80 FR 49240 - Botanical Drug Development; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 158 (August 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 158 (August 17, 2015)
| Page Range | 49240-49242 | |
| FR Document | 2015-20230 |
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)] [Notices] [Pages 49240-49242] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20230] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0103] Botanical Drug Development; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. [[Page 49241]] ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Botanical Drug Development.'' This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This draft guidance revises the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 16, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4144, Silver Spring, MD 20993-0002, 301-796-2905, Sau.Lee@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Botanical Drug Development.'' This guidance describes the Center for Drug Evaluation and Research's current thinking on appropriate development plans for botanical drugs to be submitted in NDAs and specific recommendations on submitting INDs in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the OTC drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under BLAs, many scientific principles described in this guidance may also apply to these products. This guidance specifically discusses several areas in which, due to the unique nature of botanical drugs, the Agency finds it appropriate to apply regulatory policies that differ from those applied to nonbotanical drugs, such as synthetic, semi-synthetic, or otherwise highly purified or chemically modified drugs, including antibiotics derived from microorganisms. Because this guidance focuses on considerations unique to botanical drugs, policies and recommendations applicable to both botanical and nonbotanical drugs are generally not covered in this document. This guidance revises the final guidance for industry entitled ``Botanical Drug Products'' issued in June 2004. The general approach to botanical drug development has remained unchanged since that time; however, based on improved understanding of botanical drugs and experience acquired in the reviews of NDAs and INDs for these drugs, specific recommendations have been modified and new sections have been added to better address late-phase development and NDA submission for botanical drugs. 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 Agency's current thinking on botanical drug development. 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. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are 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 guidance explains the circumstances under which FDA regulations require approval of an NDA for marketing a botanical drug product and when such a product may be marketed under an OTC drug monograph. The regulations governing the preparation and submission of an NDA are in part 314 (21 CFR part 314), and the guidance does not contain any recommendations that exceed the requirements of these regulations. FDA has estimated the information collection requirements resulting from the preparation and submission of an NDA, and OMB has approved the burden under OMB control number 0910-0001. FDA anticipates that any NDAs submitted for botanical drug products would be included under the burden estimates approved by OMB for part 314. The regulations on the procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing OTC drug monographs, are set forth in Sec. 330.10 (21 CFR 330.10). FDA believes that any botanical drug products that may be eligible for inclusion in an OTC drug monograph under current Sec. 330.10 have already been or presently are being considered for such inclusion. The guidance also provides scientific and regulatory guidance to sponsors on conducting clinical investigations of botanical drugs. The regulations governing the preparation and submission of INDs are in part 312 (21 CFR part 312). The guidance does not contain any recommendations that exceed the requirements in those regulations. FDA has estimated the information collection requirements resulting from the preparation and submission of an IND under part 312, and OMB has approved the reporting and recordkeeping burden under OMB control number 0910-0014. [[Page 49242]] IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: August 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20230 Filed 8-14-15; 8:45 am] BILLING CODE 4164-01-P
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administers or that has the authority to small size, use this information to pertinent personally identifiable
investigate potential fraud, waste or deduce the identity of the beneficiary). information (encrypted and properly
abuse in a health benefits program Note: Information collected or obtained transmitted) to be used for retrieval of
funded in whole or in part by Federal under § 1860D–15 (i.e., risk adjustment data their records (i.e., NPI or Health
funds, when disclosure is deemed used to pay Part D plan sponsors) will be Insurance Claim Number).
reasonably necessary by CMS to used and disclosed only in accordance with
the statutory limitations under § 1860D– RECORD ACCESS PROCEDURE:
prevent, deter, discover, detect,
investigate, examine, prosecute, sue 15(f)(2). Individuals seeking access to records
with respect to, defend against, correct, about them in this system should follow
remedy, or otherwise combat fraud, POLICIES AND PRACTICES FOR STORING, the same instructions indicated under
RETRIEVING, ACCESSING, RETAINING, AND ‘‘Notification Procedure’’ and
waste or abuse in such programs.
DISPOSING OF RECORDS IN THE SYSTEMSTORAGE: reasonably specify the record content
7. To assist Medicare Advantage
Archived records will be stored on being sought. (These procedures are in
organizations, Part D Sponsors and
magnetic tapes. Data that is currently in accordance with Department regulation
PACE organizations with improving the
use is stored in the RAPS database. 45 CFR 5b.5(a)(2)).
quality of required risk adjustment data
obtained from the provider that RETRIEVABILITY: CONTESTING RECORD PROCEDURES:
furnished the item or service. CMS will Records will be retrieved by National Individuals seeking to contest the
be analyzing the data received and Provider Identifier (NPI), beneficiary content of information about them in
advising MA organizations, Part D provider name, or beneficiary Health this system should follow the same
Sponsors and PACE organizations of Insurance Claim Number. instructions indicated under
trends and data analysis results to help ‘‘Notification Procedure.’’ The request
improve the accuracy and completeness SAFEGUARDS:
should: reasonably identify the record
of data received from the provider. Personnel having access to the system
and specify the information being
8. To assist appropriate Federal have been trained in the Privacy Act
contested; state the corrective action
agencies and CMS contractors and and information security requirements.
sought; and provide the reasons for the
consultants that have a need to know Employees who maintain records in this
correction, with supporting justification.
the information for the purpose of system are instructed not to release data
(These procedures are in accordance
assisting CMS’ efforts to respond to a until the intended recipient agrees to
with Department regulation 45 CFR
suspected or confirmed breach of the implement appropriate management,
5b.7.)
security or confidentiality of operational, and technical safeguards
information maintained in this system sufficient to protect the confidentiality, RECORD SOURCE CATEGORIES:
of records, provided that the integrity and availability of the RASS processes data extracted from
information disclosed is relevant and information and information systems; RAPS and RAS IT systems to calculate
necessary for that assistance. and to prevent unauthorized access. the risk scores used to adjust payments
Access to records in the RASS will be to Medicare Advantage organizations,
Note: CMS may disclose information from
this system of records, without the individual
limited to CMS personnel and Part D plan sponsors and PACE plans.
record subject’s consent, for any of the contractors through password security, RAS receives the most current data for
following purposes referenced directly in the encryption, firewalls, and secured each Medicare Part C and Part D
Privacy Act: 5 U.S.C. 552a(b)(1), (3)–(8), and operating system(s). beneficiary from the following sources:
(12). CMS must also disclose information RAPS, Common Medicare Environment
RETENTION AND DISPOSAL:
from this system of records, without the (CME) also known as Medicare
individual record subject’s consent, for any Records (i.e., enrollee diagnosis data
Beneficiary Database (MBD/CME), and
of the following purposes referenced directly files created in RAPS, and Risk
in the Privacy Act: 5 U.S.C. 552a(b)(2), and National Medicare Utilization Database
Adjustment Factor (RAF) files created in
(b)(9)–(11). (NMUD). RAPS receives risk adjustment
RAS) will be maintained for a period of
data from MA organizations and other
up to 10 years after date of creation. Any
entities defined above.
ADDITIONAL PROVISIONS AFFECTING ROUTINE USE such records that are needed longer,
DISCLOSURES: such as to resolve claims and audit SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
This system contains Protected Health exceptions or to prosecute fraud, will be OF THE ACT:
Information (PHI) as defined by HHS retained until such matters are resolved. None.
regulation ‘‘Standards for Privacy of Enrollee claims records are currently
subject to a document preservation Celeste Dade-Vinson,
Individually Identifiable Health
order and will be preserved indefinitely Health Insurance Specialist, Centers for
Information’’ (45 CFR parts 160 and 164,
pending further notice from the U.S. Medicare & Medicaid Services.
65 FR 82462 (12–28–00), subparts A and
Department of Justice (DOJ). [FR Doc. 2015–20224 Filed 8–14–15; 8:45 am]
E). Disclosures of PHI authorized by
BILLING CODE 4120–03–P
these routine uses may only be made if, SYSTEM MANAGER AND ADDRESS:
and as, permitted or required by the
Director, Division of Encounter Data
‘‘Standards for Privacy of Individually
and Risk Adjustment Operations, DEPARTMENT OF HEALTH AND
Identifiable Health Information.’’
Medicare Plan Payment Group, Center HUMAN SERVICES
In addition, our policy will be to for Medicare, CMS, 7500 Security
mstockstill on DSK4VPTVN1PROD with NOTICES
prohibit release even of data that is not Boulevard, Baltimore, Maryland 21244– Food and Drug Administration
directly identifiable, except if required 1850.
by law, if we determine there is a [Docket No. FDA–2000–D–0103]
possibility that an individual can be NOTIFICATION PROCEDURE:
Botanical Drug Development; Draft
identified through implicit deduction Individuals (i.e., the beneficiary or Guidance for Industry; Availability
based on small cell sizes (instances provider) wishing to know if this system
where the patient population is so small contains records about them should AGENCY: Food and Drug Administration,
that individuals could, because of the write to the system manager and include HHS.
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IV. Electronic Access to obtain detailed requirements, please ‘‘longitudinal’’ information about
Persons with access to the Internet refer to the full FOA located at individual patients is invaluable to the
may obtain the document at either www.grants.gov. Search by Funding design of a drug development program.
http://www.fda.gov/Drugs/ Opportunity Number: RFA–FD–15–038. The rare disease community is in need
GuidanceCompliance SUPPLEMENTARY INFORMATION: of a means of collecting and analyzing
RegulatoryInformation/Guidances/ this knowledge: A natural history
I. Funding Opportunity Description database tool.
default.htm or http://
www.regulations.gov. RFA–FD–15–038
93.103 B. Research Objectives
Dated: August 12, 2015.
A. Background The development of natural history
Leslie Kux,
There are an estimated 7,000 rare databases will directly further FDA’s
Associate Commissioner for Policy. public health mission. We anticipate
[FR Doc. 2015–20230 Filed 8–14–15; 8:45 am] diseases, in total affecting
approximately 30 million Americans. that the successful implementation of a
BILLING CODE 4164–01–P
Most of these are serious conditions natural history database will have
with no approved therapies. Rare profound and far-reaching effects on
diseases constitute an enormous unmet development of therapies for rare
DEPARTMENT OF HEALTH AND diseases. As a basis for solid natural
HUMAN SERVICES medical need.
Drug development for rare diseases, as history knowledge of a disease it may
Food and Drug Administration well as for common diseases, relies on help to make a clinical development
an indepth knowledge of the diseases’ program for a candidate therapy appear
[Docket No. FDA–2015–N–0012] natural histories. Natural history is the feasible, and thus a more attractive area
course of the disease in the absence of to pharmaceutical companies for
Disease Natural History Database devoting a portion of their drug
a clinical intervention (that is, treatment
Development—(U24) discovery resources. This too will lead
under clinical care or study). Natural
AGENCY: Food and Drug Administration, history knowledge makes possible the to greater numbers of therapies for rare
HHS. design of successful and efficient drug diseases.
ACTION: Notice. development programs. This knowledge C. Eligibility Information
has wide-ranging applications at every
SUMMARY: The Food and Drug stage of drug development, for example, Only the following organization is
Administration (FDA) is announcing the insight into the mechanism of disease, eligible to apply: The National
availability of grant funds for the which can inform proof-of-concept Organization for Rare Disorders. NORD
support of Natural History Database studies; development of biomarkers that is uniquely qualified to apply for this
Development. The National can expedite clinical studies at every grant as the only applicant. Natural
Organization for Rare Disorders (NORD) stage of drug development; recognition history studies is an area of unmet need
is developing an Internet-based data and understanding of phenotypes of and there are very few efforts towards
collection tool with promise to further disease that may respond more (or less) building these studies. Those efforts that
the accumulation of natural history data to a therapy; and knowledge of the exist are very limited to specific
for many rare diseases. The goal of this aspects of disease that matter to diseases (e.g., cystic fibrosis, urea cycle
grant is to enable NORD to further patients, with an impact on developing disorders). These individual efforts
develop, refine, and disseminate the drugs that have a meaningful impact on cannot and do not support other patient
database tool. how a patient feels, functions, or groups starting their own studies. Most
DATES: Important dates are as follows: survives. The lack of natural history efforts are largely focused on patient
1. The application due date is knowledge can result in the failure of communication and patient reports
September 4, 2015. drug programs, even for drugs with great through Web-based self-reporting and
2. The anticipated start date is promise. Unfortunately, the natural are not likely to conform to sufficient
September 2015. history of rare diseases is often poorly scientific rigor to be able to support
3. The opening date is July 2015. understood. drug development. Although patient
4. The expiration date is September 5, Impediments to the understanding of registries exist, these are not the same
2015. the natural history of a rare disease thing as natural history studies, and can
ADDRESSES: Submit electronic include the small numbers of patients often be very broad and general and
applications to: http://www.grants.gov. and the sparse dispersal of clinical cannot be customized to the depth and
For more information, see section III of experience even among the chief scope needed to support multiple
the SUPPLEMENTARY INFORMATION section clinical referral centers. The rare disease natural history studies in a diverse
of this notice. community is largely composed of group of rare diseases. The rigor, scope,
FOR FURTHER INFORMATION CONTACT: small, diverse groups including patient and flexibility of NORD’s platform,
James Kaiser, Office of Translational and patient-family support, nonprofit which comes from approximately 15
Sciences, Center for Drug Evaluation disease groups (including umbrella years of working with the rare disease
and Research, Food and Drug groups), academic researchers, and community on these efforts, is unique
Administration, 10903 New Hampshire small- to medium-sized biotechnology and directly suited to the needs of FDA.
Ave., Silver Spring, MD 20993, 301– and pharmaceutical companies. For
II. Award Information/Funds Available
mstockstill on DSK4VPTVN1PROD with NOTICES
796–1237, james.kaiser@fda.hhs.gov. most rare diseases there has been no
Vieda Hubbard, Office of Acquisition mechanism to systematically collect rare A. Award Amount
and Grants Services, Food and Drug disease knowledge. In addition, it has
Administration, 5630 Fishers Lane, become increasingly clear that it is FDA/Center for Drug Evaluation and
Rockville, MD 20857, 240–402–7588, vitally important to collect more Research intends to fund up to
Vieda.Hubbard@fda.hhs.gov. knowledge from living patients over $250,000, for fiscal year 2015 in support
For more information on this funding time, not simply to collect currently of this grant program. It is anticipated
opportunity announcement (FOA) and available information. This that one award will be made, not to
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Document Created: 2015-12-15 11:06:27
Document Modified: 2015-12-15 11:06:27
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 16, 2015. | |
| Contact | Sau L. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4144, Silver Spring, MD 20993-0002, 301-796-2905, [email protected] | |
| FR Citation | 80 FR 49240 |
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