83 FR 32303 - Human Gene Therapy for Rare Diseases; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 134 (July 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 134 (July 12, 2018)
| Page Range | 32303-32305 | |
| FR Document | 2018-14871 |
[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)] [Notices] [Pages 32303-32305] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14871] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2258] Human Gene Therapy for Rare Diseases; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.'' The draft guidance document provides recommendations to stakeholders developing a human gene therapy (GT) product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself. DATES: Submit either electronic or written comments on the draft guidance by October 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the [[Page 32304]] 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-2258 for ``Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background The Orphan Drug Act of 1983 (Pub. L. 97-414) defines a rare disease as a disease or condition that affects fewer than 200,000 persons in the United States. Since most rare diseases have no approved therapies, there is a significant unmet need for effective treatments. However, developing safe and effective products to treat rare diseases can be challenging. For example, it may be more difficult to find and recruit such patients into clinical trials, and many rare diseases exhibit a number of variations or subtypes. Consequently, patients may have highly diverse clinical manifestations and rates of disease progression with unpredictable clinical courses. Despite these challenges, GT- related research and development continue to grow at a rapid rate, with several products advancing in clinical development. FDA is announcing the availability of a document entitled ``Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.'' The draft guidance provides recommendations to stakeholders developing a GT product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of two other human gene therapy draft guidance documents entitled ``Human Gene Therapy for Hemophilia; Draft Guidance for Industry'' and ``Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Human Gene Therapy for Rare Diseases.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0755; the [[Page 32305]] collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in the guidance entitled ``Expedited Programs for Serious Conditions--Drugs and Biologics'' have been approved under OMB control number 0910-0765; and the collections of information in the guidance entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' have been approved under OMB control number 0910-0429. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: July 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14871 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32303
for public viewing and posted on management, and include genetic as III. Electronic Access
https://www.regulations.gov. Submit well as age-related diseases. These Persons with access to the internet
both copies to the Dockets Management disorders manifest with central or may obtain the draft guidance at either
Staff. If you do not wish your name and peripheral visual impairment and often https://www.fda.gov/BiologicsBlood
contact information to be made publicly with progressive visual loss. The draft Vaccines/GuidanceCompliance
available, you can provide this guidance focuses on issues specific to RegulatoryInformation/Guidances/
information on the cover sheet and not GT products for retinal disorders and default.htm or https://
in the body of your comments and you provides recommendations related to www.regulations.gov.
must identify this information as product development, preclinical
‘‘confidential.’’ Any information marked Dated: July 5, 2018.
testing, and clinical trial design for such
as ‘‘confidential’’ will not be disclosed Leslie Kux,
GT products.
except in accordance with 21 CFR 10.20 Associate Commissioner for Policy.
and other applicable disclosure law. For Elsewhere in this issue of the Federal [FR Doc. 2018–14870 Filed 7–11–18; 8:45 am]
more information about FDA’s posting Register, FDA is announcing the BILLING CODE 4164–01–P
of comments to public dockets, see 80 availability of two other human gene
FR 56469, September 18, 2015, or access therapy draft guidance documents
the information at: https://www.gpo.gov/ entitled ‘‘Human Gene Therapy for DEPARTMENT OF HEALTH AND
fdsys/pkg/FR-2015-09-18/pdf/2015- Hemophilia; Draft Guidance for HUMAN SERVICES
23389.pdf. Industry’’ and ‘‘Human Gene Therapy
Docket: For access to the docket to for Rare Diseases; Draft Guidance for Food and Drug Administration
read background documents or the Industry.’’ [Docket No. FDA–2018–D–2258]
electronic and written/paper comments This draft guidance is being issued
received, go to https:// consistent with FDA’s good guidance Human Gene Therapy for Rare
www.regulations.gov and insert the practices regulation (21 CFR 10.115). Diseases; Draft Guidance for Industry;
docket number, found in brackets in the The draft guidance, when finalized, will Availability
heading of this document, into the represent the current thinking of FDA AGENCY: Food and Drug Administration,
‘‘Search’’ box and follow the prompts on ‘‘Human Gene Therapy for Retinal HHS.
and/or go to the Dockets Management Disorders.’’ It does not establish any
Staff, 5630 Fishers Lane, Rm. 1061, ACTION: Notice of availability.
rights for any person and is not binding
Rockville, MD 20852. on FDA or the public. You can use an SUMMARY: The Food and Drug
You may submit comments on any alternative approach if it satisfies the Administration (FDA or Agency) is
guidance at any time (see 21 CFR requirements of the applicable statutes announcing the availability of a draft
10.115(g)(5)). and regulations. This guidance is not document entitled ‘‘Human Gene
Submit written requests for single subject to Executive Order 12866. Therapy for Rare Diseases; Draft
copies of the draft guidance to the Office Guidance for Industry.’’ The draft
of Communication, Outreach and II. Paperwork Reduction Act of 1995 guidance document provides
Development, Center for Biologics recommendations to stakeholders
Evaluation and Research (CBER), Food This draft guidance refers to
previously approved collections of developing a human gene therapy (GT)
and Drug Administration, 10903 New product intended to treat a rare disease
Hampshire Ave., Bldg. 71, Rm. 3128, information subject to review by the
in adult and/or pediatric patients
Silver Spring, MD 20993–0002. Send Office of Management and Budget
regarding the manufacturing,
one self-addressed adhesive label to (OMB) under the Paperwork Reduction
preclinical, and clinical trial design
assist the office in processing your Act of 1995 (44 U.S.C. 3501–3520). The
issues for all phases of the clinical
requests. The draft guidance may also be collections of information in 21 CFR
development program. Such
obtained by mail by calling CBER at 1– part 50 have been approved under OMB
information is intended to assist
800–835–4709 or 240–402–8010. See control number 0910–0755; the sponsors in designing clinical
the SUPPLEMENTARY INFORMATION section collections of information in 21 CFR development programs for such
for electronic access to the draft part 58 have been approved under OMB products, where there may be limited
guidance document. control number 0910–0119; the study population size and potential
FOR FURTHER INFORMATION CONTACT: collections of information in 21 CFR feasibility and safety issues as well as
Angela Moy, Center for Biologics part 211 have been approved under issues relating to the interpretability of
Evaluation and Research, Food and OMB control number 0910–0139; the bioactivity/efficacy outcomes that may
Drug Administration, 10903 New collections of information in 21 CFR be unique to rare diseases or to the
Hampshire Ave., Bldg. 71, Rm. 7301, part 312 have been approved under nature of the GT product itself.
Silver Spring, MD 20993–0002, 240– OMB control number 0910–0014; the DATES: Submit either electronic or
402–7911. collections of information in 21 CFR written comments on the draft guidance
SUPPLEMENTARY INFORMATION: part 601 have been approved under by October 10, 2018 to ensure that the
OMB control number 0910–0338; the Agency considers your comment on this
I. Background collections of information in the draft guidance before it begins work on
FDA is announcing the availability of guidance entitled ‘‘Expedited Programs the final version of the guidance.
a draft document entitled ‘‘Human Gene for Serious Conditions—Drugs and ADDRESSES: You may submit comments
amozie on DSK3GDR082PROD with NOTICES1
Therapy for Retinal Disorders; Draft Biologics’’ have been approved under on any guidance at any time as follows:
Guidance for Industry.’’ The draft OMB control number 0910–0765; and
guidance provides recommendations to the collections of information in the Electronic Submissions
stakeholders developing GT products guidance entitled ‘‘Formal Meetings Submit electronic comments in the
for retinal disorders affecting adult and Between the FDA and Sponsors or following way:
pediatric patients. These disorders vary Applicants’’ have been approved under • Federal eRulemaking Portal:
in etiology, prevalence, diagnosis, and OMB control number 0910–0429. https://www.regulations.gov. Follow the
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![Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32305
collections of information in 21 CFR Dated: July 5, 2018. longer marketed and requested that the
part 58 have been approved under OMB Leslie Kux, approval of the applications be
control number 0910–0119; the Associate Commissioner for Policy. withdrawn.
collections of information in 21 CFR [FR Doc. 2018–14871 Filed 7–11–18; 8:45 am]
part 312 have been approved under DATES:Approval is withdrawn as of
BILLING CODE 4164–01–P
OMB control number 0910–0014; the August 13, 2018.
collections of information in 21 CFR FOR FURTHER INFORMATION CONTACT:
part 601 have been approved under DEPARTMENT OF HEALTH AND Florine P. Purdie, Center for Drug
OMB control number 0910–0338; the HUMAN SERVICES Evaluation and Research, Food and
collections of information in the Drug Administration, 10903 New
guidance entitled ‘‘Expedited Programs Food and Drug Administration Hampshire Ave., Bldg. 51, Rm. 6248,
for Serious Conditions—Drugs and Silver Spring, MD 20993–0002, 301–
[Docket No. FDA–2018–N–2180]
Biologics’’ have been approved under 796–3601.
OMB control number 0910–0765; and Concordia Pharmaceuticals, Inc., et al.;
the collections of information in the SUPPLEMENTARY INFORMATION: The
Withdrawal of Approval of 29 New
guidance entitled ‘‘Formal Meetings holders of the applications listed in the
Drug Applications
Between the FDA and Sponsors or table have informed FDA that these drug
Applicants’’ have been approved under AGENCY: Food and Drug Administration, products are no longer marketed and
OMB control number 0910–0429. HHS. have requested that FDA withdraw
ACTION: Notice. approval of the applications under the
III. Electronic Access process in § 314.150(c) (21 CFR
Persons with access to the internet SUMMARY: The Food and Drug 314.150(c)). The applicants have also,
may obtain the draft guidance at either Administration (FDA or Agency) is by their requests, waived their
https://www.fda.gov/BiologicsBlood withdrawing approval of 29 new drug opportunity for a hearing. Withdrawal
Vaccines/GuidanceCompliance applications (NDAs) from multiple of approval of an application or
RegulatoryInformation/Guidances/ applicants. The holders of the abbreviated application under
default.htm or https:// applications notified the Agency in § 314.150(c) is without prejudice to
www.regulations.gov. writing that the drug products were no refiling.
Application No. Drug Applicant
NDA 011287 ......... Kayexalate (sodium polystyrene sulfonate) Powder for Suspension, Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria
453.6 gram (g)/bottle. Dr., Lexington, KY 40504.
NDA 012249 ......... Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram Valeant Pharmaceuticals North America, LLC, 400 Somerset Cor-
(mg), 10 mg, and 25 mg. porate Blvd., Bridgewater, NJ 08807.
NDA 016211 ......... Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vial .... Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ
07936.
NDA 018674 ......... Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL) ............. B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109.
NDA 018852 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mg ...... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc., 425 Privet Rd., Horsham, PA 19044.
NDA 018854 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mg .... Do.
NDA 018988 ......... Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium) Novartis Pharmaceuticals Corp.
Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%.
NDA 019844 ......... Isolyte H in Dextrose 5% in Plastic Container Injection ......................... B. Braun Medical, Inc.
NDA 019870 ......... Isolyte M in Dextrose 5% in Plastic Container Injection ......................... Do.
NDA 019964 ......... Terazol 3 (terconazole) Vaginal Cream, 0.8% ........................................ Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd.,
Titusville, NJ 08560.
NDA 020000 ......... Dextrose 5% in Ringer’s in Plastic Container Injection .......................... B. Braun Medical, Inc.
NDA 020393 ......... Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/spray ............... Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT 06877–0368.
NDA 020394 ......... Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/spray ............... Do.
NDA 021180 ......... Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch, Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300,
0.035 mg/24 h; 0.15 mg/24 h. Raritan, NJ 08869–0602.
NDA 021633 ......... Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mg ..... Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,
2525 Dupont Dr., Irvine, CA 92612.
NDA 022033 ......... Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304.
and 150 mg.
NDA 022106 ......... Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vial ............ Shionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932.
NDA 022386 ......... PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500 Novo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536.
mg; 2 mg.
NDA 050201 ......... Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sul- Parkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd
fate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/g. St., New York, NY 10017.
NDA 050344 ......... Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, Alcon Laboratories, Inc., 6201 South Freeway, TC–45, Fort Worth, TX
EQ 3.5 mg base/g; 10,000 units/g. 76134.
NDA 050442 ......... Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
and EQ 100 mg base/vial.
NDA 050497 ......... Ticar (ticarcillin disodium) Injection, EQ 1 g base/vial, EQ 3 g base/ GlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426.
vial, EQ 6 g base/vial, EQ 20 g base/vial, and EQ 30 g base/vial.
NDA 050512 ......... Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and Warner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866.
amozie on DSK3GDR082PROD with NOTICES1
EQ 250 mg base.
NDA 050527 ......... Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125 Do.
mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
NDA 050593 ......... Eryc Sprinkles (erythromycin) Capsules, 125 mg ................................... Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045.
NDA 050646 ......... Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/ GlaxoSmithKline.
vial.
NDA 050668 ......... Lorabid (loracarbef) Capsules USP, 200 mg and 400 mg ..................... King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
NDA 050792 ......... Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and B. Braun Medical, Inc.
Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base.
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Document Created: 2018-11-06 10:22:37
Document Modified: 2018-11-06 10:22:37
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by October 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 32303 |
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