80 FR 67762 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Prescription Drug Product Labeling; Medication Guide Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 212 (November 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 212 (November 3, 2015)
| Page Range | 67762-67763 | |
| FR Document | 2015-27945 |
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)] [Notices] [Pages 67762-67763] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27945] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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
![67762 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices
FOR FURTHER INFORMATION CONTACT: II. The Paperwork Reduction Act of OMB, Attn: FDA Desk Officer, FAX:
Jeffrey Murray, Center for Drug 1995 202–395–7285, or emailed to oira_
Evaluation and Research, Food and This guidance refers to previously submission@omb.eop.gov. All
Drug Administration, 10903 New approved collections of information that comments should be identified with the
Hampshire Ave., Bldg. 22, Rm. 6360, are subject to review by the Office of OMB control number 0910–0393. Also
Silver Spring, MD 20993–0002, 301– Management and Budget under the include the FDA docket number found
796–1500. Paperwork Reduction Act of 1995 (44 in brackets in the heading of this
SUPPLEMENTARY INFORMATION: U.S.C. 3501–3520). The collections of document.
I. Background information in 21 CFR part 312 have FOR FURTHER INFORMATION CONTACT: FDA
been approved under OMB control PRA Staff, Office of Operations, Food
FDA is announcing the availability of number 0910–0014, the collections of and Drug Administration, 8455
a guidance for industry entitled information in 21 CFR part 314 have Colesville Rd., COLE–14526, Silver
‘‘Human Immunodeficiency Virus-1 been approved under OMB control Spring, MD 20993–0002, PRAStaff@
Infection: Developing Antiretroviral number 0910–0001, and the collections fda.hhs.gov.
Drugs for Treatment.’’ This guidance of information referred to in the
assists sponsors in all phases of drug guidance for industry entitled SUPPLEMENTARY INFORMATION: In
development including nonclinical ‘‘Establishment and Operation of compliance with 44 U.S.C. 3507, FDA
development, early phases of clinical Clinical Trial Data Monitoring has submitted the following proposed
development, phase 3 protocol designs, Committees’’ have been approved under collection of information to OMB for
and endpoints for the treatment of HIV. OMB control number 0910–0581. review and clearance.
This guidance specifically addresses Prescription Drug Product Labeling;
HIV drug development in populations III. Electronic Access
Medication Guide Requirements OMB
in need of additional HIV drugs for Persons with access to the Internet Control Number 0910–0393—Extension
maintaining HIV suppression including may obtain the guidance at either
trial designs for heavily treatment- http://www.fda.gov/Drugs/Guidance FDA regulations require the
experienced patients (multiple-drug- ComplianceRegulatoryInformation/ distribution of patient labeling, called
resistant patients with few remaining Guidances/default.htm or http:// Medication Guides, for certain
options); use of early virologic www.regulations.gov. prescription human drug and biological
assessments as primary endpoints in products used primarily on an
Dated: October 28, 2015.
trials evaluating antiretroviral drugs in outpatient basis that pose a serious and
Leslie Kux,
heavily treatment-experienced patients; significant public health concern
Associate Commissioner for Policy. requiring distribution of FDA approved
recommended trial durations based on
[FR Doc. 2015–27935 Filed 11–2–15; 8:45 am] patient medication information. These
medical need; and risk-benefit in the
targeted patient population. BILLING CODE 4164–01–P Medication Guides inform patients
This guidance finalizes the draft about the most important information
guidance of the same name published in they should know about these products
DEPARTMENT OF HEALTH AND in order to use them safely and
the Federal Register June 5, 2013 (78 FR
HUMAN SERVICES effectively. Included is information such
33848), and replaces the guidance for
industry entitled ‘‘Antiretroviral Drugs as the drug’s approved uses,
Food and Drug Administration
Using Plasma HIV RNA contraindications, adverse drug
Measurements—Clinical Considerations [Docket No. FDA–2011–N–0902] reactions, and cautions for specific
for Accelerated and Traditional populations, with a focus on why the
Agency Information Collection particular product requires a Medication
Approval’’ issued October 2002.
Activities; Proposed Collection; Guide. These regulations are intended to
The public comments received on the
Submission for Office of Management improve the public health by providing
draft guidance have been considered
and Budget Review; Prescription Drug information necessary for patients to use
and the guidance has been revised to:
Product Labeling; Medication Guide certain medication safely and
(1) Clarify definitions of treatment-naı̈ve
Requirements effectively.
and treatment-experienced patient
categories with respect to both drug AGENCY: Food and Drug Administration, The regulations contain the following
susceptibility and clinical history; (2) HHS. reporting requirements that are subject
add recommendations for trial designs ACTION: Notice. to the PRA:
that investigate switching treatment • 21 CFR 208.20—Applicants must
regimens in patients who are SUMMARY: The Food and Drug submit draft Medication Guides for FDA
suppressed on current therapy; and (3) Administration (FDA) is announcing approval according to the prescribed
briefly discuss recommendations for that a proposed collection of content and format.
labeling claims for safety endpoints. information has been submitted to the • 21 CFR 314.70(b)(3)(ii) and 21 CFR
This guidance is being issued Office of Management and Budget 601.12(f)—Application holders must
consistent with FDA’s good guidance (OMB) for review and clearance under submit changes to Medication Guides to
practices regulation (21 CFR 10.115). the Paperwork Reduction Act of 1995 FDA for prior approval as supplements
The guidance represents the current (the PRA). to their applications.
DATES: Fax written comments on the • 21 CFR 208.24(c)—Each distributor
mstockstill on DSK4VPTVN1PROD with NOTICES
thinking of FDA on developing
antiretroviral drugs for the treatment of collection of information by December or packer that receives Medication
HIV infection. It does not establish any 3, 2015. Guides, or the means to produce
rights for any person and is not binding ADDRESSES: To ensure that comments on Medication Guides, from a manufacturer
on FDA or the public. You can use an the information collection are received, under paragraph (b) of this section shall
alternative approach if it satisfies the OMB recommends that written provide those Medication Guides to
requirements of the applicable statutes comments be faxed to the Office of each authorized dispenser to whom it
and regulations. Information and Regulatory Affairs, ships a container of drug product.
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![Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices 67763
• 21 CFR 208.24(e)—Each authorized includes every instance that a off sheets or as loose-leaf paper,
dispenser of a prescription drug product Medication Guide is provided with any wholesale distributors would be
for which a Medication Guide is drug in 1 year or if it means the number responsible for coordinating the
required, when dispensing the product of different types of drugs that a movement of those papers, taking
to a patient or to a patient’s agent, must distributor would sell in a year for significantly more time.
provide a Medication Guide directly to which a manufacturer was required to FDA Response: FDA has used, in part,
each patient unless an exemption develop and supply a Medication information previously provided by
applies under 21 CFR 208.26. Guide. The comment said that the stakeholders to determine the burden
• 21 CFR 208.26(a)—Requests may be number of ‘‘disclosures per respondent’’ estimates. The 191 respondents under
submitted for exemption or deferral would vary greatly depending on 21 CFR 208.24(c) in table 2 refers to the
from particular Medication Guide whether the word ‘‘respondent’’ means number of distribution centers. The 1.25
content or format requirements. individual warehouses or wholesale hour estimate for the ‘‘average burden
In the Federal Register of May 29, distribution companies. per respondent’’ includes
2015 (80 FR 30688), FDA published a Concerning the burden hour considerations such as the burden to
60-day notice requesting public estimates, the comment asked whether receive, process, copy, store, select, and
comment on the proposed collection of 1.25 hours (average burden per ship Medication Guides. The burden is
information. FDA received one disclosure) includes the varying ways an average estimate to address the
comment. that wholesale distributors receive and various scenarios for distributing
One comment requested clarification distribute Medication Guides with Medication Guides including
of FDA’s burden estimates for 21 CFR shipments. The comment said that electronically and in paper format. The
208.24(c)—how the burden estimates Medication Guides are provided to ‘‘disclosures per respondent’’ refers to
were calculated and clarification of the wholesale distributors from the the number of instances Medication
definitions of ‘‘respondent,’’ ‘‘average manufacturer by multiple methods: For Guides are provided to distributors in a
burden per respondent,’’ and example, they are sometimes included format that is physically separate from
‘‘disclosures per respondent’’. The with the package insert alone, provided the drug product and must be handled
comment asked whether ‘‘respondent’’ in the package with the drug, or as loose and processed separately. Because the
means the total number of individual leaf sheet(s) of paper and bulk-shipped comment did not indicate if the
warehouses owned and operated by all to the wholesale distributor as a calculations were overestimated or
wholesale distribution companies or the separate shipment or placed within the underestimated, we continue to use 191
number of wholesale distribution container in which the prescription for the number of respondents, 9,000 for
companies (which have multiple product is shipped to the wholesale the number of disclosures per
warehouses). The comment asked distributor. The comment said that if the respondent, and 1.25 hours as the
whether ‘‘disclosures per respondent’’ Medication Guide is included on tear- average burden per disclosure.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
Content and Format of a Medication Guide—208.20 ......... 57 1 57 320 18,240
Supplements and Other Changes to an Approved Applica-
tion—314.70(b)(3)(ii), 601.12(f) ........................................ 108 1 108 72 7,776
Exemptions and Deferrals—208.26(a) ................................ 1 1 1 4 4
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
Number of Total annual
21 CFR Section disclosures burden per Total hours
respondents disclosures
per respondent disclosure
208.24(c) ........................................................................ 191 9,000 1,719,000 1.25 2,148,750
Distributing and Dispensing a Medication Guide—
208.24(e) .................................................................... 88,736 5,000 443,680,000 0.05 (3 22,184,000
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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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Document Created: 2018-03-01 11:32:19
Document Modified: 2018-03-01 11:32:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 3, 2015. | |
| 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 | 80 FR 67762 |
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