Persius/hicric huggingface dataset:
CPG Sec. 525.225 - Whole Cassia or Whole 
Cinnamon, Ground Cinnamon - Adulteration by 
Insect and Rodent Filth; Mold; Mammalian 
Excreta 
REGULATORY ACTION GUIDANCE: 
1.  The following represents criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office within the Human and Animal Food Program*:  
Whole Cassia and Cinnamon Bark: 
a.  Insect Filth: 
The cassia or cinnamon bark averages 5% or more insect infested pieces by 
weight; 
or 
b.  Mold: 
The cassia or cinnamon bark averages 5% or more moldy pieces by weight; 
or 
c.  Mammalian Excreta: 
The cassia or cinnamon bark contains an average of 1 milligram or more of 
mammalian excreta per pound (mammalian excreta should be identified as to 
source when possible). 
2.  The following represents criteria for recommending legal action to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605): 
Ground Cinnamon:  
a.  Insect Filth: 
The cinnamon powder contains an average of 400 or more insect fragments per 50 
grams. 
or  b.  Rodent Filth: 
The cinnamon powder contains an average of 11 or more rodent hairs per 50 
grams. 
NOTE: Determination for all defects are made on a minimum of six (6) subsamples: 50-gram 
subsamples for the ground spice and 100-gram subsamples for the whole spice. 
REMARKS: 
Since the majority of spices are imported, determine that the lot in question has not been 
previously examined and released by FDA as an import. If the lot has been examined and 
released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of 
Enforcement (HFS-605) for seizure consideration in the usual manner. 
SPECIMEN CHARGE: 
Article (whole cassia/whole cinnamon/ground cinnamon) adulterated (when introduced into and 
while in interstate commerce) (while held for sale after shipment in interstate commerce), within 
meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by 
reason of presence therein of (insects), (insect webbing), (insect excreta), (insect fragments), 
(insect damaged whole cassia/whole cinnamon/whole cinnamon/ground cinnamon), and 
(mammalian excreta), (rodent hairs); and that it consists in part of a decomposed substance by 
reason of presence therein of (moldy, decomposed cassia/cinnamon). 
NOTE: Only use direct citation authority when prosecution is anticipated and evidence to 
support a prosecution is included with the adulteration charge. Evidence necessary to support a 
prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 2/1/86, 3/95, 5/05
CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy  
Draft Guidance for FDA Staff and Industry 
Document Release Date: February 18, 2005 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
Contains Nonbinding Recommendations 
DRAFT 
Preface 
Public Comment: 
Interested persons may submit written comments regarding this document to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to 
http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm. 
Additional Copies: 
A copy of the guidance may be downloaded to a personal computer with access to the Internet. The 
guidance may be accessed at http://www.fda.gov/ ICECI/ ComplianceManuals/ 
CompliancePolicyGuidanceManual/default.htm
CPG Sec. 515.700 Chocolate & Chocolate 
Liquor - Adulteration with Insect and Rodent 
Filth 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
1.  Insect Filth  
a.  The chocolate in six (6) 100 gram subsamples contains an average of 60 or more 
insect fragments per 100 grams. 
or 
b.  Any one subsample contains 90 or more insect fragments, even if the overall 
average of all the subsamples is less than 60. 
2.  Rodent Filth  
a.  The chocolate in six (6) 100 gram subsamples contains an average of more than 
1.0 rodent hair per 100 grams, regardless of the size of the hairs or hair fragments. 
or 
b.  Any one subsample contains more than 3 rodent hairs even if the overall average 
is less than 1.0 rodent hair. 
*NOTE: Insect and rodent filth analyses are conducted using method 965.38, Official Methods 
of Analysis, (2000) 17th Edition, AOAC, Gaithersburg, MD.* 
SPECIMEN CHARGE: 
Article adulterated (when introduced into and while in interstate commerce) (while held for sale 
after introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it 
consists in part of a filthy substance by reason of the presence therein of (insect fragments) 
(rodent hairs).  NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence necessary to support 
a prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 5/1/85 
Revised: 3/95, 8/96, 8/2000
CPG Sec. 230.140 Evaluation and Processing Post Donation Information Reports 
Issued: 7/9/99
Withdrawn: 7/16/2018
Guidance for Industry
Noise Claims in Hearing Aid
Labeling
Document issued on:  October 21, 1998
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Ear, Nose and Throat Devices Branch
Division of Reproductive, Abdominal, Ear,
Nose and Throat and Radiological Devices
Office of Device Evaluation Preface
Public Comment:
Comments and suggestions may be submitted at any time at any time for Agency
considerations to Eric Mann, CDRH, 9200 Corporate Blvd, HFZ-470,
Rockville, MD 20850 or by e-mail to eric.mann@fda.hhs.gov.  Comments may not be acted
upon by the Agency until the document is next revised or updated.  For questions
regarding the use or interpretation of this guidance, also contact Eric Mann at
(240) 276-4242 or by e-mail at eric.mann@fda.hhs.gov.
Additional Copies:
World Wide Web/CDRH home page at http://www.fda.gov/cdrh or CDRH Facts on
Demand at 1-800-899-0381 or 301-827-0111, specify number 2210 when prompted
for the document shelf number. Noise Claims In Hearing Aid Labeling
Manufacturers who make noise claims in their labeling for
hearing aids (e.g. improved speech understanding in noisy
environments) are no longer required to submit a 510(k)
premarket notification to obtain a substantially equivalent
decision in support of these claims.
Under the Food and Drug Administration Modernization Act
(FDAMA) of 1997, air conduction hearing aids are exempt from
premarket notification subject to limitations of exemptions
found in 21CFR 874.9.
The limitations of exemptions basically state that a major
change in the intended use of a hearing aid or a change in the
fundamental scientific technology would require a new 510(k)
submission.  Specifically, a change that only involves the
addition of a noise claim to the labeling, including promotion
and advertising materials, does not exceed the limitations of
exemptions and does not require a new 510(k).
Manufacturers should develop substantiating data, from
scientific and/or clinical studies, to support their claims.
This data should be kept and maintained at the manufacturers
facility.  The data should be made available for review at the
request of the FDA or made available during an FDA inspection.
Claims that are determined to be unsubstantiated may result in
the device being misbranded under Section 502 of the Federal
Food, Drug and Cosmetic Act.
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64093 64094 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64095 64096 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64097 64098 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64099 64100 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices
[FR Doc. 9731741 Filed 12297; 8:45 am]
BILLING CODE 416001C
Guidance for Industry
Q1C Stability Testing for New
Dosage Forms
ICH
November 1996 Guidance for Industry
Q1C Stability Testing for New
Dosage Forms
Additional copies are available from:
the Drug Information Branch, HFD-210,
Center for Drug Evaluation and Research (CDER),
5600 Fishers Lane, Rockville, MD  20857 (Tel) 301-827-4573
http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication,
Training, and Manufacturers Assistance (HFM-40)
Center for Biologics Evaluation and Research (CBER)
1401 Rockville Pike, Rockville, MD 20852-1448,
http://www.fda.gov/cber/guidelines.htm
(Fax) 888-CBERFAX or 301-827-3844
(Voice Information) 800-835-4709 or 301-827-1800
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
November  1996
ICH GUIDANCE FOR INDUSTRY1
Q1C Stability Testing for New Dosage Forms
I. GENERAL (1)
This document is an annex to the ICH Harmonized Tripartite Guideline on Stability Testing of
New Drug Substances and Products and addresses the recommendations on what should be
submitted regarding stability of new dosage forms by the owner of the original application, after
the original submission for new drug substances and products.
II. NEW DOSAGE FORM (2)
A new dosage form is defined as a drug product which is a different pharmaceutical product type,
but contains the same active substance as included in the existing drug product approved by the
pertinent regulatory authority.
Such pharmaceutical product types include products of different administration route (e.g., oral to
parenteral), new specific functionality/delivery systems (e.g., immediate release tablet to modified
release tablet) and different dosage forms of the same administration route (e.g., capsule to tablet,
solution to suspension).
Stability protocols for new dosage forms should follow the guidance in the parent stability
guideline in principle.  However, a reduced stability database at submission time (e.g., 6 months
accelerated and 6 months long-term data from ongoing studies) may be acceptable in certain
justified cases.
1This guidance was developed within the Expert Working Group (Quality) of the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been
subject to consultation by the regulatory parties, in accordance with the ICH process.  This document has been endorsed
by the ICH Steering Committee at Step 4 of the ICH process, November 1996.  At Step 4 of the process, the final draft is
recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.  This guidance
was published in the Federal Register on May 9, 1997 (62 FR 25634), and is applicable to drug and biological
products.  This guidance represents the Agencys current thinking on stability testing for new dosage forms.  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 statute, regulations, or both.
CPG Sec. 505.500 Macaroni and Noodle 
Products - Adulteration Involving Insect 
Fragments and Rodent Hairs  
BACKGROUND: 
The defect action levels established in this guide for macaroni and noodle products are based on 
an extrapolation of the defect action levels for soft wheat flour. These action levels are necessary 
as soft wheat flour is permitted to be incorporated into macaroni products, although most 
macaroni products are manufactured from durum flour and semolina which are excluded from 
the action levels established for wheat flour (See Sec. 578.450 for CPG 7104.06). A survey of 
macaroni and noodle products collected from the retail market provided data on the level of 
unavoidable insect and rodent filth in macaroni products and revealed that the majority of the 
samples contained filth levels significantly below the levels established in the guide. 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for recommending direct reference seizure *requests to the 
Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office within the Human and Animal Food Program*: 
1.  Insect Fragments: Actionable if the average insect fragments in six or more subsamples is 
greater than or equal to 225 per 225 grams 
or 
2.  Rodent Hairs: Actionable if the average rodent hairs in six or more subsamples is greater 
than or equal to 4.5 per 225 grams. 
*NOTE: Analyze by the method specified in AOAC XV Ed., 969.41.* 
SPECIMEN CHARGE: 
Article adulterated while held for sale after shipment in interstate commerce, within the meaning 
of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of 
presence therein of insect fragments and rodent hairs. 
NOTE: Only use direct citation authority when prosecution is anticipated and evidence to 
support a prosecution is included with the adulteration charge. Evidence necessary to support a 
prosecution is specified in existing regulatory procedures issuances.  *Material between asterisks is new or revised.* 
Issued: 1/4/82 
Revised: 8/96
CPG Sec. 527.200 Cheese & Cheese Products - 
Adulteration with Filth 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
The sample of cheese products was processed from reject quality milk tested during an 
establishment inspection, even though filth is not found in the sample. 
REMARKS: 
Reject quality milk is determined as follows: 
1.  The sediment factor for 12 mg. and 6 mg. sediment pads exceeds 10. (Add the sum of the 
percentages for sediment pads graded as 12 mg. and 6 mg.), 
or 
2.  The sediment factor for 12 mg. and 6 mg. sediment pads is 8 or more, determined as 
above, and the sediment factor for 12 mg., 6 mg., and 3 mg. sediment pads is 30 or more. 
(Add the sum of the percentages for sediment pads graded as 12 mg., 6 mg., and 3 mg.). 
Cans of milk with 2 or more flies are considered reject as are cans of milk from which 6 mg. and 
12 mg. sediment pads are obtained. 
The presence of manure fragments, insects, insect fragments or rodent hairs must be established 
by laboratory examination *(using the method described in AOAC XV Ed. 952.21)* of some of 
the 3 mg., 6 mg., and l2 mg. sediment pads to confirm the classification and show that reject 
quality milk was used. 
SPECIMEN CHARGE: 
Article (cheese) (cheese product) adulterated (when introduced into and while in interstate 
commerce) (while held for sale after introduction into interstate commerce), within the meaning 
of 21 U.S.C. 342(a)(4), in that it has been prepared under insanitary conditions whereby it may 
have become contaminated with filth. It was processed from reject quality (filthy) milk. 
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence necessary to support 
a prosecution is specified in existing regulatory procedures issuances.  *Material between asterisks is new or revised.* 
Issued: 11/1/81 
Revised: 3/95, 8/96
CPG Sec. 585.675 Popcorn - Adulteration with 
Rodent Filth and Field Corn 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement 
and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field 
Office within the Human and Animal Food Program*: 
If upon examination of 10/225 gm subs or 6/10 oz. consumer size packages one of the following 
conditions is met: 
1.  One or more rodent excreta pellets are found in one or more subs and one or more rodent 
hairs are found in a least two other subs. 
or 
2.  Examination shows two or more rodent hairs/lb., and rodent hair are found in 50% or 
more of the subs. 
or 
3.  Examination shows 20 or more gnawed kernels/lb., and rodent hair are found in 50% or 
more of the subs. 
or 
4.  Examination shows 5% or more by weight of field corn. 
SPECIMEN CHARGE: 
The article was adulterated when introduced into and while in interstate commerce, and is 
adulterated while held for sale after shipment in interstate commerce within the meaning of said 
Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence 
therein of rodent excreta pellets, rodent hair, and by reason of being rodent gnawed. 
If the adulteration is due to the presence of field corn, cite, "within the meaning of 21 U.S.C. 
342(b)(2) in that field corn has been substituted in part for popcorn." 
NOTES:  1.  If the evidence establishes that the article became adulterated after receipt in interstate 
commerce, then charge only that the article "is adulterated while held for sale after 
shipment in interstate commerce." 
2.  If the evidence does not establish where the article became adulterated and the violation 
is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then 
also charge only that the article "is adulterated while held for sale after shipment in 
interstate commerce." 
3.  Use direct reference citation authority only when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence to support a 
prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 7/1/83, 12/8/88, 8/96
CPG Sec. 525.425 Hops - Adulteration Involving 
Aphid Infestation 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement 
and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field 
Office within the Human and Animal Food Program*: 
The hops contain an average of 2500 or more aphids per 10 grams. 
REMARKS: 
Since the majority of spices are imported, determine that the lot in question has not been 
previously examined and released by FDA as an import. If the lot has been examined and 
released previously, submit all available facts to *CFSAN/Office of Field Programs/Division of 
Enforcement (HFS-605)* for seizure consideration in the usual manner.  
SPECIMEN CHARGE: 
Article adulterated while held for sale after shipment in interstate commerce, within meaning of 
21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of 
presence therein of insects. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 3/95
CPG Sec. 550.235 Cherry Jam - Adulteration 
with Mold 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
The jam has an average Howard mold count of 30% or more. 
SPECIMEN CHARGE: 
Article adulterated (when introduced into and while in interstate commerce) (while held for sale 
after introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it 
consists in part of a decomposed substance by reason of the presence therein of mold. 
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence necessary to support 
a prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 11/1/81, 3/95
CPG Sec. 550.250 Citrus Fruit Juices, 
Canned - Adulteration with Fly Filth and 
Mold 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office within the Human and Animal Food Program*: 
1.  Canned Citrus Juices (Single Strength)  
a.  Mold Count  
The canned juice has an average mold count of 10% or more 
2.  or 
a.  Fly Filth  
i.  The canned juice contains an average of 5 or more Drosophila and 
other fly eggs per 250 ml. 
or 
ii.  The canned juice contains an average of 1 or more Drosophila 
maggots per 250 ml. 
3.  Lemon and Lime Juice, et. al.  
The above tolerances can be applied to citrus juices and are concentrates when they are 
converted to a single strength basis. 
SPECIMEN CHARGE: 
Article adulterated (when introduced into and while in interstate commerce) (while held 
for sale after introduction into interstate commerce), within the meaning of 21 U.S.C. 
342(a)(3), in that it consists in part of a (decomposed) (filthy) substance by reason of the 
presence therein of (mold) (flies/fly eggs/maggots). 
NOTE: Only use direct reference citation authority when prosecution is anticipated and 
evidence to support a prosecution is included with the adulteration charge. Evidence  necessary to support a prosecution is specified in existing regulatory procedures 
issuances. 
*Material between asterisks is new or revised* 
Issued: 10/1/80 
Revised: 11/1/81, 3/95
CPG Sec. 550.260 Cranberry Sauce - 
Adulteration with Mold 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
The average Howard Mold Count for six or more subsamples exceeds 15% or if the Howard 
Mold Count for any one subsample exceeds 50%. 
SPECIMEN CHARGE: 
Article adulterated (when introduced and while in interstate commerce) (while held for sale after 
introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it 
consists in part of a decomposed substance by reason of the presence therein of moldy, 
decomposed cranberries. 
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence necessary to support 
a prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised* 
Issued: 10/1/80 
Revised: 11/1/81, 3/95