81 FR 76596 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 213 (November 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 213 (November 3, 2016)
| Page Range | 76596-76598 | |
| FR Document | 2016-26528 |
[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)] [Notices] [Pages 76596-76598] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26528] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0403] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards 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 December 5, 2016. 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 0910-0755. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [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. Protection of Human Subjects: Informed Consent; Institutional Review Boards OMB Control Number 0910-0755--Extension Part 50 (21 CFR part 50) applies to all clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i) and 360j(g), respectively), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods and dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with part 50 is intended to protect the rights and safety of subjects involved in investigations filed with FDA under sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 379e, and 381, respectively) and sections 351 and 354-360F of the Public Health Service Act. With few exceptions, no investigator may involve a human being as a subject in FDA-regulated research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative (see Sec. 50.20). In seeking informed consent, each subject must be provided with certain elements of informed consent. Those elements are listed in Sec. 50.25. Informed consent shall be documented in writing as described in Sec. 50.27. An institutional review board (IRB) may approve emergency research without requiring the informed consent of all research subjects provided the IRB finds and documents that certain criteria are met as required in Sec. 50.24. We estimate that about eight times per year an IRB is requested to review emergency research under Sec. 50.24. We estimate, of the 8 yearly requests for IRB review under Sec. 50.24, a particular IRB will take about an hour during each of three separate fully convened IRB meetings to review the request under Sec. 50.24 (one meeting occurring after community consultation). The total annual reporting burden for IRB review of emergency research under Sec. 50.24 is estimated at 24 hours (see table 1). The information requested in the regulations for exception from the general requirements for informed consent for medical devices (21 CFR 812.47), and the information requested in the regulations for exception from the general requirements of informed consent in Sec. 50.23, paragraphs (a) through (c) and (e), is currently approved under OMB control number 0910-0586. The information requested in the investigational new drug (IND) regulations concerning exception from informed consent for emergency research under Sec. 50.24 is currently approved under OMB control number 0910-0014. In addition, the information requested in the regulations for IND safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans (21 CFR 320.31(d) [[Page 76597]] and 21 CFR 312.32(c)(1)(ii) and (iv)) is currently approved under OMB control number 0910-0672. Some clinical investigations involving children, although otherwise not approvable, may present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (see Sec. 50.54). Certain clinical investigations involving children may proceed if the IRB finds and documents that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and when the Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines and following opportunity for public review and comment, makes a determination that certain conditions are met (see Sec. 50.54(b)). The information requested for clinical investigations in children of FDA-regulated products is covered by the collections of information in the IND regulations (part 312 (21 CFR part 312)), the investigational device exemption (IDE) regulations (part 812 (21 CFR part 812)), the IRB regulations (Sec. 56.115 (21 CFR 56.115)), the food additive petition and nutrient content claim petition regulations (21 CFR 101.69 and 101.70), and the infant formula regulations (parts 106 and 107 (21 CFR parts 106 and 107)), all of which are approved by OMB. Specifically, the information collected under the IND regulations is currently approved under OMB control number 0910-0014. The information collected under the IDE regulations is currently approved under OMB control number 0910-0078. The information collected under the IRB regulations is currently approved under OMB control number 0910- 0130. The information collected in food additive and nutrient content claim petitions is currently approved under OMB control number 0910- 0381 (general requirements) and 0910-0016 (Form FDA 3503). The information collected under the infant formula regulations is currently approved under OMB control number 0910-0256 (general requirements) and 0910-0188 (infant formula recalls). Part 56 (21 CFR part 56) contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by FDA under sections 505(i) and 520(g) of the FD&C Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods and dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with part 56 is intended to protect the rights and welfare of human subjects involved in such investigations. The information collected under the IRB regulations ``Protection of Human Subjects--Recordkeeping and Reporting Requirements for Institutional Review Boards (part 56),'' including the information collection activities in the provisions in Sec. 56.108(a)(1) and (b), is currently approved under OMB control number 0910-0130. The information collected under the regulations for the registration of IRBs in Sec. 56.106 is currently approved under OMB control number 0990-0279. The information collected for IRB review and approval for the IDE regulations (part 812) is currently approved under OMB control number 0910-0078. The information collected for premarket approval of medical devices (part 814 (21 CFR part 814)) is currently approved under OMB control number 0910-0231. The information collected under the regulations for IRB requirements for humanitarian use devices (part 814, subpart H) is currently approved under OMB control number 0910- 0332. The information collected under the regulations for IRB review and approval of INDs (part 312) is currently approved under OMB control number 0910-0014. This collection of information is limited to certain provisions in part 50, subpart B (Informed Consent of Human Subjects), and part 56 (Institutional Review Boards), currently approved under OMB control number 0910-0755. This proposed extension applies to the following collections of information in part 50: Sec. Sec. 50.24 (Exception from informed consent requirements for emergency research), 50.25 (Elements of informed consent), and 50.27 (Documentation of informed consent). In part 56, this proposed extension applies to the following collections of information: Sec. 56.109(d) (written statement about research when documentation of informed consent is waived); Sec. 56.109(e) (IRB written notification to approve or disapprove research); Sec. 56.109(f) (continuing review of research); Sec. 56.109(g) (IRB written statements to the sponsor about required public disclosures related to emergency research under Sec. 50.24); Sec. 56.113 (Suspension or termination of IRB approval of research); Sec. 56.120(a) (IRB response to lesser administrative actions for noncompliance); and, Sec. 56.123 (Reinstatement of an IRB or an institution). In Sec. 56.109(d), if an IRB has waived documentation of consent for research that: (1) Presents no more than minimal risk of harm to subjects and (2) involves no procedures for which consent is normally required outside of the research context, the IRB may nevertheless require the investigator to provide a written statement about the research to the subjects. We estimate that each IRB will review about two minimal risk FDA-regulated studies each year. Because the studies are minimal risk, the review can be fairly straightforward, and the written statement for the subjects would be brief. We estimate that IRB review of each written statement could be completed in less than 30 minutes (0.5 hours). In Sec. 56.109(f), the amount of time an IRB spends on the continuing review of a particular study will vary depending on the nature and complexity of the research, the amount and type of new information presented to the IRB, and whether the investigator is seeking approval of substantive changes to the research protocol or informed consent document. For many studies, continuing review can be fairly straightforward, and the IRB should be able to complete its deliberations and approve the research within a brief period of time. In Sec. 56.109(g), an IRB is required to provide the sponsor of a study involving an exception from informed consent for emergency research under Sec. 50.24 with a written statement of information that has been publicly disclosed to the communities in which the investigation will be conducted and from which the subjects will be drawn. Public disclosure prior to initiation of the investigation would include the plans for the investigation and its risks and expected benefits. There must also be public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results. (See Sec. 50.24(a)(7)(ii) and (iii)). The purpose of the IRB's written statements is to make the sponsor aware that public disclosure has occurred, so that the sponsor can provide copies of the information that has been disclosed to FDA, as required by Sec. Sec. 312.54(a) and 812.47(a). We estimate that about eight requests to review emergency research under Sec. 50.24 are submitted each year, and the IRBs that review those studies would prepare two public disclosure reports: One prior to initiation of the research and one following the study's [[Page 76598]] completion. We estimate that it will take an IRB approximately 1 hour to prepare a written statement to the study sponsor describing each public disclosure, for a total of 2 hours per study. The total annual third party disclosure burden for IRBs to fulfill this requirement related to emergency research under Sec. 50.24 is estimated at 16 hours (see table 2). When an IRB or institution violates the regulations, FDA issues to the IRB or institution a noncompliance letter (see Sec. 56.120(a)). The IRB or institution must respond to the noncompliance letter describing the corrective actions that will be taken by the IRB or institution. FDA estimates about seven IRBs or institutions will be issued a noncompliance letter annually. We estimate that the IRB's or institution's response will take about 10 hours to prepare, with an estimated total annual burden of 70 hours. In 2016, FDA disqualified one IRB under Sec. 56.121. To date, no IRB or institution has been reinstated or applied for reinstatement under Sec. 56.123. For this reason, we estimate the annual reporting burden for one respondent only. We estimate a 5-hour burden per response, with an estimated total annual burden of 5 hours. The regulatory provisions in parts 50 and 56 currently approved under this collection of information, OMB control number 0910-0755, and for which this extension is requested, are shown in table 1. In the Federal Register of July 19, 2016 (81 FR 46935), 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\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 56.109(d) Written statement 2,520 2 5,040 .5 (30 minutes). 2,520 about minimal risk research when documentation of informed consent is waived. 56.109(e) IRB written 2,520 40 100,800 1............... 100,800 notification to approve or disapprove research; 56.109(f) Continuing review; 50.25 Elements of informed consent; and 50.27 Documentation of informed consent. 50.24 Exception from informed 8 3 24 1............... 24 consent requirements for emergency research. 56.113 Suspension or 2,520 1 2,520 .5 (30 minutes). 1,260 termination of IRB approval of research. 56.120(a) IRB response to 7 1 7 10.............. 70 lesser administrative actions for noncompliance. 56.123 Reinstatement of an IRB 1 1 1 5............... 5 or an institution. --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 104,679 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- 56.109(g) IRB written statement about public disclosures to sponsor 8 2 16 1 16 of emergency research under 50.24................................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26528 Filed 11-2-16; 8:45 am] BILLING CODE 4164-01-P
![76596 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices
are being conducted. Administrative DEPARTMENT OF HEALTH AND additives, drugs for human use, medical
data from multiple sources are also HUMAN SERVICES devices for human use, biological
being collected and evaluated. A grants products for human use, and electronic
management information system was Food and Drug Administration products. Compliance with part 50 is
developed for grantees to use to conduct [Docket No. FDA–2013–N–0403] intended to protect the rights and safety
random assignment, enroll individuals of subjects involved in investigations
into the project, and document service Agency Information Collection filed with FDA under sections 403, 406,
delivery. Activities; Submission for Office of 409, 412, 413, 502, 503, 505, 510, 513–
Management and Budget Review; 516, 518–520, 721, and 801 of the FD&C
DATES: The period of support for this Comment Request; Protection of Act (21 U.S.C. 343, 346, 348, 350a, 350b,
supplement is September 30, 2016 Human Subjects: Informed Consent; 352, 353, 355, 360, 360c–360f, 360h–
through September 29, 2017. Institutional Review Boards 360j, 379e, and 381, respectively) and
sections 351 and 354–360F of the Public
FOR FURTHER INFORMATION CONTACT: AGENCY: Food and Drug Administration, Health Service Act.
Elaine Sorensen, Office of Child HHS. With few exceptions, no investigator
Support Enforcement, 330 C Street SW., ACTION: Notice. may involve a human being as a subject
5th Floor, Washington, DC 20201. in FDA-regulated research unless the
Telephone: 202–401–5099; Email: SUMMARY: The Food and Drug investigator has obtained the legally
Elaine.sorensen@acf.hhs.gov. Administration (FDA) is announcing effective informed consent of the subject
that a proposed collection of or the subject’s legally authorized
SUPPLEMENTARY INFORMATION: Given the information has been submitted to the
importance of child support outcomes representative (see § 50.20). In seeking
Office of Management and Budget informed consent, each subject must be
for the evaluation of CSPED, OCSE has (OMB) for review and clearance under provided with certain elements of
asked the Wisconsin Department of the Paperwork Reduction Act of 1995. informed consent. Those elements are
Children and Families to expand the DATES: Fax written comments on the listed in § 50.25. Informed consent shall
child support outcomes included in the collection of information by December be documented in writing as described
evaluation, requiring additional 5, 2016. in § 50.27.
collection of child support ADDRESSES: To ensure that comments on An institutional review board (IRB)
administrative data and additional the information collection are received, may approve emergency research
analyses of these data. In addition, the OMB recommends that written without requiring the informed consent
Wisconsin Department of Children and comments be faxed to the Office of of all research subjects provided the IRB
Families provided OCSE with Information and Regulatory Affairs, finds and documents that certain
preliminary impact findings using child OMB, Attn: FDA Desk Officer, FAX: criteria are met as required in § 50.24.
support administrative data, which 202–395–7285, or emailed to oira_ We estimate that about eight times per
uncovered further unexpected submission@omb.eop.gov. All year an IRB is requested to review
complications with the child support comments should be identified with the emergency research under § 50.24. We
administrative data. OCSE has asked the OMB control number 0910–0755. Also estimate, of the 8 yearly requests for IRB
Wisconsin Department of Children and include the FDA docket number found review under § 50.24, a particular IRB
Families to go back and collect in brackets in the heading of this will take about an hour during each of
additional child support administrative document. three separate fully convened IRB
meetings to review the request under
data to further understand these FOR FURTHER INFORMATION CONTACT: FDA § 50.24 (one meeting occurring after
complications and report their findings PRA Staff, Office of Operations, Food community consultation). The total
to OCSE. Finally, given the strong focus and Drug Administration, Three White annual reporting burden for IRB review
on child support outcomes for this Flint North 10A–12M, 11601 of emergency research under § 50.24 is
evaluation, OCSE has asked the Landsdown St., North Bethesda, MD estimated at 24 hours (see table 1).
evaluator to add a second impact report 20852, PRAStaff@fda.hhs.gov. The information requested in the
that focuses exclusively on child SUPPLEMENTARY INFORMATION: In regulations for exception from the
support outcomes. compliance with 44 U.S.C. 3507, FDA general requirements for informed
Statutory Authority: Section 1115 of the has submitted the following proposed consent for medical devices (21 CFR
Social Security Act authorizes funds for collection of information to OMB for 812.47), and the information requested
experimental, pilot, or demonstration review and clearance. in the regulations for exception from the
projects that are likely to assist in promoting general requirements of informed
Protection of Human Subjects: Informed consent in § 50.23, paragraphs (a)
the objectives of Part D of Title IV. Consent; Institutional Review Boards through (c) and (e), is currently
Christopher Beach, OMB Control Number 0910–0755— approved under OMB control number
Certifying Official, Senior Grants Policy
Extension 0910–0586. The information requested
Specialist, Division of Grants Policy, Office Part 50 (21 CFR part 50) applies to all in the investigational new drug (IND)
of Administration. clinical investigations regulated by FDA regulations concerning exception from
[FR Doc. 2016–26560 Filed 11–2–16; 8:45 am] under sections 505(i) and 520(g) of the informed consent for emergency
BILLING CODE 4184–42–P Federal Food, Drug, and Cosmetic Act research under § 50.24 is currently
(the FD&C Act) (21 U.S.C. 355(i) and approved under OMB control number
mstockstill on DSK3G9T082PROD with NOTICES
360j(g), respectively), as well as clinical 0910–0014. In addition, the information
investigations that support applications requested in the regulations for IND
for research or marketing permits for safety reporting requirements for human
products regulated by FDA, including drug and biological products and safety
foods and dietary supplements that bear reporting requirements for
a nutrient content claim or a health bioavailability and bioequivalence
claim, infant formulas, food and color studies in humans (21 CFR 320.31(d)
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![76598 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices
completion. We estimate that it will take institution. FDA estimates about seven The regulatory provisions in parts 50
an IRB approximately 1 hour to prepare IRBs or institutions will be issued a and 56 currently approved under this
a written statement to the study sponsor noncompliance letter annually. We collection of information, OMB control
describing each public disclosure, for a estimate that the IRB’s or institution’s number 0910–0755, and for which this
total of 2 hours per study. The total response will take about 10 hours to extension is requested, are shown in
annual third party disclosure burden for prepare, with an estimated total annual table 1.
IRBs to fulfill this requirement related to burden of 70 hours.
emergency research under § 50.24 is In 2016, FDA disqualified one IRB In the Federal Register of July 19,
estimated at 16 hours (see table 2). under § 56.121. To date, no IRB or 2016 (81 FR 46935), FDA published a
When an IRB or institution violates institution has been reinstated or 60-day notice requesting public
the regulations, FDA issues to the IRB applied for reinstatement under comment on the proposed collection of
or institution a noncompliance letter § 56.123. For this reason, we estimate information. No comments were
(see § 56.120(a)). The IRB or institution the annual reporting burden for one received.
must respond to the noncompliance respondent only. We estimate a 5-hour FDA estimates the burden of this
letter describing the corrective actions burden per response, with an estimated collection of information as follows:
that will be taken by the IRB or total annual burden of 5 hours.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
21 CFR section responses per Total hours
respondents responses per response
respondent
56.109(d) Written statement about minimal risk re- 2,520 2 5,040 .5 (30 minutes) ..... 2,520
search when documentation of informed consent is
waived.
56.109(e) IRB written notification to approve or dis- 2,520 40 100,800 1 ............................ 100,800
approve research; 56.109(f) Continuing review;
50.25 Elements of informed consent; and 50.27
Documentation of informed consent.
50.24 Exception from informed consent requirements 8 3 24 1 ............................ 24
for emergency research.
56.113 Suspension or termination of IRB approval of 2,520 1 2,520 .5 (30 minutes) ..... 1,260
research.
56.120(a) IRB response to lesser administrative ac- 7 1 7 10 .......................... 70
tions for noncompliance.
56.123 Reinstatement of an IRB or an institution ........ 1 1 1 5 ............................ 5
Total ....................................................................... ........................ ........................ ........................ ............................... 104,679
1 There are no capital costs or operating and maintenance 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 section burden per Total hours
respondents per disclosures disclosure
respondent
56.109(g) IRB written statement about public disclosures
to sponsor of emergency research under 50.24 .............. 8 2 16 1 16
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 28, 2016. DEPARTMENT OF HEALTH AND Authorizations) for in vitro diagnostic
Leslie Kux, HUMAN SERVICES devices for detection of the Zika virus
Associate Commissioner for Policy. in response to the Zika virus outbreak
Food and Drug Administration in the Americas. FDA issued these
[FR Doc. 2016–26528 Filed 11–2–16; 8:45 am]
Authorizations under the Federal Food,
BILLING CODE 4164–01–P
[Docket No. FDA–2016–N–1486] Drug, and Cosmetic Act (the FD&C Act),
as requested by Vela Diagnostics USA,
Authorizations of Emergency Use of In Inc. and ARUP Laboratories. The
Vitro Diagnostic Devices for Detection Authorizations contain, among other
of Zika Virus; Availability things, conditions on the emergency use
Food and Drug Administration, of the authorized in vitro diagnostic
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY:
HHS. devices. The Authorizations follow the
ACTION: Notice. February 26, 2016, determination by the
Secretary of Health and Human Services
SUMMARY: The Food and Drug (HHS) that there is a significant
Administration (FDA) is announcing the potential for a public health emergency
issuance of two Emergency Use that has a significant potential to affect
Authorizations (EUAs) (the national security or the health and
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Document Created: 2016-11-03 03:24:15
Document Modified: 2016-11-03 03:24:15
| 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 December 5, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 76596 |
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