Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements, 24961-24962 [2012-10022]

Download as PDF Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices Kimberly S. Lane, Deputy Director, Office of Science Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–10035 Filed 4–25–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0902] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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 May 29, 2012. SUMMARY: 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–7651, juanmanuel.vilela@fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. tkelley on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Prescription Drug Product Labeling; Medication Guide Requirements (OMB Control Number 0910–0393)—Extension FDA regulations require the distribution of patient labeling, called VerDate Mar<15>2010 17:51 Apr 25, 2012 Jkt 226001 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. The estimates for the burden hours imposed by the following regulations are listed in table 1 of this document: • 21 CFR 208.20—Applicants must submit draft Medication Guides for FDA approval according to the prescribed content and format. • 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. • 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. In the Federal Register of December 21, 2011 (76 FR 79194), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received the following comments: (Comment 1) One comment states that FDA’s hourly burden estimate of 3 minutes per Medication Guide for pharmacists to comply with the requirements is miscalculated, although more in line with current practices versus previous FDA estimates. (Response) Because the comment did not indicate if the miscalculation was over-or under-estimated or provide alternative burden estimates for pharmacy time associated with distribution of a Medication Guide, we continue to use 3 minutes as the PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 24961 estimated burden for pharmacists to distribute Medication Guides to patients. (Comment 2) One comment said that there are distributor costs to comply with the Medication Guide requirements and FDA’s estimate omits § 208.24(c), which provides that ‘‘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, or the means to produce Medication Guides, to each authorized dispenser to whom it ships a container of drug product.’’ The comment states that the December 21, 2011, notice of proposed information collection (76 FR 79194) does not include an estimate for the reporting requirements of § 208.24(c) and that the requirement should be included in FDA’s assessment. (Response) FDA has re-evaluated § 208.24(c) with regards to information collection burden on distributors and packers and determined that § 208.24(c) does not contain an additional collection of information subject to the reporting requirements of the PRA. A ‘‘collection of information’’ includes an Agency request or requirement that members of the public submit reports, keep records, or provide information to third parties or the public by or for an Agency. Therefore, the manufacturer is responsible for providing information to third parties (§ 208.24(a)), i.e., Medication Guides, and the distributor or packer distributes the Medication Guides with the shipment of drugs to the dispensers. Thus, § 208.24(c) is not subject to the reporting requirements of the PRA. (Comment 3) One comment says that FDA should reassess the need to provide Medication Guides with each prescription refill and states there are situations where it is not necessary due to certain circumstances. The comment states that Medication Guides should be a tool to enhance the level of care to consumers, rather than a hindrance to pharmacists in their ability to provide quality patient care. (Response) FDA agrees and directs the comment to the guidance made available to the public entitled ‘‘Medication Guides—Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).’’ In this guidance, FDA articulates the circumstances under which FDA intends to exercise enforcement discretion regarding the requirement to provide Medication Guides in certain settings. E:\FR\FM\26APN1.SGM 26APN1 24962 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices (Comment 4) One comment states that Medication Guides increasingly become accessible online for download and print and the costs for printing, including paper, toner, administrative, and software costs, have shifted from the manufacturers to the pharmacies. (Response) While Medication Guides are increasingly available online for download and printing, the FDA does not agree that a financial and acquisition burden has shifted to or been created for dispensers. The comment mischaracterizes the cost to dispensers associated with the distribution of Medication Guides. For purposes of information collection requests under the PRA, capital costs are costs for equipment, machinery, and construction that, if not for FDA’s request or requirement, the respondent would not incur. Capital costs do not include costs to achieve regulatory compliance. The costs presented by the comment are not capital costs because they are costs associated with achieving regulatory compliance with requirements of the FD&C Act, not costs associated specifically with equipment, machinery, and construction needed to retain appropriate substantiating evidence. (Comment 5) One comment states that the length of Medication Guides continues to be burdensome and hinders a pharmacist from utilizing a potentially effective tool. The comment stresses the need for a succinct, onepage document that can be easily integrated into current pharmacy practice workflow. (Response) FDA generally agrees with the comment and is currently in the process of evaluating whether a onepage solution can be implemented. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondent 208.20 .................................... 314.70(b)(3)(ii), 601.12(f) ...... 208.24(e) ............................... 208.26(a) ............................... 25 5 59,000 1 1 1 5,000 1 Total ............................... ........................ ........................ 1 There Total hours 25 5 295 million 1 320 72 3 minutes 4 8,000 360 14,750,000 4 ............................................... ............................................... 14,758,364 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 20, 2012. Leslie Kux, Assistant Commissioner for Policy. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: [FR Doc. 2012–10022 Filed 4–25–12; 8:45 am] BILLING CODE 4160–01–P Proposed Project: Assessing Factors That Impact AIDS Drug Assistance Program (ADAP) Enrollment and Management in the Face of ADAP Waiting Lists (OMB No. 0915–xxxx)— [New] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1984. tkelley on DSK3SPTVN1PROD with NOTICES Average burden per response Total annual responses HRSA’s AIDS Drug Assistance Program (ADAP) provides assistance to help low-income, uninsured and underinsured individuals living with HIV/AIDS get access to life-saving medications. As part of the Ryan White HIV/AIDS Program, ADAP is the payer of last resort. Clients enrolled in ADAP have exhausted all other resources to obtain necessary medications and care. In recent years, ADAP has experienced an increase in enrollment while funding resources have decreased. This study will use case study methods to identify and examine factors that contribute to the rising enrollments in ADAP and States’ abilities to meet demands for ADAP services. Data Number of respondents Activity ADAP Site Visit Coordination .......................... Instrument: ADAP Personnel Interview ....................... State HIV/AIDS Lead Interview ................ VerDate Mar<15>2010 17:51 Apr 25, 2012 Jkt 226001 PO 00000 Responses per respondent collection will include interviews with up to eight respondents in each of eight selected states, for a maximum of 64 total respondents. Each interview will last approximately one and a half hours. The respondents fall into three general categories—ADAP personnel, State HIV/ AIDS program leads, and personnel from related State and local programs such as Medicaid and pharmacy assistance programs. Interviews will be conducted over a period of two and a half months. The proposed study will assess factors that may contribute to the rise in ADAP enrollment and costs such as new HIV cases, earlier use of antiretroviral medications, lower attrition of existing clients, unemployment and loss of insurance, or increasing drug costs. In addition, the study will examine factors that may decrease ADAP costs such as health care reform and cost containment strategies. Findings from the study will be used to develop policy and to recommend promising practices for managing ADAPs. The annual estimate of burden is as follows: Total responses Hours per response Total burden hours 8 8 1 8 32 8 Frm 00038 1 1 1 32 8 1.5 1.5 48 12 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1

Agencies

[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24961-24962]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10022]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 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 May 29,
2012.

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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@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. The estimates for the burden hours imposed by
the following regulations are listed in table 1 of this document:
21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA approval according to the prescribed content and format.
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.
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.
In the Federal Register of December 21, 2011 (76 FR 79194), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received the following comments:
(Comment 1) One comment states that FDA's hourly burden estimate of
3 minutes per Medication Guide for pharmacists to comply with the
requirements is miscalculated, although more in line with current
practices versus previous FDA estimates.
(Response) Because the comment did not indicate if the
miscalculation was over-or under-estimated or provide alternative
burden estimates for pharmacy time associated with distribution of a
Medication Guide, we continue to use 3 minutes as the estimated burden
for pharmacists to distribute Medication Guides to patients.
(Comment 2) One comment said that there are distributor costs to
comply with the Medication Guide requirements and FDA's estimate omits
Sec. 208.24(c), which provides that ``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, or the means to produce Medication Guides, to
each authorized dispenser to whom it ships a container of drug
product.'' The comment states that the December 21, 2011, notice of
proposed information collection (76 FR 79194) does not include an
estimate for the reporting requirements of Sec. 208.24(c) and that the
requirement should be included in FDA's assessment.
(Response) FDA has re-evaluated Sec. 208.24(c) with regards to
information collection burden on distributors and packers and
determined that Sec. 208.24(c) does not contain an additional
collection of information subject to the reporting requirements of the
PRA. A ``collection of information'' includes an Agency request or
requirement that members of the public submit reports, keep records, or
provide information to third parties or the public by or for an Agency.
Therefore, the manufacturer is responsible for providing information to
third parties (Sec. 208.24(a)), i.e., Medication Guides, and the
distributor or packer distributes the Medication Guides with the
shipment of drugs to the dispensers. Thus, Sec. 208.24(c) is not
subject to the reporting requirements of the PRA.
(Comment 3) One comment says that FDA should reassess the need to
provide Medication Guides with each prescription refill and states
there are situations where it is not necessary due to certain
circumstances. The comment states that Medication Guides should be a
tool to enhance the level of care to consumers, rather than a hindrance
to pharmacists in their ability to provide quality patient care.
(Response) FDA agrees and directs the comment to the guidance made
available to the public entitled ``Medication Guides--Distribution
Requirements and Inclusion in Risk Evaluation and Mitigation Strategies
(REMS).'' In this guidance, FDA articulates the circumstances under
which FDA intends to exercise enforcement discretion regarding the
requirement to provide Medication Guides in certain settings.

[[Page 24962]]

(Comment 4) One comment states that Medication Guides increasingly
become accessible online for download and print and the costs for
printing, including paper, toner, administrative, and software costs,
have shifted from the manufacturers to the pharmacies.
(Response) While Medication Guides are increasingly available
online for download and printing, the FDA does not agree that a
financial and acquisition burden has shifted to or been created for
dispensers. The comment mischaracterizes the cost to dispensers
associated with the distribution of Medication Guides. For purposes of
information collection requests under the PRA, capital costs are costs
for equipment, machinery, and construction that, if not for FDA's
request or requirement, the respondent would not incur. Capital costs
do not include costs to achieve regulatory compliance. The costs
presented by the comment are not capital costs because they are costs
associated with achieving regulatory compliance with requirements of
the FD&C Act, not costs associated specifically with equipment,
machinery, and construction needed to retain appropriate substantiating
evidence.
(Comment 5) One comment states that the length of Medication Guides
continues to be burdensome and hinders a pharmacist from utilizing a
potentially effective tool. The comment stresses the need for a
succinct, one-page document that can be easily integrated into current
pharmacy practice workflow.
(Response) FDA generally agrees with the comment and is currently
in the process of evaluating whether a one-page solution can be
implemented.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
208.20....................... 25 1 25 320 8,000
314.70(b)(3)(ii), 601.12(f).. 5 1 5 72 360
208.24(e).................... 59,000 5,000 295 million 3 minutes 14,750,000
208.26(a).................... 1 1 1 4 4
----------------------------------------------------------------------------------
Total.................... .............. .............. ................ ............... 14,758,364
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Dated: April 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10022 Filed 4-25-12; 8:45 am]
BILLING CODE 4160-01-P

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