the collection of
Food and Drug Administration written/paper submission and in the
information by June 19, 2017.
manner detailed (see ‘‘Written/Paper
[Docket No. FDA–2010–N–0062] ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’).
as follows:
Agency Information Collection Written/Paper Submissions
Activities; Proposed Collection; Electronic Submissions
Submit written/paper submissions as
Comment Request; Medical Devices; Submit electronic comments in the follows:
Exception From General Requirements following way: • Mail/Hand delivery/Courier (for
sradovich on DSK3GMQ082PROD with NOTICES
for Informed Consent • Federal eRulemaking Portal: written/paper submissions): Division of
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the Dockets Management (HFA–305), Food
HHS. instructions for submitting comments. and Drug Administration, 5630 Fishers
ACTION: Notice. Comments submitted electronically, Lane, Rm. 1061, Rockville, MD 20852.
including attachments, to https:// • For written/paper comments
SUMMARY: The Food and Drug www.regulations.gov will be posted to submitted to the Division of Dockets
Administration (FDA or Agency) is the docket unchanged. Because your Management, FDA will post your
VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/82_FR_18367/page/1.svg)
![18296 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
test results are reported to the subject’s devices to identify chemical, biological, estimate the operating and maintenance
health care provider and public health radiological, or nuclear agents. FDA cost of $200 for copying and mailing the
authorities, as applicable. Under estimates that in the United States each information to FDA.
§ 50.23(e)(4), the investigator provides year there are approximately 450 Based on its knowledge of similar
the IRB with the information required naturally occurring cases of diseases or types of submissions, FDA estimates
by § 50.25 (21 CFR 50.25) (except for the conditions that are identified in the that it will take about 1 hour to prepare
information described in § 50.25(a)(8)) Centers for Disease Control and a report disclosing the investigational
and the procedures that will be used to Prevention’s list of category ‘‘A’’ status of the in vitro diagnostic device
provide this information to each subject biological threat agents. The number of and what is known about the
or the subject’s legally authorized cases that would result from a terrorist performance characteristics of the
representative. event or other public health emergency device and submit it to the health care
FDA estimates that there are is uncertain. Based on its knowledge of provider and, where appropriate, to
approximately 150 laboratories that similar types of submissions, FDA public health authorities.
could perform testing that uses estimates that it will take about 2 hours FDA estimates the burden of this
investigational in vitro diagnostic to prepare each certification. We collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total operating
Number of Average
Number of Total annual and
21 CFR Section responses per burden per Total hours
respondents responses maintenance
respondent response costs
Written certification (sent to FDA)—
50.23(e)(3) ............................................ 150 3 450 0.25 113 $200
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 (e)(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: April 11, 2017. provide advice and recommendations to Electronic Submissions
Anna K. Abram, the Agency on FDA’s regulatory issues. Submit electronic comments in the
Deputy Commissioner for Policy, Planning, The meeting will be open to the public. following way:
Legislation, and Analysis. FDA is establishing a docket for public • Federal eRulemaking Portal:
[FR Doc. 2017–07768 Filed 4–17–17; 8:45 am] comment on this document. https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P instructions for submitting comments.
DATES: The meeting will be held on May
Comments submitted electronically,
24, 2017, from 8 a.m. to 5 p.m. The
including attachments, to https://
DEPARTMENT OF HEALTH AND docket number is FDA–2017–N–1063. www.regulations.gov will be posted to
HUMAN SERVICES The docket will close on May 23, 2017. the docket unchanged. Because your
Comments received on or before May comment will be made public, you are
Food and Drug Administration 10, 2017, will be provided to the solely responsible for ensuring that your
committee. Comments received after comment does not include any
[Docket No. FDA–2017–N–2093] that date will be taken into confidential information that you or a
consideration by the Agency. third party may not wish to be posted,
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a ADDRESSES: FDA White Oak Campus, such as medical information, your or
Public Docket; Request for Comments 10903 New Hampshire Ave., Building anyone else’s Social Security number, or
31 Conference Center, the Great Room confidential business information, such
AGENCY: Food and Drug Administration, as a manufacturing process. Please note
(Rm. 1503), Silver Spring, MD 20993.
HHS. that if you include your name, contact
Answers to commonly asked questions
ACTION: Notice; establishment of a information, or other information that
including information regarding special
sradovich on DSK3GMQ082PROD with NOTICES
public docket; request for comments. identifies you in the body of your
accommodations due to a disability, comments, that information will be
SUMMARY: The Food and Drug visitor parking, and transportation may posted on https://www.regulations.gov.
Administration (FDA) announces a be accessed at: https://www.fda.gov/ • If you want to submit a comment
forthcoming public advisory committee AdvisoryCommittees/ with confidential information that you
meeting of the Oncologic Drugs AboutAdvisoryCommittees/ do not wish to be made available to the
Advisory Committee (ODAC). The ucm408555.htm. You may submit public, submit the comment as a
general function of the committee is to comments as follows: written/paper submission and in the
VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/82_FR_18367/page/3.svg)
Document Created: 2017-04-18 00:00:00
Document Modified: 2017-04-18 00:00:00
| 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 June 19, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 18294 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR