81 FR 34345 - Agency Information Collection Activities; Proposed Collection; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34345-34347 | |
| FR Document | 2016-12651 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34345-34347] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12651] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3327] Agency Information Collection Activities; Proposed Collection; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collections of information marked as ``ADDENDUM'' in the draft guidance entitled ``E6(R2) Good Clinical Practice'' (E6(R2) draft guidance). The E6(R2) draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E6(R2) draft guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance'' (E6(R1) consolidated guidance), issued in April 1996, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and data integrity. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated. The E6(R2) draft guidance was intended to improve clinical trial quality and efficiency while maintaining human subject protection. This notice solicits comments on the collection of information in the draft guidance concerning the development of a system to manage quality, as well as information to include in a clinical study report about the quality management approach. DATES: Submit either electronic or written comments on the collection of information by August 1, 2016 on the ``ADDENDUM'' sections of the E6(R2) draft guidance. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 Submission'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-D-3327 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food [[Page 34346]] and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information 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. E6(R2) Good Clinical Practice Draft Guidance; International Council for Harmonisation OMB Control Number 0910-NEW I. Background In the Federal Register of September 29, 2015 (80 FR 58492), we announced the availability of and requested public comments on the E6(R2) draft guidance. The draft guidance is the product of the ICH E6 Expert Working Group of the ICH. The E6(R2) draft guidance provides additions to the E6(R1) consolidated guidance that are identified as ``ADDENDUM'' and marked with vertical lines on both sides of the text. The additions are intended to encourage implementation of the described approaches and processes to improve the quality and efficiency of clinical trials while maintaining the protection of human subjects. The E6(R2)draft guidance includes information collection provisions that are subject to review by OMB under the PRA. This Federal Register notice begins the process of requesting public comment and obtaining OMB approval for those information collections that are new and are not already covered by previously approved collections of information. II. Burden Estimates for the E6(R2) Draft Guidance The E6(R2) draft guidance recommends that sponsors develop and maintain a system to manage quality when designing, conducting, recording, evaluating, reporting, and archiving clinical trials. The draft guidance also recommends that the sponsor describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits in the clinical study report. We are requesting OMB approval for the following collections of information identified in the ``ADDENDUM'' sections of the E6(R2) draft guidance and are inviting public comments on these sections. In table 1 of this document, we estimate that approximately 1,457 sponsors of clinical trials of human drugs will develop approximately 1,457 quality management systems per year (as described in section 5.0 of the E6(R2) draft guidance). We further estimate that it will take sponsors approximately 60 hours to develop and implement each quality management system, totaling 87,420 hours annually. These estimates are based on the number of annual investigational new drug applications (IND) and new drug applications (NDA) submitted to the Center for Drug Evaluation and Research in previously approved collections of information. The estimated number of sponsors that will develop a quality management system as described in the guidance, as well as the estimated number of hours it will take, is based on FDA interactions with sponsors about activities that support drug development plans. In table 2 of this document, we estimate that approximately 1,457 sponsors of clinical trials of human drugs will describe the quality management approach implemented in a clinical trial and summarize important deviations from the predefined quality tolerance limits in a clinical study report (as described in section 5.0.7 of the E6(R2) draft guidance). We further estimate that sponsors will submit approximately 4.6 responses per respondent and that it will take sponsors 3 hours to complete this reporting task, totaling 20,107 reporting hours annually. These estimates are based on past experiences with IND, NDA, and previously approved collections of information. In table 3 of this document, we estimate that approximately 218 sponsors of clinical trials of biological products will develop approximately 218 quality management systems per year (as described in section 5.0.7 of the E6(R2) draft guidance). We further estimate that it will take sponsors approximately 60 hours to develop and implement each quality management system, totaling 13,080 hours annually. These estimates are based on past experiences with INDs, biologics license applications (BLA), and previously approved collections of information. In table 4 of this document, we estimate that 218 sponsors of biological products will describe the quality management approach implemented in a clinical trial and summarize important deviations from the predefined quality tolerance limits in a clinical study report (as described in section 5.0.7 of the E6(R2) draft guidance). We further estimate that sponsors will submit approximately 3.69 responses per respondent and that it will take sponsors 3 hours to complete this reporting task, totaling 2,413 reporting hours annually. As described previously, these estimates are also based on past experiences with IND, BLA, and previously approved collections of information. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden for Human Drugs \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden E6(R2) Good Clinical Practice; International Council for Number of records per Total annual per Total hours Harmonisation; Draft Guidance for Industry recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Section 5.0--Quality Management (including sections 5.0.1 to 5.0.7) 1,457 1 1,457 60 87,420 [[Page 34347]] Developing a Quality Management System............................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Reporting Burden for Human Drugs \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of E6(R2) Good Clinical Practice; International Council for Number of responses per Total annual Average burden Total hours Harmonisation; Draft Guidance for Industry respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Section 5.0.7--Risk Reporting...................................... 1,457 4.6 6,702 3 20,107 Describing the Quality Management Approach Implemented in a Clinical Trial and Summarizing Important Deviations From the Predefined Quality Tolerance Limits in a Clinical Study Report.... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3--Estimated Annual Recordkeeping Burden for Biologics \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of E6(R2) Good Clinical Practice; International Council for Number of records per Total records Average burden Total hours Harmonisation; Draft Guidance for Industry recordkeepers recordkeeper per record -------------------------------------------------------------------------------------------------------------------------------------------------------- Section 5.0--Quality Management (including 5.0.1 to 5.0.7)......... 218 1 218 60 13,080 Developing a Quality Management System............................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 4--Estimated Annual Reporting Burden for Biologics \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of E6(R2) Good Clinical Practice; International Council for Number of responses per Total annual Average burden Total hours Harmonisation; Draft Guidance for Industry responses respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Section 5.0.7--Risk Reporting...................................... 218 3.69 804 3 2,413 Describing the Quality Management Approach Implemented in a Clinical Trial and Summarizing Important Deviations From the Predefined Quality Tolerance Limits in a Clinical Study Report.... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The collections of information included in the sections marked as ``ADDENDUM'' in the E6(R2) draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information found in 21 CFR part 11 have been approved under OMB control number 0910-0303; the collections of information found in 21 CFR part 312 have been approved under OMB control number 0910-0014; and collections of information found in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information found in 21 CFR part 601 have been approved under OMB control number 0910-0338. Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12651 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34345
contacting the Designated Federal data integrity. Standards regarding except for information submitted,
Officer (see FOR FURTHER INFORMATION electronic records and essential marked and identified, as confidential,
CONTACT). In light of the fact that no documents intended to increase clinical if submitted as detailed in
change has been made to the committee trial quality and efficiency have also ‘‘Instructions.’’
name or description of duties, no been updated. The E6(R2) draft Instructions: All submissions received
amendment will be made to 21 CFR guidance was intended to improve must include the Docket No. FDA–
14.100. clinical trial quality and efficiency 2015–D–3327 for ‘‘Agency Information
This document is issued under the while maintaining human subject Collection Activities; Proposed
Federal Advisory Committee Act (5 protection. This notice solicits Collection; Comment Request; E6(R2)
U.S.C. app.). For general information comments on the collection of Good Clinical Practice; International
related to FDA advisory committees, information in the draft guidance Council for Harmonisation.’’ Received
please visit us at http://www.fda.gov/ concerning the development of a system comments will be placed in the docket
AdvisoryCommittees/default.htm. to manage quality, as well as and, except for those submitted as
Dated: May 24, 2016. information to include in a clinical ‘‘Confidential Submissions,’’ publicly
Jill Hartzler Warner, study report about the quality viewable at http://www.regulations.gov
Associate Commissioner for Special Medical management approach. or at the Division of Dockets
Programs. DATES: Submit either electronic or Management between 9 a.m. and 4 p.m.,
[FR Doc. 2016–12637 Filed 5–27–16; 8:45 am] written comments on the collection of Monday through Friday.
BILLING CODE 4164–01–P information by August 1, 2016 on the • Confidential Submissions—To
‘‘ADDENDUM’’ sections of the E6(R2) submit a comment with confidential
draft guidance. information that you do not wish to be
DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
made publicly available, submit your
HUMAN SERVICES as follows: comments only as a written/paper
submission. You should submit two
Food and Drug Administration Electronic Submissions copies total. One copy will include the
[Docket No. FDA–2015–D–3327] Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
Agency Information Collection • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
Activities; Proposed Collection; www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Comment Request; E6(R2) Good instructions for submitting comments. Agency will review this copy, including
Clinical Practice; International Council Comments submitted electronically, the claimed confidential information, in
for Harmonisation including attachments, to http:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
AGENCY: Food and Drug Administration, claimed confidential information
HHS. the docket unchanged. Because your
comment will be made public, you are redacted/blacked out, will be available
ACTION: Notice. for public viewing and posted on http://
solely responsible for ensuring that your
SUMMARY: The Food and Drug comment does not include any www.regulations.gov. Submit both
Administration (FDA, we, or the confidential information that you or a copies to the Division of Dockets
Agency) is announcing an opportunity third party may not wish to be posted, Management. If you do not wish your
for public comment on the proposed such as medical information, your or name and contact information to be
collection of certain information by the anyone else’s Social Security number, or made publicly available, you can
Agency. Under the Paperwork confidential business information, such provide this information on the cover
Reduction Act of 1995 (the PRA), as a manufacturing process. Please note sheet and not in the body of your
Federal Agencies are required to publish that if you include your name, contact comments and you must identify this
notice in the Federal Register information, or other information that information as ‘‘confidential.’’ Any
concerning each proposed collection of identifies you in the body of your information marked as ‘‘confidential’’
information and to allow 60 days for comments, that information will be will not be disclosed except in
public comment in response to the posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
notice. This notice solicits comments on • If you want to submit a comment applicable disclosure law. For more
the collections of information marked as with confidential information that you information about FDA’s posting of
‘‘ADDENDUM’’ in the draft guidance do not wish to be made available to the comments to public dockets, see 80 FR
entitled ‘‘E6(R2) Good Clinical Practice’’ public, submit the comment as a 56469, September 18, 2015, or access
(E6(R2) draft guidance). The E6(R2) written/paper submission and in the the information at: http://www.fda.gov/
draft guidance was prepared under the manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
auspices of the International Council for Submission’’ and ‘‘Instructions’’). default.htm.
Harmonisation of Technical Docket: For access to the docket to
Requirements for Registration of Written/Paper Submissions read background documents or the
Pharmaceuticals for Human Use (ICH). Submit written/paper submissions as electronic and written/paper comments
The E6(R2) draft guidance amends the follows: received, go to http://
guidance entitled ‘‘E6 Good Clinical • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Practice: Consolidated Guidance’’ written/paper submissions): Division of docket number, found in brackets in the
sradovich on DSK3TPTVN1PROD with NOTICES
(E6(R1) consolidated guidance), issued Dockets Management (HFA–305), Food heading of this document, into the
in April 1996, to encourage and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
implementation of improved and more Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
efficient approaches to clinical trial • For written/paper comments Management, 5630 Fishers Lane, Rm.
design, conduct, oversight, recording, submitted to the Division of Dockets 1061, Rockville, MD 20852.
and reporting while continuing to Management, FDA will post your FOR FURTHER INFORMATION CONTACT: FDA
ensure human subject protection and comment, as well as any attachments, PRA Staff, Office of Operations, Food
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![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34347
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1—Continued
Number of Average bur-
E6(R2) Good Clinical Practice; International Council for Number of Total annual
records per den per rec- Total hours
Harmonisation; Draft Guidance for Industry recordkeepers records
recordkeeper ordkeeping
Developing a Quality Management System.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of re- Average bur-
E6(R2) Good Clinical Practice; International Council for Number of re- Total annual
sponses per den per re- Total hours
Harmonisation; Draft Guidance for Industry spondents responses
respondent sponse
Section 5.0.7—Risk Reporting ............................................. 1,457 4.6 6,702 3 20,107
Describing the Quality Management Approach Imple-
mented in a Clinical Trial and Summarizing Important
Deviations From the Predefined Quality Tolerance Lim-
its in a Clinical Study Report.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of
E6(R2) Good Clinical Practice; International Council for Number of Average bur-
records per Total records Total hours
Harmonisation; Draft Guidance for Industry recordkeepers den per record
recordkeeper
Section 5.0—Quality Management (including 5.0.1 to
5.0.7) ................................................................................ 218 1 218 60 13,080
Developing a Quality Management System.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
Number of re- Average bur-
E6(R2) Good Clinical Practice; International Council for Number of re- Total annual
sponses per den per re- Total hours
Harmonisation; Draft Guidance for Industry sponses responses
respondent sponse
Section 5.0.7—Risk Reporting ............................................. 218 3.69 804 3 2,413
Describing the Quality Management Approach Imple-
mented in a Clinical Trial and Summarizing Important
Deviations From the Predefined Quality Tolerance Lim-
its in a Clinical Study Report.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The collections of information Dated: May 24, 2016. DEPARTMENT OF HEALTH AND
included in the sections marked as Leslie Kux, HUMAN SERVICES
‘‘ADDENDUM’’ in the E6(R2) draft Associate Commissioner for Policy.
guidance also refers to previously Food and Drug Administration
[FR Doc. 2016–12651 Filed 5–27–16; 8:45 am]
approved collections of information BILLING CODE 4164–01–P [Docket No. FDA–2015–P–0403]
found in FDA regulations. These
collections of information are subject to Determination That LEVOTHROID
review by OMB under the PRA. The (Levothyroxine Sodium) Tablets, 0.025
collections of information found in 21 Milligram, 0.05 Milligram, 0.075
CFR part 11 have been approved under Milligram, 0.088 Milligram, 0.112
OMB control number 0910–0303; the Milligram, 0.125 Milligram, 0.137
collections of information found in 21 Milligram, 0.15 Milligram, 0.175
CFR part 312 have been approved under Milligram, 0.1 Milligram, 0.2 Milligram,
OMB control number 0910–0014; and and 0.3 Milligram, Were Not Withdrawn
collections of information found in 21 From Sale for Reasons of Safety or
Effectiveness
sradovich on DSK3TPTVN1PROD with NOTICES
CFR part 314 have been approved under
OMB control number 0910–0001. The AGENCY: Food and Drug Administration,
collections of information found in 21 HHS.
CFR part 601 have been approved under ACTION: Notice.
OMB control number 0910–0338.
SUMMARY: The Food and Drug
Administration (FDA or Agency) has
determined that LEVOTHROID
VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/81_FR_34449/page/3.svg)
Document Created: 2016-05-28 03:58:01
Document Modified: 2016-05-28 03:58:01
| 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 August 1, 2016 on the ``ADDENDUM'' sections of the E6(R2) draft guidance. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 34345 |
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