80 FR 31601 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 106 (June 3, 2015)

Page Range		31601-31602
FR Document		2015-13473

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 106 (Wednesday, June 3, 2015)

[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Pages 31601-31602]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0168]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Disclosure Regarding Additional 
Risks in Direct-to-Consumer Prescription Drug Television Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Disclosure Regarding Additional 
Risks in Direct-to-Consumer Prescription Drug Television 
Advertisements'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

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: On January 15, 2015, the Agency submitted a 
proposed collection of information entitled, ``Disclosure Regarding 
Additional Risks in Direct-to-Consumer Prescription Drug Television 
Advertisements'' to OMB for review and clearance under 44 U.S.C. 3507. 
An Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control

[[Page 31602]]

number. OMB has now approved the information collection and has 
assigned OMB control number 0910-0785. The approval expires on May 31, 
2018. A copy of the supporting statement for this information 
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13473 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices 31601

Off-cycle Off-cycle
Technology credit—cars credit—trucks
(grams/mile) (grams/mile)

Active seat ventilation .................................................................................................................................. 1.0 1.3

Active aerodynamics .................................................................................................................................... Based on measured reduction in the
coefficient of drag

Active transmission warm-up ....................................................................................................................... 1.5 3.2
Active engine warm-up ................................................................................................................................ 1.5 3.2
Engine idle start-stop ................................................................................................................................... 2.5 4.4

C. General Motors Corporation high temperature, solar load, and including an opportunity for public
Using the alternative methodology humidity) and would not represent the comment.
approach discussed above, GM is real world benefits of the technology. Dated: May 27, 2015.
applying for credits for model years Therefore, GM has chosen to determine Byron Bunker,
2013 through 2015. These credits are for the appropriate off-cycle credits through Director, Compliance Division, Office of
a component of the air conditioning use of an alternative methodology. Transportation and Air Quality, Office of Air
system that results in air conditioning GM worked with Denso to perform and Radiation.
efficiency credits beyond those bench testing of EDVC with and without [FR Doc. 2015–13503 Filed 6–2–15; 8:45 am]
provided in the regulations. GM has the variable CS valve and quantified the BILLING CODE 6560–50–P
applied for off-cycle credits for the difference. Based on this analysis, GM
Denso SAS air conditioner compressor determined an off-cycle credit of 1.1
with variable crankcase suction valve grams of CO2 per mile were appropriate. DEPARTMENT OF HEALTH AND
technology. GM is requesting an off- GM substantiated these results by also HUMAN SERVICES
cycle GHG credit of 1.1 grams CO2 per performing vehicle tests using the AC17
mile for this technology. EPA currently test procedure. Food and Drug Administration
provides Mobile Air Conditioner (MAC) [Docket No. FDA–2014–N–0168]
GHG credits for reduced reheat using an III. EPA Decision Process
externally-controlled variable Agency Information Collection
displacement compressor (EVDC), EPA has reviewed the applications for
completeness and is now making the Activities; Announcement of Office of
which provides significant efficiency Management and Budget Approval;
improvements compared to the baseline applications available for public review
and comment as required by the Disclosure Regarding Additional Risks
fixed displacement compressors that in Direct-to-Consumer Prescription
were the norm at the time EPA created regulations. The off-cycle credit
applications submitted by FCA, Ford, Drug Television Advertisements
the GHG program. Under the 2012–2016
light-duty GHG program, the credit for and GM (with confidential business AGENCY: Food and Drug Administration,
using an EVDC is 1.7 grams of CO2 per information redacted) have been placed HHS.
mile. GM has a new EVDC design from in the public docket (see ADDRESSES ACTION: Notice.
Denso that further improves the section above) and on EPA’s Web site at
http://www.epa.gov/otaq/regs/ld-hwy/ SUMMARY: The Food and Drug
efficiency of the MAC compressor
greenhouse/ld-ghg.htm. EPA is Administration (FDA) is announcing
through the addition of a variable
providing a 30-day comment period on that a collection of information entitled,
crankcase suction valve (variable CS
the applications for off-cycle credits ‘‘Disclosure Regarding Additional Risks
valve). The Denso SAS compressor
described in this notice, as specified by in Direct-to-Consumer Prescription Drug
improves the internal valve system
the regulations. The manufacturers may Television Advertisements’’ has been
within the compressor to reduce the
submit a written rebuttal of comments approved by the Office of Management
internal refrigerant flow necessary
for EPA’s consideration, or may revise and Budget (OMB) under the Paperwork
throughout the range of displacements
an application in response to comments. Reduction Act of 1995.
that the compressor may use during its
After reviewing any public comments FOR FURTHER INFORMATION CONTACT: FDA
operating cycle. The variable CS valve
can provide a larger mass flow under and any rebuttal of comments submitted PRA Staff, Office of Operations, Food
maximum capacity and compressor by manufacturers, EPA will make a final and Drug Administration, 8455
start-up conditions, when high flow is decision regarding the credit requests. Colesville Rd., COLE–14526, Silver
ideal, then reduce to smaller openings EPA will make its decision available to Spring, MD 20993–0002, PRAStaff@
with reduced mass flow in mid or low the public by placing a decision fda.hhs.gov.
capacity conditions. The refrigerant document (or multiple decision SUPPLEMENTARY INFORMATION: On
exiting the crankcase is optimized documents) in the docket and on EPA’s January 15, 2015, the Agency submitted
across the range of operating conditions, Web site at http://www.epa.gov/otaq/ a proposed collection of information
creating benefits for the energy regs/ld-hwy/greenhouse/ld-ghg.htm. entitled, ‘‘Disclosure Regarding
consumption of the MAC system. While the broad methodologies used by Additional Risks in Direct-to-Consumer
tkelley on DSK3SPTVN1PROD with NOTICES

The ‘‘5-cycle’’ methodology would these manufacturers could potentially Prescription Drug Television
not adequately measure the real world be used for other vehicles and by other Advertisements’’ to OMB for review and
GHG reduction benefits of either the manufacturers, the vehicle specific data clearance under 44 U.S.C. 3507. An
EVDC or the variable CS valve. Only one needed to demonstrate the off-cycle Agency may not conduct or sponsor,
of the five tests is conducted with the emissions reductions would likely be and a person is not required to respond
air conditioner on and that test cycle different. In such cases, a new to, a collection of information unless it
represents worse case conditions (e.g., application would be required, displays a currently valid OMB control

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31602 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices

number. OMB has now approved the the Internet at http://www.reginfo.gov/ Silver Spring, MD 20993–0002, 240–
information collection and has assigned public/do/PRAMain. 402–7946, Connie.Wisner@fda.hhs.gov.
OMB control number 0910–0785. The Dated: May 29, 2015. SUPPLEMENTARY INFORMATION:
approval expires on May 31, 2018. A Leslie Kux,
copy of the supporting statement for this I. Introduction
Associate Commissioner for Policy.
information collection is available on FDA is requesting that public
[FR Doc. 2015–13472 Filed 6–2–15; 8:45 am]
the Internet at http://www.reginfo.gov/ stakeholders, including patient and
public/do/PRAMain. BILLING CODE 4164–01–P
consumer advocacy groups, health care
Dated: May 29, 2015. professionals, and scientific and
Leslie Kux, DEPARTMENT OF HEALTH AND academic experts, notify the Agency of
Associate Commissioner for Policy. HUMAN SERVICES their intent to participate in periodic
[FR Doc. 2015–13473 Filed 6–2–15; 8:45 am]
consultation meetings on the
Food and Drug Administration reauthorization of GDUFA. GDUFA
BILLING CODE 4164–01–P
authorizes FDA to collect fees from drug
[Docket No. FDA–2012–N–0882] companies that submit marketing
DEPARTMENT OF HEALTH AND applications for certain generic human
Generic Drug User Fees; Stakeholder drug applications, certain drug master
HUMAN SERVICES Meetings on Generic Drug User Fee files, and certain facilities. GDUFA
Food and Drug Administration Amendments of 2012 Reauthorization; requires that generic drug manufacturers
Request for Notification of Stakeholder pay user fees to finance critical and
[Docket No. FDA–2014–D–0313] Intention To Participate measurable generic drug program
Agency Information Collection AGENCY: Food and Drug Administration, enhancements. The statutory authority
Activities; Announcement of Office of HHS. for GDUFA expires at the end of
Management and Budget Approval; September 2017. Without new
ACTION: Notice; request for notification
Guidance for Industry, Researchers, legislation, FDA will no longer be able
of participation.
Patient Groups, and FDA Staff on to collect user fees for future fiscal years
Meetings With the Office of Orphan SUMMARY: The Food and Drug to fund the human generic drug review
Products Development Administration (FDA) is issuing this process. Section 744C(d) (21 U.S.C.
notice to request that public 379j–43(d)) of the FD&C Act requires
AGENCY: Food and Drug Administration, stakeholders, including patient and that FDA consult with a range of
HHS. consumer advocacy groups, health care stakeholders in developing
ACTION: Notice. professionals, and scientific and recommendations for the next GDUFA
academic experts, notify FDA of their program, including representatives from
SUMMARY: The Food and Drug patient and consumer groups, health
Administration (FDA) is announcing intent to participate in periodic
consultation meetings on the care professionals, and scientific and
that a collection of information entitled, academic experts. FDA will initiate this
‘‘Guidance for Industry, Researchers, reauthorization of the Generic Drug User
Fee Amendments of 2012 (GDUFA). The process on June 15, 2015, by holding a
Patient Groups, and FDA Staff on public meeting at which stakeholders
Meetings with the Office of Orphan statutory authority for GDUFA expires
at the end of September 2017. At that and other members of the public will be
Products Development’’ has been given an opportunity to present their
approved by the Office of Management time, new legislation will be required
for FDA to continue collecting user fees views on reauthorization (80 FR 22204).
and Budget (OMB) under the Paperwork The FD&C Act further requires that FDA
Reduction Act of 1995. for the generic drug program. The
Federal Food, Drug, and Cosmetic Act continue meeting with these
FOR FURTHER INFORMATION CONTACT: FDA stakeholders at least once every month
(the FD&C Act) requires that FDA
PRA Staff, Office of Operations, Food during negotiations with the regulated
consult with a range of stakeholders in
and Drug Administration, 8455 industry to continue discussions of
developing recommendations for the
Colesville Rd., COLE–14526, Silver stakeholder views on the
next GDUFA program. The FD&C Act
Spring, MD 20993–0002, PRAStaff@ reauthorization.
also requires that FDA hold continued
fda.hhs.gov. FDA is issuing this Federal Register
discussions with patient and consumer
SUPPLEMENTARY INFORMATION: On March advocacy groups at least monthly during notice to request that stakeholder
4, 2015, the Agency submitted a FDA’s negotiations with the regulated representatives from patient and
proposed collection of information industry. The purpose of this request for consumer groups, health care
entitled, ‘‘Guidance for Industry, notification is to ensure continuity and professional associations, as well as
Researchers, Patient Groups, and FDA progress in these monthly discussions scientific and academic experts notify
Staff on Meetings with the Office of by establishing consistent stakeholder FDA of their intent to participate in
Orphan Products Development’’ to OMB representation. periodic consultation meetings on
for review and clearance under 44 GDUFA reauthorization. FDA believes
U.S.C. 3507. An Agency may not DATES: Submit notification of intention that consistent stakeholder
conduct or sponsor, and a person is not to participate by August 14, 2015. representation at these meetings will be
required to respond to, a collection of ADDRESSES: Submit notification of important to ensuring progress in these
information unless it displays a intention to participate in monthly discussions. If you wish to participate in
stakeholder meetings by email to
tkelley on DSK3SPTVN1PROD with NOTICES

currently valid OMB control number. this part of the reauthorization process,
OMB has now approved the information GenericDrugPolicy@fda.hhs.gov. please designate one or more
collection and has assigned OMB FOR FURTHER INFORMATION CONTACT: representatives from your organization
control number 0910–0787. The Connie Wisner, Center for Drug who will commit to attending these
approval expires on May 31, 2018. A Evaluation and Research, Food and meetings and preparing for the
copy of the supporting statement for this Drug Administration, 10903 New discussions as needed. Stakeholders
information collection is available on Hampshire Ave., Bldg. 75, Rm. 1718, who identify themselves through this

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Document Created: 2015-12-15 15:08:33
Document Modified: 2015-12-15 15:08:33

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.
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 31601

80 FR 31601 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 106 (June 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration