80 FR 30688 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 103 (May 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 103 (May 29, 2015)
| Page Range | 30688-30689 | |
| FR Document | 2015-12976 |
[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)] [Notices] [Pages 30688-30689] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12976] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0902] Agency Information Collection Activities; Proposed Collection; 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 an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on regulations requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication. DATES: Submit either electronic or written comments on the collection of information by July 28, 2015. ADDRESSES: Submit electronic comments on the collection of information to: http://www.regulations.gov. Submit written comments on the collection of information to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506 (c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collections of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information listed below. With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumption used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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. 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. 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)...................... ------------------------------------------------------------------------------- [[Page 30689]] 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 21 CFR Section Number of disclosures Total annual Average burden Total hours respondents per respondent disclosures per 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 minutes). 22,184,000 Medication Guide--208.24(e). ---------------------------------------------------------------------------------- Total.................... .............. .............. .............. ................. 24,332,750 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-12976 Filed 5-28-15; 8:45 am] BILLING CODE 4164-01-P
![30688 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
Dated: May 22, 2015. FOR FURTHER INFORMATION CONTACT: FDA prescription human drug and biological
Leslie Kux, PRA Staff, Office of Operations, Food products used primarily on an
Associate Commissioner for Policy. and Drug Administration, 8455 outpatient basis that pose a serious and
[FR Doc. 2015–12957 Filed 5–28–15; 8:45 am] Colesville Rd., COLE–14526, Silver significant public health concern
BILLING CODE 4164–01–P Spring, MD 20993–0002, PRAStaff@ requiring distribution of FDA-approved
fda.hhs.gov. patient medication information. These
SUPPLEMENTARY INFORMATION: Under the Medication Guides inform patients
DEPARTMENT OF HEALTH AND PRA (44 U.S.C. 3501–3520), Federal about the most important information
HUMAN SERVICES Agencies must obtain approval from the they should know about these products
Office of Management and Budget in order to use them safely and
Food and Drug Administration (OMB) for each collection of effectively. Included is information such
[Docket No. FDA–2011–N–0902] information they conduct or sponsor. as the drug’s approved uses,
‘‘Collection of information’’ is defined contraindications, adverse drug
Agency Information Collection in 44 U.S.C. 3502(3) and 5 CFR reactions, and cautions for specific
Activities; Proposed Collection; 1320.3(c) and includes Agency requests populations, with a focus on why the
Comment Request; Prescription Drug or requirements that members of the
Product Labeling; Medication Guide particular product requires a Medication
public submit reports, keep records, or
Requirements Guide. These regulations are intended to
provide information to a third party.
improve the public health by providing
AGENCY: Food and Drug Administration, Section 3506 (c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal information necessary for patients to use
HHS. certain medication safely and
Agencies to provide a 60-day notice in
ACTION: Notice. effectively.
the Federal Register concerning each
SUMMARY: The Food and Drug proposed collection of information, The regulations contain the following
Administration (FDA) is announcing an including each proposed extension of an reporting requirements that are subject
opportunity for public comment on the existing collections of information, to the PRA:
proposed collection of certain before submitting the collection to OMB • 21 CFR 208.20—Applicants must
information by the Agency. Under the for approval. To comply with this
submit draft Medication Guides for FDA
Paperwork Reduction Act of 1995 (the requirement, FDA is publishing notice
of the proposed collection of approval according to the prescribed
PRA), Federal Agencies are required to content and format.
publish notice in the Federal Register information listed below.
concerning each proposed collection of With respect to the following • 21 CFR 314.70(b)(3)(ii) and 21 CFR
information, including each proposed collection of information, FDA invites 601.12(f)—Application holders must
extension of an existing collection of comments on: (1) Whether the proposed submit changes to Medication Guides to
information, and to allow 60 days for collection of information is necessary FDA for prior approval as supplements
public comment in response to the for the proper performance of FDA’s to their applications.
notice. This notice solicits comments on functions, including whether the
• 21 CFR 208.24(c)—Each distributor
regulations requiring the distribution of information will have practical utility;
or packer that receives Medication
patient labeling, called Medication (2) the accuracy of FDA’s estimate of the
burden of the proposed collection of Guides, or the means to produce
Guides, for certain products that pose a
information, including the validity of Medication Guides, from a manufacturer
serious and significant public health
the methodology and assumption used; under paragraph (b) of this section shall
concern requiring distribution of FDA-
approved patient medication. (3) ways to enhance the quality, utility, provide those Medication Guides to
and clarity of the information to be each authorized dispenser to whom it
DATES: Submit either electronic or
written comments on the collection of collected; and (4) ways to minimize the ships a container of drug product.
information by July 28, 2015. burden of the collection of information • 21 CFR 208.24(e)—Each authorized
ADDRESSES: Submit electronic on respondents, including through the dispenser of a prescription drug product
comments on the collection of use of automated collection techniques, for which a Medication Guide is
information to: http:// when appropriate, and other forms of required, when dispensing the product
www.regulations.gov. Submit written information technology. to a patient or to a patient’s agent, must
comments on the collection of Prescription Drug Product Labeling; provide a Medication Guide directly to
information to Division of Dockets Medication Guide Requirements each patient unless an exemption
Management (HFA–305), Food and Drug applies under 21 CFR 208.26.
Administration, 5630 Fishers Lane, Rm. OMB Control Number 0910–0393—
Extension • 21 CFR 208.26(a)—Requests may be
1061, Rockville, MD 20852. All
submitted for exemption or deferral
comments should be identified with the FDA regulations require the
from particular Medication Guide
docket number found in brackets in the distribution of patient labeling, called
heading of this document. Medication Guides, for certain content or format requirements.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
Lhorne on DSK2VPTVN1PROD with NOTICES
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
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![Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices 30689
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
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 dis- Average
Number of Total annual
21 CFR Section closures per burden per Total hours
respondents disclosures
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 min- 22,184,000
utes).
Total ................................................................................ ........................ ........................ ........................ ..................... 24,332,750
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 22, 2015. entitled, ‘‘Guidance for Industry on Guidelines for Federal Workplace Drug
Leslie Kux, Postmarketing Adverse Event Reporting Testing Programs (hair specimen).
Associate Commissioner for Policy. for Medical Products and Dietary DATES: Comment Close Date: To be
[FR Doc. 2015–12976 Filed 5–28–15; 8:45 am] Supplements During an Influenza assured consideration, comments must
BILLING CODE 4164–01–P
Pandemic’’ to OMB for review and be received at one of the addresses
clearance under 44 U.S.C. 3507. An provided below on or before June 29,
Agency may not conduct or sponsor, 2015.
DEPARTMENT OF HEALTH AND and a person is not required to respond
ADDRESSES: Because of staff and
HUMAN SERVICES to, a collection of information unless it
resource limitations, we cannot accept
displays a currently valid OMB control
Food and Drug Administration comments by facsimile (FAX)
number. OMB has now approved the
transmission. You may submit
information collection and has assigned
[Docket No. FDA–2014–N–1081] comments in one of four ways (please
OMB control number 0910–0701. The
choose only one of the ways listed):
Agency Information Collection approval expires on April 30, 2018. A
Electronically: You may submit
Activities; Announcement of Office of copy of the supporting statement for this
electronic comments to http://
Management and Budget Approval; information collection is available on
www.regulations.gov. Follow ‘‘Submit a
Guidance for Industry on the Internet at http://www.reginfo.gov/
comment’’ instructions.
Postmarketing Adverse Event public/do/PRAMain.
By regular mail: You may mail written
Reporting for Medical Products and Dated: May 22, 2015. comments to the following address only:
Dietary Supplements During an Leslie Kux, Substance Abuse and Mental Health
Influenza Pandemic Associate Commissioner for Policy. Services Administration, Attention:
AGENCY: Food and Drug Administration, [FR Doc. 2015–12977 Filed 5–28–15; 8:45 am] Division of Workplace Programs, 1
HHS. BILLING CODE 4164–01–P Choke Cherry Road, Room 7–1029,
Rockville, MD 20857. Please allow
ACTION: Notice. sufficient time for mailed comments to
SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND be received before the close of the
Administration (FDA) is announcing HUMAN SERVICES comment period.
that a collection of information entitled, By express or overnight mail: You
Substance Abuse and Mental Health may send written comments to the
‘‘Guidance for Industry on
Services Administration following address only: Substance
Postmarketing Adverse Event Reporting
for Medical Products and Dietary Abuse and Mental Health Services
Mandatory Guidelines for Federal Administration, Attention: Division of
Supplements During an Influenza Workplace Drug Testing Programs;
Pandemic’’ has been approved by the Workplace Programs, 1 Choke Cherry
Request for Information Regarding Road, Room 7–1029, Rockville, MD
Office of Management and Budget Specific Issues Related to the Use of
(OMB) under the Paperwork Reduction 20850.
the Hair Specimen for Drug Testing By hand or courier: Alternatively, you
Act of 1995.
AGENCY: Substance Abuse and Mental may deliver (by hand or courier) your
FOR FURTHER INFORMATION CONTACT: FDA
Health Services Administration written comments only to the following
PRA Staff, Office of Operations, Food address prior to the close of the
and Drug Administration, 8455 (SAMHSA), Department of Health and
Lhorne on DSK2VPTVN1PROD with NOTICES
Human Services (DHHS). comment period:
Colesville Rd., COLE–14526, Silver For delivery in Rockville, MD:
Spring, MD 20993–0002, PRAStaff@ ACTION: Request for Information.
Substance Abuse and Mental Health
fda.hhs.gov. SUMMARY: This document is a request for Services Administration, Attention:
SUPPLEMENTARY INFORMATION: On information regarding specific aspects of Division of Workplace Programs, 1
January 8, 2015, the Agency submitted the regulatory policies and standards Choke Cherry Road, Room 7–1029,
a proposed collection of information that may be applied to the Mandatory Rockville, MD 20850. To deliver your
VerDate Sep<11>2014 15:17 May 28, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1](https://thefederalregister.org/doc/80_FR_30791/page/2.svg)
Document Created: 2015-12-15 15:31:28
Document Modified: 2015-12-15 15:31:28
| 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 | Submit either electronic or written comments on the collection of information by July 28, 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 30688 |
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