Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Prescription Drug Product Labeling; Medication Guide Requirements, 67762-67763 [2015-27945]

Download as PDF 67762 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993–0002, 301– 796–1500. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.’’ This guidance assists sponsors in all phases of drug development including nonclinical development, early phases of clinical development, phase 3 protocol designs, and endpoints for the treatment of HIV. This guidance specifically addresses HIV drug development in populations in need of additional HIV drugs for maintaining HIV suppression including trial designs for heavily treatmentexperienced patients (multiple-drugresistant patients with few remaining options); use of early virologic assessments as primary endpoints in trials evaluating antiretroviral drugs in heavily treatment-experienced patients; recommended trial durations based on medical need; and risk-benefit in the targeted patient population. This guidance finalizes the draft guidance of the same name published in the Federal Register June 5, 2013 (78 FR 33848), and replaces the guidance for industry entitled ‘‘Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval’’ issued October 2002. The public comments received on the draft guidance have been considered and the guidance has been revised to: ¨ (1) Clarify definitions of treatment-naıve and treatment-experienced patient categories with respect to both drug susceptibility and clinical history; (2) add recommendations for trial designs that investigate switching treatment regimens in patients who are suppressed on current therapy; and (3) briefly discuss recommendations for labeling claims for safety endpoints. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing antiretroviral drugs for the treatment of HIV infection. 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. VerDate Sep<11>2014 18:04 Nov 02, 2015 Jkt 238001 II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). 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 314 have been approved under OMB control number 0910–0001, and the collections of information referred to in the guidance for industry entitled ‘‘Establishment and Operation of Clinical Trial Data Monitoring Committees’’ have been approved under OMB control number 0910–0581. III. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: October 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27935 Filed 11–2–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0902] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Prescription Drug Product Labeling; Medication Guide Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 (the PRA). DATES: Fax written comments on the collection of information by December 3, 2015. 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, SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0393. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Prescription Drug Product Labeling; Medication Guide Requirements OMB Control Number 0910–0393—Extension FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drug and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA approved patient medication information. These Medication Guides inform patients about the most important information they should know about these products in order to use them safely and effectively. Included is information such as the drug’s approved uses, contraindications, adverse drug reactions, and cautions for specific populations, with a focus on why the particular product requires a Medication Guide. These regulations are intended to improve the public health by providing information necessary for patients to use certain medication safely and effectively. The regulations contain the following reporting requirements that are subject to the PRA: • 21 CFR 208.20—Applicants must submit draft Medication Guides for FDA approval according to the prescribed content and format. • 21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)—Application holders must submit changes to Medication Guides to FDA for prior approval as supplements to their applications. • 21 CFR 208.24(c)—Each distributor or packer that receives Medication Guides, or the means to produce Medication Guides, from a manufacturer under paragraph (b) of this section shall provide those Medication Guides to each authorized dispenser to whom it ships a container of drug product. E:\FR\FM\03NON1.SGM 03NON1 67763 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices • 21 CFR 208.24(e)—Each authorized dispenser of a prescription drug product for which a Medication Guide is required, when dispensing the product to a patient or to a patient’s agent, must provide a Medication Guide directly to each patient unless an exemption applies under 21 CFR 208.26. • 21 CFR 208.26(a)—Requests may be submitted for exemption or deferral from particular Medication Guide content or format requirements. In the Federal Register of May 29, 2015 (80 FR 30688), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment. One comment requested clarification of FDA’s burden estimates for 21 CFR 208.24(c)—how the burden estimates were calculated and clarification of the definitions of ‘‘respondent,’’ ‘‘average burden per respondent,’’ and ‘‘disclosures per respondent’’. The comment asked whether ‘‘respondent’’ means the total number of individual warehouses owned and operated by all wholesale distribution companies or the number of wholesale distribution companies (which have multiple warehouses). The comment asked whether ‘‘disclosures per respondent’’ includes every instance that a Medication Guide is provided with any drug in 1 year or if it means the number of different types of drugs that a distributor would sell in a year for which a manufacturer was required to develop and supply a Medication Guide. The comment said that the number of ‘‘disclosures per respondent’’ would vary greatly depending on whether the word ‘‘respondent’’ means individual warehouses or wholesale distribution companies. Concerning the burden hour estimates, the comment asked whether 1.25 hours (average burden per disclosure) includes the varying ways that wholesale distributors receive and distribute Medication Guides with shipments. The comment said that Medication Guides are provided to wholesale distributors from the manufacturer by multiple methods: For example, they are sometimes included with the package insert alone, provided in the package with the drug, or as loose leaf sheet(s) of paper and bulk-shipped to the wholesale distributor as a separate shipment or placed within the container in which the prescription product is shipped to the wholesale distributor. The comment said that if the Medication Guide is included on tear- off sheets or as loose-leaf paper, wholesale distributors would be responsible for coordinating the movement of those papers, taking significantly more time. FDA Response: FDA has used, in part, information previously provided by stakeholders to determine the burden estimates. The 191 respondents under 21 CFR 208.24(c) in table 2 refers to the number of distribution centers. The 1.25 hour estimate for the ‘‘average burden per respondent’’ includes considerations such as the burden to receive, process, copy, store, select, and ship Medication Guides. The burden is an average estimate to address the various scenarios for distributing Medication Guides including electronically and in paper format. The ‘‘disclosures per respondent’’ refers to the number of instances Medication Guides are provided to distributors in a format that is physically separate from the drug product and must be handled and processed separately. Because the comment did not indicate if the calculations were overestimated or underestimated, we continue to use 191 for the number of respondents, 9,000 for the number of disclosures per respondent, and 1.25 hours as the average burden per disclosure. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Content and Format of a Medication Guide—208.20 ......... Supplements and Other Changes to an Approved Application—314.70(b)(3)(ii), 601.12(f) ........................................ Exemptions and Deferrals—208.26(a) ................................ Total .............................................................................. 1 There Number of responses per respondent Number of respondents 21 CFR section Average burden per response Total annual responses Total hours 57 1 57 320 18,240 108 1 ........................ 1 1 ........................ 108 1 ........................ 72 4 ........................ 7,776 4 26,020 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 respondents 21 CFR Section Number of disclosures per respondent Average burden per disclosure Total annual disclosures Total hours 208.24(c) ........................................................................ Distributing and Dispensing a Medication Guide— 208.24(e) .................................................................... 191 9,000 1,719,000 1.25 2,148,750 88,736 5,000 443,680,000 22,184,000 Total ........................................................................ ........................ .............................. ........................ 0.05 (3 minutes) ........................ mstockstill on DSK4VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27945 Filed 11–2–15; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:04 Nov 02, 2015 Jkt 238001 PO 00000 Frm 00066 Fmt 4703 Sfmt 9990 E:\FR\FM\03NON1.SGM 03NON1 24,332,750

Agencies

[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67762-67763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27945]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]

Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; Prescription
Drug Product Labeling; Medication Guide Requirements

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 (the PRA).

DATES: Fax written comments on the collection of information by
December 3, 2015.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0393.
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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

Prescription Drug Product Labeling; Medication Guide Requirements OMB
Control Number 0910-0393--Extension

FDA regulations require the distribution of patient labeling,
called Medication Guides, for certain prescription human drug and
biological products used primarily on an outpatient basis that pose a
serious and significant public health concern requiring distribution of
FDA approved patient medication information. These Medication Guides
inform patients about the most important information they should know
about these products in order to use them safely and effectively.
Included is information such as the drug's approved uses,
contraindications, adverse drug reactions, and cautions for specific
populations, with a focus on why the particular product requires a
Medication Guide. These regulations are intended to improve the public
health by providing information necessary for patients to use certain
medication safely and effectively.
The regulations contain the following reporting requirements that
are subject to the PRA:
21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA approval according to the prescribed content and format.
21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application
holders must submit changes to Medication Guides to FDA for prior
approval as supplements to their applications.
21 CFR 208.24(c)--Each distributor or packer that receives
Medication Guides, or the means to produce Medication Guides, from a
manufacturer under paragraph (b) of this section shall provide those
Medication Guides to each authorized dispenser to whom it ships a
container of drug product.

[[Page 67763]]

21 CFR 208.24(e)--Each authorized dispenser of a
prescription drug product for which a Medication Guide is required,
when dispensing the product to a patient or to a patient's agent, must
provide a Medication Guide directly to each patient unless an exemption
applies under 21 CFR 208.26.
21 CFR 208.26(a)--Requests may be submitted for exemption
or deferral from particular Medication Guide content or format
requirements.
In the Federal Register of May 29, 2015 (80 FR 30688), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
One comment requested clarification of FDA's burden estimates for
21 CFR 208.24(c)--how the burden estimates were calculated and
clarification of the definitions of ``respondent,'' ``average burden
per respondent,'' and ``disclosures per respondent''. The comment asked
whether ``respondent'' means the total number of individual warehouses
owned and operated by all wholesale distribution companies or the
number of wholesale distribution companies (which have multiple
warehouses). The comment asked whether ``disclosures per respondent''
includes every instance that a Medication Guide is provided with any
drug in 1 year or if it means the number of different types of drugs
that a distributor would sell in a year for which a manufacturer was
required to develop and supply a Medication Guide. The comment said
that the number of ``disclosures per respondent'' would vary greatly
depending on whether the word ``respondent'' means individual
warehouses or wholesale distribution companies.
Concerning the burden hour estimates, the comment asked whether
1.25 hours (average burden per disclosure) includes the varying ways
that wholesale distributors receive and distribute Medication Guides
with shipments. The comment said that Medication Guides are provided to
wholesale distributors from the manufacturer by multiple methods: For
example, they are sometimes included with the package insert alone,
provided in the package with the drug, or as loose leaf sheet(s) of
paper and bulk-shipped to the wholesale distributor as a separate
shipment or placed within the container in which the prescription
product is shipped to the wholesale distributor. The comment said that
if the Medication Guide is included on tear-off sheets or as loose-leaf
paper, wholesale distributors would be responsible for coordinating the
movement of those papers, taking significantly more time.
FDA Response: FDA has used, in part, information previously
provided by stakeholders to determine the burden estimates. The 191
respondents under 21 CFR 208.24(c) in table 2 refers to the number of
distribution centers. The 1.25 hour estimate for the ``average burden
per respondent'' includes considerations such as the burden to receive,
process, copy, store, select, and ship Medication Guides. The burden is
an average estimate to address the various scenarios for distributing
Medication Guides including electronically and in paper format. The
``disclosures per respondent'' refers to the number of instances
Medication Guides are provided to distributors in a format that is
physically separate from the drug product and must be handled and
processed separately. Because the comment did not indicate if the
calculations were overestimated or underestimated, we continue to use
191 for the number of respondents, 9,000 for the number of disclosures
per respondent, and 1.25 hours as the average burden per disclosure.

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Content and Format of a 57 1 57 320 18,240
Medication Guide--208.20.......
Supplements and Other Changes to 108 1 108 72 7,776
an Approved Application--
314.70(b)(3)(ii), 601.12(f)....
Exemptions and Deferrals-- 1 1 1 4 4
208.26(a)......................
Total....................... .............. .............. .............. .............. 26,020
----------------------------------------------------------------------------------------------------------------
\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
21 CFR Section Number of disclosures per Total annual burden per Total hours
respondents respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
208.24(c).................... 191 9,000 1,719,000 1.25 2,148,750
Distributing and Dispensing a 88,736 5,000 443,680,000 0.05 (3 22,184,000
Medication Guide--208.24(e). minutes)
Total.................... .............. ................. .............. .............. 24,332,750
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Dated: October 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27945 Filed 11-2-15; 8:45 am]
BILLING CODE 4164-01-P

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