[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]


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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.

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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.
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    \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.
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    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