[Federal Register Volume 75, Number 241 (Thursday, December 16, 2010)]
[Notices]
[Pages 78715-78716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31613]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0605]
Small Entity Compliance Guide: Current Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations
for Dietary Supplements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Current Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations
for Dietary
[[Page 78716]]
Supplements--Small Entity Compliance Guide.'' The small entity
compliance guide (SECG) is being issued for a final rule and an interim
final rule published in the Federal Register of June 25, 2007, and is
intended to set forth in plain language the requirements of that final
rule and interim final rule and to help small businesses understand the
regulations. In addition, the SECG includes several recommendations
made by FDA in that final rule so that the guidance in those
recommendations will be readily accessible to small businesses.
DATES: Submit either electronic or written comments on the SECG at any
time.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments on the SECG to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the SECG to the Division of Dietary Supplement Programs (HFS-
810), Office of Nutrition, Labeling, and Dietary Supplements, Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the SECG.
FOR FURTHER INFORMATION CONTACT: Bradford Williams, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1440.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 25, 2007 (72 FR 34752), FDA issued
a final rule establishing current good manufacturing practice (CGMP)
regulations for dietary supplements (21 CFR part 111) (the DS CGMP
final rule). The DS CGMP final rule requires persons who manufacture,
package, label, or hold a dietary supplement to establish and follow
current good manufacturing practice to ensure the quality of the
dietary supplement and to ensure that the dietary supplement is
packaged and labeled as specified in the master manufacturing record.
In that same issue of the Federal Register (72 FR 34959), FDA also
issued an interim final rule (the identity testing interim final rule)
that sets forth a procedure for requesting an exemption from a
requirement for the manufacturer to conduct at least one appropriate
test or examination to verify the identity of any dietary ingredient
that is a component of a dietary supplement. The final rule and the
identity testing interim final rule became effective August 24, 2007.
The compliance date of the DS CGMP final rule and the identity testing
interim final rule is June 25, 2008; except that for businesses
employing fewer than 500, but 20 or more full-time equivalent
employees, the compliance date is June 25, 2009; and except that for
businesses that employ fewer than 20 full-time equivalent employees,
the compliance date is June 25, 2010.
FDA examined the economic implications of the DS CGMP final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and
determined that the DS CGMP final rule would have a significant
economic impact on a substantial number of small entities. In
compliance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Public Law 104-121), FDA is making available
this SECG stating in plain language the requirements of the
regulations. We also examined the economic implications of the identity
testing interim final rule as required by the Regulatory Flexibility
Act and determined that the identity testing interim final rule would
not have a significant economic impact on a substantial number of small
entities. However, because the identity testing interim final rule
revises the DS CGMP final rule, the SECG includes the provisions of the
identity testing interim final rule.
FDA is issuing this SECG as level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115(c)(2)).\1\ The SECG
restates, in simplified format and language, FDA's requirements for
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements, including the
requirements for a Petition to Request an Exemption from 100 Percent
Identity Testing of Dietary Ingredients. In addition, the SECG includes
several recommendations made by FDA in the DS CGMP rule so that the
guidance in those recommendations will be readily accessible to small
businesses.
---------------------------------------------------------------------------
\1\ We note that the American Herbal Products Association
submitted a petition for reconsideration on July 25, 2007, under 21
CFR 10.33, requesting reconsideration of certain provisions of the
DS CGMP final rule. FDA is currently considering this petition and
the SECG does not represent a response to such petition.
---------------------------------------------------------------------------
The SECG represents FDA's current thinking on current good
manufacturing practice in manufacturing, packaging, labeling, or
holding operations for dietary supplements. 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.
We note, however, that the regulations that serve as the basis for this
guidance document establish requirements for all covered activities.
For this reason, we recommend that affected parties consult the
regulations at 21 CFR part 111 in addition to reading the SECG.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 111 have been approved under
0910-0606.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments on the SECG. It
is only necessary to send one set of comments. It is no longer
necessary to send two copies of mailed comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the SECG at http://www.fda.gov/FoodGuidances.html or http://www.regulations.gov.
Dated: December 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31613 Filed 12-15-10; 8:45 am]
BILLING CODE 4160-01-P