Draft Guidance for Industry on Using Electronic Means to Distribute Certain Product Information; Availability, 57300-57301 [05-19731]
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Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
Dated: September 26, 2005.
Jacquelyn Y. White,
Director, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 05–19611 Filed 9–29–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
BILLING CODE 4120–01–P
[CMS–1307–CN]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
RIN 0938–ZA74
Medicare Program; Criteria and
Standards for Evaluating Intermediary,
Carrier, and Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Regional Carrier
Performance During Fiscal Year 2006;
Correction Notice
Food and Drug Administration
[Docket No. 2005D–0385]
Draft Guidance for Industry on Using
Electronic Means to Distribute Certain
Product Information; Availability
Food and Drug Administration,
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction notice.
AGENCY:
This document corrects
technical errors that appeared in the
general notice with comment period
published in the Federal Register on
September 23, 2005 entitled ‘‘Medicare
Program; Criteria and Standards for
Evaluating Intermediary, Carrier, and
Durable Medical Equipment,
Prosthetics, Orthotics and Supplies
(DMEPOS) Regional Carrier
Performance During Fiscal Year 2006.’’
EFFECTIVE DATE: This correction is
effective October 1, 2005.
FOR FURTHER INFORMATION CONTACT:
Richard Johnson, (410) 786–5633.
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Guidance for
Industry: Using Electronic Means to
Distribute Certain Product Information,’’
dated September 2005. The draft
guidance explains that persons can
distribute certain product information,
such as for recalls and drug safety, by
electronic means. We encourage the use
of electronic communications for
conveying all such important product
safety information. We are making clear
in this draft guidance that
manufacturers may disseminate
communications by e-mail or other
electronic methods.
DATES: Submit written or electronic
comments on the draft guidance by
November 29, 2005, to ensure their
adequate consideration in preparation of
the final guidance. General comments
on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Policy (HF–11), Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit phone requests to 301–827–
3360. Submit written comments on the
draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy (HF–
AGENCY:
HHS.
ACTION:
SUMMARY:
I. Background
In FR Doc. 05–18923 of September 23,
2005 (70 FR 55887), there were
technical errors that are identified and
corrected in the Correction of Errors
section below.
II. Correction of Errors
In FR Doc. 05–18923 of September 23,
2005 (70 FR 55887), make the following
corrections:
1. On page 55887, in the third
column, second paragraph, lines 2 and
3, the date ‘‘October 24, 2005’’ is
corrected to read ‘‘October 1, 2005.’’
2. On page 55888, in the first column,
first paragraph, lines 2 through 4, the
phrase ‘‘beginning on the first day of the
first month following publication of this
notice in the Federal Register’’ is
corrected to read, ‘‘October 31, 2005’.
3. On page 55888, in the first column,
fourth paragraph, lines 5 and 6, the Web
site address ‘‘or to https://
www.regulations.gov’’ is deleted.
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
PO 00000
Notice.
Frm 00053
Fmt 4703
Sfmt 4703
11), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–3360.
SUPPLEMENTARY INFORMATION:
I. Background
The timely dissemination of
communications about recalls of FDA
regulated products, important drug
safety information, and other important
product safety information is essential
for the protection of the public health.
We have encouraged manufacturers to
provide such information in a timely
manner to distributors, doctors, and
others. Over the years, we have worked
with manufacturers to promote the use
of electronic methods of communication
and encourage the use of innovative
technologies to disseminate safety
information, particularly those that
provide a public health benefit. We are
making clear in the draft guidance that
manufacturers may disseminate the
communications discussed in §§ 7.49
and 200.5 (21 CFR 7.49 and 200.5) by
e-mail or other electronic methods. The
draft guidance also applies to those
instances, not addressed in any
regulation, where we recommend that
manufacturers and distributors
voluntarily convey certain safety
information about their products to
members of the public.
The use of e-mail and other electronic
communications has dramatically
changed how we and the public convey
information. Electronic communications
have a number of advantages over
paper-based communications. They can
significantly shorten the time between
an event and the public’s knowledge of
the event. When the event involves
product safety, it is even more
important that accurate safety
information be transmitted rapidly. Email and other electronic
communications are generally
considered more efficient and more
timely than regular or traditional mail.
These communications involve
considerably less cost to the sender than
older, more traditional delivery services.
Verification of receipt or delivery is less
expensive and can be automatically
accomplished. Any necessary followup
(such as when receipt of the e-mail is
not acknowledged) also can be
accomplished electronically. If receipt is
never acknowledged, the sender can
resort to more traditional methods of
notification.
We interpret the provisions of §§ 7.49
and 200.5 to allow the use of e-mail and
other electronic communication
methods, such as fax or text messaging,
to accomplish any recall notification or
distribution of important safety
information. Section 7.49(b) provides
E:\FR\FM\30SEN1.SGM
30SEN1
Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
that ‘‘A recall communication can be
accomplished by telegrams, mailgrams,
or first class letters* * *.’’ Given the
use of the term ‘‘can,’’ we read the three
examples as being illustrative rather
than the sole means of accomplishing
recall communications. Electronic
notification is a viable alternative to
more traditional methods.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on using electronic means to distribute
certain product information. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/oc/guidance/
electronic.html or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: September 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–19731 Filed 9–28–05; 1:53 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set 552b(c)(4) and 552b(c)(6),
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
Title 5 U.S.C., as amended. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would be constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Sickle Cell Disease Clinical Research
Network.
Date: October 31–November 1, 2005.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: William J. Johnson, PhD,
Review Branch, Division of Extramural
Affairs, NIH/NHLBI, 6701 Rockledge Drive,
Bethesda, MD 20892–7924, 301–435–0317,
johnsonw@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 23, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19537 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could discuss
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
NHLBI Patient-Oriented K Applications.
Date: October 27–28, 2005.
Time: 9 a.m. to 4 p.m.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
57301
Agenda: To review and evaluate grant
applications.
Place: Sheraton Columbia Hotel, 10207
Wincopin Circle, Columbia, MD 21044.
Contact Person: Roy L White, PhD,
Scientific Review Administrator, Division of
Extramural Affairs, Review Branch, National
Heart, Lung, and Blood Institute, NIH, 6701
Rockledge Drive, Rm. 7202, Bethesda, MD
20892–7924, 301/435–0310,
whiterl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 23, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–19538 Filed 9–29–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public accordance with the provisions
set forth in sections 552(b)(c)(4) and
552b(c)(6), Title 5 U.S.C., as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group, Kidney, Urologic and
Hematologic Diseases D Subcommittee.
Date: October 18–19, 2005.
Open: October 18, 2005, 2 p.m. to 2:30 p.m.
Agenda: To review procedures and discuss
policy.
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 70, Number 189 (Friday, September 30, 2005)]
[Notices]
[Pages 57300-57301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19731]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0385]
Draft Guidance for Industry on Using Electronic Means to
Distribute Certain Product Information; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Guidance for
Industry: Using Electronic Means to Distribute Certain Product
Information,'' dated September 2005. The draft guidance explains that
persons can distribute certain product information, such as for recalls
and drug safety, by electronic means. We encourage the use of
electronic communications for conveying all such important product
safety information. We are making clear in this draft guidance that
manufacturers may disseminate communications by e-mail or other
electronic methods.
DATES: Submit written or electronic comments on the draft guidance by
November 29, 2005, to ensure their adequate consideration in
preparation of the final guidance. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of the Commissioner,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Submit phone requests to 301-827-3360. Submit
written comments on the draft guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
The timely dissemination of communications about recalls of FDA
regulated products, important drug safety information, and other
important product safety information is essential for the protection of
the public health. We have encouraged manufacturers to provide such
information in a timely manner to distributors, doctors, and others.
Over the years, we have worked with manufacturers to promote the use of
electronic methods of communication and encourage the use of innovative
technologies to disseminate safety information, particularly those that
provide a public health benefit. We are making clear in the draft
guidance that manufacturers may disseminate the communications
discussed in Sec. Sec. 7.49 and 200.5 (21 CFR 7.49 and 200.5) by e-
mail or other electronic methods. The draft guidance also applies to
those instances, not addressed in any regulation, where we recommend
that manufacturers and distributors voluntarily convey certain safety
information about their products to members of the public.
The use of e-mail and other electronic communications has
dramatically changed how we and the public convey information.
Electronic communications have a number of advantages over paper-based
communications. They can significantly shorten the time between an
event and the public's knowledge of the event. When the event involves
product safety, it is even more important that accurate safety
information be transmitted rapidly. E-mail and other electronic
communications are generally considered more efficient and more timely
than regular or traditional mail. These communications involve
considerably less cost to the sender than older, more traditional
delivery services. Verification of receipt or delivery is less
expensive and can be automatically accomplished. Any necessary followup
(such as when receipt of the e-mail is not acknowledged) also can be
accomplished electronically. If receipt is never acknowledged, the
sender can resort to more traditional methods of notification.
We interpret the provisions of Sec. Sec. 7.49 and 200.5 to allow
the use of e-mail and other electronic communication methods, such as
fax or text messaging, to accomplish any recall notification or
distribution of important safety information. Section 7.49(b) provides
[[Page 57301]]
that ``A recall communication can be accomplished by telegrams,
mailgrams, or first class letters* * *.'' Given the use of the term
``can,'' we read the three examples as being illustrative rather than
the sole means of accomplishing recall communications. Electronic
notification is a viable alternative to more traditional methods.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on using
electronic means to distribute certain product information. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The draft guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/oc/guidance/electronic.html or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: September 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19731 Filed 9-28-05; 1:53 pm]
BILLING CODE 4160-01-S
