[Federal Register Volume 69, Number 227 (Friday, November 26, 2004)]
[Proposed Rules]
[Pages 68831-68838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter 1

[Docket No. 2002N-0434]


Withdrawal of Certain Proposed Rules and Other Proposed Actions

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of proposed rules.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of certain advance notice of proposed rulemakings (ANPRMs), 
proposed rules, and other proposed actions that published in the 
Federal Register more than 5 years ago. These proposals are no longer 
considered viable candidates for final action at this time. FDA is 
taking this action to reduce its regulatory backlog and focus its 
resources on current public health issues. The FDA's actions are part 
of an overall regulatory reform strategy initiated by Health and Human 
Services (HHS) Secretary Tommy G. Thompson.

DATES: The proposed rules are withdrawn as of November 26, 2004.

FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Regulations Policy 
and Management Staff (HF-26), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 8, 2001, Secretary Thompson announced his regulatory reform 
initiative designed to reduce regulatory burdens in health care and 
respond faster to the concerns of health care providers, State and 
local governments, and individual Americans who are affected by HHS 
rules. In December 2001, the Secretary announced the membership of his 
Regulatory Reform Committee designed to carry out his initiative. In 
November 2002, the Committee released its final report with over 255 
specific recommendations for simplifying, streamlining, and generally 
reducing the regulatory burden while

[[Page 68832]]

continuing to require accountability by those doing business with HHS 
and its agencies. Over 25 of the recommendations have been adopted, and 
the Secretary charged the Office of the Assistant Secretary for 
Planning and Evaluation to continue the efforts of the Regulatory 
Reform Committee. FDA's continuing efforts to finalize or withdraw 
regulations that have been proposed but not finalized are part of this 
overall initiative.
    In 1990, FDA began this process of conducting periodic, 
comprehensive reviews of its regulations process that included 
reviewing the backlog of ANPRMs, notices of proposed rulemaking, and 
other notices for which no final action or withdrawal notice had been 
issued. In the Federal Register of December 30, 1991 (56 FR 67440), FDA 
issued its first notice withdrawing 89 proposed rules that had 
published before December 31, 1985, but had never been finalized. Then 
again, in the Federal Register of January 20, 1994 (59 FR 3042), the 
agency withdrew an additional nine outstanding proposed rules.
    Once again, on April 22, 2003, FDA published a notice in the 
Federal Register (68 FR 19766) announcing its intent to withdraw 84 
proposed rules and other proposed actions that had published in the 
Federal Register more than 5 years ago, but that had never been 
finalized. Included in this list were 19 proposed rules that were 
originally proposed for withdrawal in 1991, but at that time the agency 
decided to defer its decision to withdraw or finalize them until a 
later date.
    The agency undertook this most recent review because it believes 
that the backlog of pending proposals dilutes its ability to 
concentrate on higher priority regulations that are mandated by statute 
or are necessary to address current public health issues. Because of 
the agency's limited resources and changing priorities, FDA has been 
unable to: (1) Consider, in a timely manner, the issues raised by the 
comments on these proposals and (2) complete the action on them. 
Additionally, because many of the proposals have become outdated in the 
time that has elapsed since their publication, the agency would need to 
obtain further comment on them before proceeding to final action. FDA 
has determined that the proposals identified in this document are lower 
in priority than those on the Unified Agenda and the Regulatory Plan. 
It is unlikely that the agency will have sufficient resources in the 
foreseeable future to further consider or prioritize these proposed 
rules. Although not required to do so by the Administrative Procedure 
Act or by regulations of the Office of the Federal Register, the agency 
believes the public interest is best served by withdrawing the 
proposals identified in this document. In some instances, the agency 
has already completed action on alternatives (e.g., the issuance of 
guidance or inclusion of provisions in related regulations) that have 
obviated the need to complete the proposed action. In addition, the 
agency notes that upon reviewing the comments and other records related 
to the rulemaking, the agency found that ``Amend Animal Care 
Regulations'' (Docket No. 89P-0320 (July 3, 1990, 55 FR 27476)) was the 
subject of a petition, and the agency assigned another docket number to 
that action. This action was finalized on July 15, 1991 (56 FR 32087), 
and therefore it is not necessary to be included in this withdrawal 
notice.
    The withdrawal of the proposals identified in this document does 
not preclude the agency from reinstituting proceedings to issue rules 
concerning the issues addressed in the proposals listed in table 1 of 
this document. Should FDA decide to undertake such a rulemaking 
sometime in the future, it will repropose the actions and provide new 
opportunities for comment.
    The agency notes that withdrawal of a proposal is not intended to 
affect whatever utility the preamble statements may currently have as 
indications of FDA's position on a matter at the time the proposal was 
published, and in some cases the preambles of these proposals may still 
reflect the current position of FDA on the matter addressed. Anyone 
unsure whether a statement in one of the preambles reflects the 
agency's current thinking should contact FDA.

II. Summary of and Responses to Comments

    FDA received a total of 37 letters, each containing 1 or more 
comments, in response to its notice of intent to withdraw certain 
proposed rules. The following is a discussion of the comments and the 
agency's response to those comments.

A. General Comments

    (Comment 1) One comment provided recommendations on FDA's overall 
withdrawal process and the way information in the notice of intent was 
presented to the public. The comment requested that the agency identify 
how it intended to handle each individual item included in the notice 
of intent including reasons for withdrawal and future actions. The 
comment also requested that the agency identify which preambles will 
continue to reflect the agency's current thinking even after the 
proposed rule has been withdrawn. Finally, the comment thought that FDA 
should have made all the proposed actions listed in the notice of 
intent available on FDA's Web site for easy access to all interested 
parties.
    (Response) The agency disagrees with these comments. The agency's 
decisions on the items proposed to be withdrawn were based on the 
general factors described in the notice of intent and whether the 
proposals fell within the listed factors. When the agency published the 
notice of intent, it did not have definite future plans for any of the 
items listed. The reason the agency stated that it may take future 
action was to emphasize that the withdrawals were based on resources 
and priorities. A withdrawal does not prevent the agency from taking 
action in the future on its own initiative or as a result of being 
prompted by the public. Also, a withdrawal of a proposed rule neither 
affirms nor rejects the views contained in the preamble. If someone 
wants a clarification of any agency policy or position, they should 
contact FDA.
    While not providing copies on its Web site, the agency provided the 
title, docket number, and Federal Register publication date and cite. 
The agency believes that, in most cases, this information was 
sufficient to allow readers to find the documents whether online or in 
a library. Also, the agency provided the name, address, and phone 
number of an FDA contact who was prepared to provide copies of each 
proposal, if requested. Therefore, none of these issues raised by this 
comment would have affected the ability of the public to comment on the 
items listed in the notice of intent.
    (Comment 2) One comment opposed the withdrawal of all the proposed 
generally recognized as safe (GRAS) actions listed in the notice of 
intent unless FDA could provide assurance that the agency would 
continue to permit the use of these food ingredients as detailed in the 
preamble statements.
    (Response) This withdrawal does not affect the regulatory status of 
the ingredients listed in these documents. Furthermore, the comment did 
not raise any issues not considered by FDA before publication of the 
notice of intent to withdraw. Therefore, FDA is withdrawing all the 
GRAS proposed rules listed in the notice of intent.
    (Comment 3) One comment recommended that the agency withdraw an 
ANPRM on hearing aids (58 FR 59695, November 10, 1993) that was not 
included in the notice of intent.

[[Page 68833]]

    (Response) While the agency agrees that this ANPRM is a good 
candidate for withdrawal, because it was not included in the original 
notice of intent, we will withdraw or take other action with respect to 
this proposal separately, in a future Federal Register notice.

B. Specific Comments

    The agency received specific comments on 17 of the documents listed 
in the notice of intent. These comments generally supported FDA's 
attempt at streamlining the regulations process, and in some cases, 
supported the agency's decision to withdraw a certain proposed rule. 
However, several of these comments opposed the agency's decision to 
withdraw a proposal. The specific comments received, and the agency's 
responses are as follows:
    1. Cosmetic Products Containing Certain Hormone Ingredients--Docket 
No. 91N-0245, September 9, 1993, 58 FR 47611
    FDA received 9 comments opposing the withdrawal of this proposed 
rule.
    (Comment 4) These comments argued that the withdrawal of this 
proposed rule would call into question the findings presented in the 
proposed rule and possibly change the marketing status of cosmetic 
products containing hormone ingredients.
    (Response) With regard to the first concern, as stated previously 
in this document, this withdrawal neither affirms nor rejects 
statements contained in the preamble. With regard to the second 
concern, the proposed rule was never finalized, and therefore 
withdrawal of the proposed rule does not affect the marketing status of 
these products. The agency intends to issue a new proposed rule 
regarding these products in the future.
    2. Caffeine in Nonalcoholic Carbonated Beverages--Docket No. 82N-
0318, May 20, 1987, 52 FR 18923
    3. Shellac and Shellac Wax; Proposed Affirmation of GRAS Status 
With Specific Limitations as Direct Human Food Ingredients--Docket No. 
89N-0106, July 26, 1989, 54 FR 31055
    4. Unmodified Food Starches and Acid-Modified Starches; Proposed 
Affirmation of GRAS Status as Direct and Indirect Food Ingredient--
Docket No. 84N-0341, April 1, 1985, 50 FR 12821
    5. Caffeine; Deletion of GRAS Status; Proposed Declaration That No 
Prior Sanction Exists and Use on an Interim Basis Pending Additional 
Study--Docket No. 80N-0418, October 21, 1980, 45 FR 69817
    6. Protein Hydrolysates and Enzymatically Hydrolyzed Animal (Milk 
Casein) Protein; Proposed GRAS Status--Docket No. 82N-0006, December 8, 
1983, 48 FR 54990
    7. Cellulose Derivatives; Affirmation of GRAS Status--Docket No. 
78N-0144, February 23, 1979, 44 FR 10751
    (Comment 5) FDA received five comments on these six GRAS proposed 
rules. The majority of the comments opposed the withdrawal of these 
proposals.
    (Response) None of the comments raised issues not considered by the 
agency before publication of the notice of intent to withdraw. 
Therefore, FDA is withdrawing all the GRAS proposed rules listed in the 
notice of intent. However, this withdrawal does not affect the 
regulatory status of the ingredients listed in these documents.
    8. Reclassification of Electroconvulsive Therapy--Docket No. 82P-
0316, September 5, 1990, 55 FR 36578
    (Comment 6) FDA received one comment supporting the withdrawal of 
this proposed rule. However, the comment was concerned that the 
information contained in this docket (i.e., reports of adverse 
reactions) would be disregarded when the proposed rule was withdrawn.
    (Response) The agency is withdrawing this proposed rule, and in the 
future, intends to start a new proceeding on this matter. The agency 
will retain the data and information contained in this docket and 
consider it at that time.
    9. Food Labeling; Declaration of Ingredients; Common or Usual Name 
Declaration for Protein Hydrolysates and Vegetable Broth in Canned 
Tuna; ``and/or'' Labeling for Soft Drinks--Docket No. 90N-361M, January 
6, 1993, 58 FR 2950
    (Comment 7) FDA received 15 comments supporting and one comment 
opposing the withdrawal of this proposed rule. The comment opposing the 
withdrawal of this proposed rule stated that the proposed rule 
memorialized the development of the agency's policy on ``and/or'' 
labeling for sweeteners in soft drinks and is the sole source of 
reference on these matters. The comment expressed concern that 
withdrawal may call into question current and future labeling practices 
of the soft drink industry regarding sweeteners in soft drinks.
    (Response) The agency disagrees with this comment's implication 
that the proposed rule announced a final FDA policy decision on ``and/
or'' labeling for sweeteners in soft drinks. By definition, a proposed 
rule only states the agency's tentative conclusions; with limited 
exceptions not applicable here, final decisions in the rulemaking 
context must be issued in a final rule after public notice and 
opportunity for comment (see 5 U.S.C. 553(b) to (c)). Further, the 
agency stated in the preamble to the proposed rule (58 FR 2950 at 2953) 
that its final decision on whether to revise its regulations to permit 
``and/or'' labeling for sweeteners in soft drinks would be based 
largely on whether comments in response to the proposed rule included 
data demonstrating that it is impracticable to produce the limited 
number of versions of a label that would be necessary if ``and/or'' 
labeling were not permitted. The agency received no such data and 
therefore did not have sufficient basis to proceed to a final rule 
allowing ``and/or'' labeling for soft drinks. Accordingly, this comment 
does not persuade the agency to reconsider the withdrawal of this 
proposed rule.
    Comments supporting the withdrawal of this proposal asked that the 
agency initiate enforcement action against soft drink manufacturers 
that use ``and/or'' labeling. The agency acknowledges that it has not 
pursued any enforcement action against soft drink manufacturers who are 
using ``and/or'' labeling because of the pending rulemaking. The agency 
is considering its position on the use of ``and/or'' labeling.
    10. Yogurt Products; Frozen Yogurt, Frozen Lowfat Yogurt; and 
Frozen Nonfat Yogurt; Petitions to Establish Standards of Identity and 
to Amend Existing Standards--Docket Nos. 89P-0208 and 89P-0444, May 31, 
1991, 56 FR 24760
    (Comment 8) The agency received one comment supporting the 
withdrawal of this proposed rule. The comment agreed that there is no 
need to complete this rulemaking since the agency issued an ANPRM (68 
FR 39873) in 2003 to address this issue.
    (Response) The agency agrees. Therefore, FDA is withdrawing this 
proposed rule.
    11. Canned Pineapple; Proposal to Amend Standards of Identity and 
Quality--Docket No. 88P-0224, March 24, 1989, 54 FR 12237
    FDA received two comments opposing the withdrawal of this proposed 
rule.
    (Comment 9) One comment requested that, if FDA withdraws the 
proposed rule, FDA allow marketing for canned pineapple as a 
nonstandardized product.
    (Response) FDA is denying this request because a product that 
purports to be or is represented as a food for which a standard of 
identity has been prescribed (e.g., canned pineapple) that does not 
comply with the provisions of that standard is misbranded under

[[Page 68834]]

section 403(g) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 343(g)). FDA notes, however, that regulations in Sec.  
130.17 (21 CFR 130.17) provide that manufacturers may market foods that 
deviate from established standards of identity if they receive 
temporary marketing permits from FDA.
    (Comment 10) The second comment stated that there are temporary 
marketing permits issued under this proposal that would not be valid if 
the proposal is withdrawn.
    (Response) The comment is incorrect. There are no active temporary 
marketing permits to market test a ``whole'' style of canned pineapple 
that are the basis of this proposed rule. There were two temporary 
market permits that were issued in 1988 to Dole Packaged Foods Co. (53 
FR 16471, May 9, 1988) and to Del Monte Corp. (53 FR 23602, June 22, 
1988), which expired after 15 months. The agency is withdrawing this 
proposed rule.
    12. Current Good Manufacturing Practices; Proposed Exemption From 
Active Ingredient Identity and Strength Testing for Homoeopathic Drug 
Products--Docket No. 79P-0265, April 1, 1983, 48 FR 14003
    (Comment 11) The agency received one comment opposing the 
withdrawal of this proposed rule which would have exempted homeopathic 
drugs from the current good manufacturing practice (CGMP) requirements 
that drug products be tested for identity and strength of each active 
ingredient prior to release for distribution. The comment expressed 
concerns about possible changes in our enforcement policy towards final 
release testing of homeopathic drugs.
    (Response) There may be instances where testing of a homeopathic 
product for identity and strength of the active ingredients prior to 
release for distribution would be appropriate and consistent with 
protection of the public health. For example, in instances where a 
product includes an active ingredient that at certain levels could be 
toxic or otherwise pose a public health concern, finished product 
testing may be appropriate because the testing could identify a 
significant manufacturing or labeling error. Since requiring this 
testing when necessary to protect the public health is consistent with 
FDA's mandate, we are withdrawing the proposed rule.
    13. Pineapple Juice; Proposal to Amend U.S. Standards of Identity 
and Quality--Docket No. 86P-0338, May 21, 1987, 52 FR 19169
    FDA received two comments opposing the withdrawal of this proposed 
rule.
    (Comment 12) One comment requested that if FDA withdraws the 
proposed rule, FDA allow marketing for pineapple juice as a 
nonstandardized product.
    (Response) FDA is denying this request because a product that 
purports to be or is represented as a food for which a standard of 
identity has been prescribed (e.g., pineapple juice) that does not 
comply with the provisions of that standard is misbranded under section 
403(g) of the act. FDA notes, however, that regulations in Sec.  130.17 
provide that manufacturers may market foods that deviate from 
established standards of identity if they receive temporary marketing 
permits from FDA.
    (Comment 13) The second comment stated that this proposed rule 
allowed the addition of pineapple juice from concentrate to pineapple 
juice to increase the brix level. Because the proposed rule addressed 
the use of pineapple juice from concentrate, the comment asks the 
agency either to complete this rulemaking or to publish a notice of 
policy that 21 CFR 102.33 (which applies to nonstandardized juices) 
would apply to pineapple juice.
    (Response) The comment is incorrect in stating that the proposed 
rule allowed the addition of pineapple juice from concentrate to 
increase the brix level of pineapple juice in Sec.  146.185 (21 CFR 
146.185). The proposed rule only proposed to amend the standard of 
identity to allow this change. This amendment would not be effective 
until the rule was finalized. Thus, currently, the standard of identity 
for pineapple juice in Sec.  146.185 does not permit the use of 
pineapple juice from concentrate to increase the brix level. A 
manufacturer who wishes to market pineapple juice with added pineapple 
juice from concentrate to increase the brix level may apply for a 
temporary marketing permit to do so. The agency is withdrawing this 
proposed rule.
    14. Regulation of Medical Foods--Docket No. 96N-0364, November 29, 
1996, 61 FR 60661
    (Comment 14) The agency received one comment opposing the 
withdrawal of this ANPRM. The comment stated that manufacturers are 
marketing therapeutic products directly to consumers without prior FDA 
approval of health claims or FDA review of the suitability of the 
ingredients for the intended population. The comment stated that 
current FDA policies in this area create a loophole for manufacturers 
to make unauthorized health claims and use ingredients that may not be 
GRAS.
    (Response) This comment does not persuade FDA that the ANPRM should 
not be withdrawn. Because of competing priorities that have tied up 
FDA's limited resources, the agency has been unable to consider, in a 
timely manner, the issues raised by comments on the ANPRM, and does not 
foresee having sufficient resources in the near term to do so. 
Therefore, the agency is withdrawing this ANPRM. However, FDA believes 
that the basic principles described in the ANPRM provide an appropriate 
framework for understanding the regulatory paradigm governing medical 
foods. Therefore, FDA advises that it will continue to refer to the 
basic principles described in the ANPRM and in FDA's Medical Foods 
Compliance Program (CP 7321.002) when evaluating medical foods. With 
regard to the specific points made in the comment regarding regulation 
of medical foods, the comment is correct that the act exempts medical 
foods from the nutrition labeling, health claim and nutrient content 
claim requirements that are applicable to most other foods. However, 
all statements on food labels (including medical foods) must be 
truthful and not misleading (see section 403(a)(1) of the act). FDA 
advises that medical foods with false or misleading labeling are 
subject to enforcement action. The agency also advises that withdrawal 
of this ANPRM does not change the requirement that all ingredients used 
in medical foods must be approved food additives, GRAS, or otherwise 
exempt from the food additive definition. Medical foods that do not 
comply with this requirement are subject to enforcement action.
    15. Food Labeling: Nutrient Content Claims Pertaining to the 
Available Fat Content of Food--Docket Nos. 96N-0421 and 94P-0453/CP1, 
December 20, 1996, 61 FR 67243
    (Comment 15) FDA received one comment opposing the withdrawal of 
this proposed rule. The comment states that misleading claims are being 
made by producers of products that contain nondigestible fat, including 
olestra, and that the total amount of fat in a product--regardless of 
whether it is digestible or nondigestible--should be declared to avoid 
consumer deception. The proposed rule responds in part to a citizen 
petition requesting use of digestibility coefficients in determining 
the quantity of fat declared in the label.
    (Response) Currently, FDA regulations require that nutrition 
labeling and claims reflect the total amount of fat, which is defined 
as total lipid fatty acids and expressed as triglycerides Sec.  
101.9(c)(2) (21 CFR 101.9(c)(2)). The only exceptions to this general 
requirement are provided in the following: (1) The voluntary nutrition

[[Page 68835]]

labeling final rule for raw fruit, vegetables, and fish (61 FR 42742, 
August 16, 1996) with respect to total fat in orange roughy fish and 
(2) the final rule for olestra (61 FR 3118, January 30, 1996) (61 FR 
67243 at 67246). In the final rule for olestra, FDA specified that 
olestra need not be considered as a source of fat or calories for 
purposes of nutrition labeling or nutrient content claims (21 CFR 
172.867(e)(5)).
    By withdrawing this proposed rule, FDA will not be authorizing the 
use of digestibility coefficients, so that the total amount of fat in a 
product must be declared on the label whether it is digestible or 
nondigestible as provided in Sec.  101.9(c)(2). However, withdrawing 
this proposed rule will have no effect on the nutrition labeling of 
products containing olestra or how the agency calculates the fat 
content of orange roughy for the purpose of voluntary nutrition 
labeling of that raw fish. Due to the agency's limited resources and 
other higher priority matters, the agency is withdrawing this proposed 
rule.
    16. Food Labeling; Nutrient Content Claims and Health Claims; 
Special Requirements--Docket No. 95N-0103, February 2, 1996, 61 FR 3885
    (Comment 16) The agency received one comment opposing the 
withdrawal of this proposed rule. The comment states that FDA access to 
records needed to evaluate the validity of nutrient content claims and 
health claims is essential to prevent consumer deception and ensure 
fair competition.
    (Response) FDA continues to believe that, for health and nutrient 
content claims that pose particular enforcement difficulties, it would 
be valuable for the agency to have access to information that the 
manufacturer relied on in determining that the food meets the 
requirements of the claims. As the agency stated in the proposed rule 
(61 FR 3385 at 3889), the claims that are likely to present enforcement 
difficulties are those based on new food technology or a new use of 
food technology, those based on the results of novel or non-
standardized testing procedures, and those which the agency cannot 
evaluate without information because the information is available only 
to the manufacturer. However, other higher priority matters require the 
agency's resources at this time, and therefore, the agency is 
withdrawing this proposed rule.
    17. Food Labeling; Declaration of Free Glutamate in Food--Docket 
No. 96N-0244, September 12, 1996, 61 FR 48102
    (Comment 17) FDA received two comments supporting the withdrawal of 
this ANPRM.
    (Response) Thus, the agency is withdrawing this ANPRM.
    For the reasons set forth previously, and under the act, the agency 
announces the withdrawal of the following documents, published in the 
Federal Register on the dates indicated in table 1:

                                Table 1.
------------------------------------------------------------------------
                                                        FR Publication
                Title                    Docket No.      Date and Cite
------------------------------------------------------------------------
Radioactive Drugs, Including           75N-0069       July 25. 1975, 40
 Biological Products                                   FR 31314
------------------------------------------------------------------------
Conditions for Use of Methadone;       75N-0125       April 29, 1976, 41
 Notice of Proposed Rulemaking                         FR 17922
------------------------------------------------------------------------
Pasteurized Milk Ordinance and         75N-0243       May 5, 1975, 40 FR
 Interstate Milk Shippers                              19513
------------------------------------------------------------------------
Oral Contraceptive Drug Products;      75N-0304       December 7, 1976,
 Physician and Patient Labeling                        41 FR 53633
------------------------------------------------------------------------
Penicillin Streptomycin Powder;        75N-0374       July 9, 1976, 41
 Penicillin-Dihydrostreptomycin                        FR 28313
 Powder; Proposed Revocation of
 Certification Provision
------------------------------------------------------------------------
Conditions for Use of Methadone;       76N-0098       April 29, 1976, 41
 Physiologic Dependence, Staffing,                     FR 17926
 and Urine Testing Requirements
------------------------------------------------------------------------
Sorbic Acid and Its Salts; Proposed    77G-0379\1\    March 10, 1978, 43
 Affirmation and Deletion of GRAS                      FR 9823
 Status
------------------------------------------------------------------------
Butylated Hydroxytoluene; Use          77N-0003\1\    May 31, 1977, 42
 Restrictions                                          FR 27603
------------------------------------------------------------------------
Color Additives; Proposed Use of       77N-0009 and   June 6, 1985, 50
 Abbreviations for Labeling Foods,      78P-0164       FR 23815
 Drugs, Cosmetics, and Medical
 Devices
------------------------------------------------------------------------
Brown and Yellow Mustard and Their     77N--0033\1\   August 26, 1977,
 Derivatives; Proposed Affirmation of                  42 FR 43092
 GRAS Status as Direct Human Food
 Ingredients
------------------------------------------------------------------------
Acrylonitrile Copolymers Intended for  77N--0078      March 11, 1977, 42
 Use in Contact With Food; Proposed                    FR 13562
 Rulemaking
------------------------------------------------------------------------
Gelatin; Affirmation of GRAS Status    77N-0232\1\    November 11, 1977,
 as a Direct and Indirect Human Food                   42 FR 58763 and
 Ingredient                                            May 12, 1993, 58
                                                       FR 27959
                                                       (tentative final
                                                       rule)
------------------------------------------------------------------------
New Animal Drugs for Use in Animal     77N-0318       January 20, 1978,
 Feeds; Animal Feeds Containing                        43 FR 3032
 Penicillin and Tetracycline
------------------------------------------------------------------------
Ethylene Oxide, Ethylene               77N-0424\1\    June 23. 1978, 43
 Chlorohydrin, and Ethylene Glycol;                    FR 27474
 Proposed Maximum Residue Limits and
 Maximum Levels of Exposure
------------------------------------------------------------------------
Label Designation of Ingredients in    77P-0146       July 19, 1984, 49
 Cheese and Cheese Products                            FR 29242
------------------------------------------------------------------------
Food Chemicals Codex Monographs;       78N-0072       April 18, 1978, 43
 Opportunity for Public Comment on                     FR 16413
 Revisions
------------------------------------------------------------------------

[[Page 68836]]

 
Cellulose Derivatives; Affirmation of  78N-0144\1\    February 23, 1979,
 GRAS Status                                           44 FR 10751
------------------------------------------------------------------------
Tocopherols and Derivatives; Proposed  78N-0213\1\    October 27, 1978,
 Affirmation of GRAS Status for                        43 FR 50193
 Certain Tocopherols and Removal of
 Certain Others From GRAS Status as
 Direct Human Food Ingredients
------------------------------------------------------------------------
Chlortetracycline-Sulfamethazine       78N-0247       September 22,
 Tablets; Proposed Rulemaking                          1978, 43 FR 43036
------------------------------------------------------------------------
Phosphates; Proposed Affirmation of    78N-0272       December 18, 1979,
 and Deletion From GRAS Status as                      44 FR 74845
 Direct and Human Food Ingredients
------------------------------------------------------------------------
Biotin; Proposed Affirmation of GRAS   78N-0308\1\    January 14, 1983,
 Status                                                48 FR 1739
------------------------------------------------------------------------
Lard and Lard Oil; Proposed            78N-0336\1\    May 18, 1979, 44
 Affirmation of GRAS Status as                         FR 29102
 Indirect Human Food Ingredients
------------------------------------------------------------------------
Glycerin; Affirmation of GRAS Status   78N-0348\1\    February 8, 1983,
 as a Direct Human Food Ingredient                     48 FR 5758
------------------------------------------------------------------------
Medical Devices; Classification of     78N-1074       November 28, 1978,
 Sponges for Internal Use                              43 FR 55697
------------------------------------------------------------------------
Medical Devices; Classification of     78N-1183       August 28, 1979,
 Powered Myoelectric Biofeedback                       44 FR 50464
 Equipment
------------------------------------------------------------------------
Porcine Burn Dressing                  78N-2670       January 19 1982,
                                                       47 FR 2828
------------------------------------------------------------------------
Food Ingredient Labeling; Emulsifiers  78P-0052       April 17, 1985, 50
 and Stabilizers; Exemptions                           FR 15177
------------------------------------------------------------------------
Sodium Dithionite and Zinc             79N-0095\1\    January 25, 1980,
 Dithionite; Proposed Affirmation of                   45 FR 6117 and
 GRAS Status                                           September 17,
                                                       1982, 47 FR 41137
                                                       (tentative final
                                                       rule)
------------------------------------------------------------------------
Current Good Manufacturing Practice    79P-0265       April 1, 1983, 48
 in Manufacture Processing, Packing,                   FR 14003
 or Holding; Proposed Exemption From
 Active Ingredient Identity and
 Strength Testing for Homeopathic
 Drug Products
------------------------------------------------------------------------
Hydrochloric Acid; Proposed            80N-0148\1\    April 26, 1984, 49
 Affirmation of GRAS Status as a                       FR 17966
 Direct Human Food Ingredient
------------------------------------------------------------------------
Cheeses and Related Cheese Products;   80N-0373       April 23, 1984, 49
 General Standard of Identity for                      FR 17018
 ``Certain Other Cheeses''
------------------------------------------------------------------------
Caffeine; Deletion of GRAS Status,     80N-0418\1\    October 21, 1980,
 Proposed Declaration That No Prior                    45 FR 69817
 Sanction Exists, and Use on an
 Interim Basis Pending Additional
 Study
------------------------------------------------------------------------
Policy for Recognizing Carcinogenic    81N-0281       April 2, 1982, 47
 Chemicals in Food and Color                           FR 14464
 Additives; Advance Notice of
 Proposed Rulemaking
------------------------------------------------------------------------
Magnesium Gluconate, Potassium         81N-0382       October 29, 1982,
 Gluconate, Sodium Gluconate, Zinc                     47 FR 49028
 Gluconate, and Gluconic Acid:
 Proposed GRAS Status as Direct and
 Indirect Human Food Ingredients
------------------------------------------------------------------------
Protein Hydrolysates and               82N-0006\1\    December 8, 1983,
 Enzymatically Hydrolyzed Animal                       48 FR 54990
 (Milk Casein) Protein; Proposed GRAS
 Status
------------------------------------------------------------------------
Zinc Salts: Proposed Affirmation of    82N-0167\1\    October 26, 1982,
 GRAS Status                                           47 FR 47441
------------------------------------------------------------------------
Regenerated Collagen; Proposed GRAS    82N-0219\1\    April 26,1983, 48
 Status as a Direct Human Food                         FR 18833
 Ingredient
------------------------------------------------------------------------
Ascorbic Acid and Its Sodium and       82N-0246\1\    January 14, 1983,
 Calcium Salts, Erythorbic Acid and                    48 FR 1735
 Its Sodium Salt, and Ascorbyl
 Palmitate; Proposed Affirmation of
 GRAS Status and Removal of Calcium
 Ascorbate From the List of GRAS
 Ingredients
------------------------------------------------------------------------
Caffeine in Nonalcoholic Carbonated    82N-0318       May 20, 1987, 52
 Beverages                                             FR 18923
------------------------------------------------------------------------
Common or Usual Names for              82N-0389       June 1, 1984, 49
 Nonstandardized Foods; Diluted Fruit                  FR 22831
 or Vegetable Juice Beverages
------------------------------------------------------------------------
Neurological Devices, Proposed Rule    82P-0316       September 5, 1990,
 to Reclassify the Electroconvulsive                   55 FR 36578
 Therapy Device Intended for Use in
 Treating Severe Depression
------------------------------------------------------------------------
New Drug and Antibiotic Application    84N-0101       August 6, 1985, 50
 Review; Proposed User Charge                          FR 31726
------------------------------------------------------------------------

[[Page 68837]]

 
Proposed Uses of Vinyl Chloride        84N-0334       February 3, 1986,
 Polymers                                              51 FR 4177
------------------------------------------------------------------------
Unmodified Food Starches and Acid      84N-0341\1\    April 1, 1985, 50
 Modifled Starches--Proposed                           FR 12821
 Affirmation of GRAS Status as Direct
 and Indirect Human Food Ingredients
------------------------------------------------------------------------
Use of Acrylonitrile Copolymers        85N-0145       March 8, 1990, 55
                                                       FR 8476
------------------------------------------------------------------------
Hematology and Pathology Devices;      85N-0241       February 19, 1988,
 Premarket Approval of the Automated                   53 FR 5108
 Blood Cell Separator Intended for
 Routine Collection of Blood and
 Blood Components
------------------------------------------------------------------------
New Drugs for Human Use: Proposed      86N-0077       June 4, 1986, 51
 Clarification of Requirements for                     FR 20310
 Application Supplements
------------------------------------------------------------------------
Quality Standards for Foods With No    86N-0445       September 16,
 Identity Standards; Bottled Water                     1988, 53 FR 36063
------------------------------------------------------------------------
Pineapple Juice; Proposal to Amend     86P-0338       May 21, 1987, 52
 U.S. Standards of Identity and                        FR 19169
 Quality
------------------------------------------------------------------------
New Animal Drug Regulations            88N-0058       December 17, 1991,
                                                       56 FR 65544
------------------------------------------------------------------------
Current Good Manufacturing Practice    88N-0413       June 6, 1989, 54
 for Blood and Blood Components;                       FR 24296
 Proficiency Testing Requirements
------------------------------------------------------------------------
Canned Pineapple; Proposal To Amend    88P-0224       March 24, 1989, 54
 Standards of Identity and Quality                     FR 12237
------------------------------------------------------------------------
Shellac and Shellac Wax; Proposed      89N-0106       July 26, 1989, 54
 Affirmation of GRAS Status With                       FR 31055
 Specific Limitations as Direct Human
 Food Ingredients
------------------------------------------------------------------------
Erythromycin Capsules; Proposed        89N-0378\1\    October 26, 1989,
 Amendment of Dissolution Standard of                  54 FR 43592
 Erythromycin Capsules
------------------------------------------------------------------------
Yogurt Products; Frozen Yogurt,        89P-0208 and   May 31, 1991, 56
 Frozen Lowfat Yogurt, and Frozen       89P-0444       FR 24760
 Nonfat Yogurt; Petitions To
 Establish Standards of Identity and
 To Amend the Existing Standards
------------------------------------------------------------------------
Exemption From Preemption of State     89P-0314       October 30, 1990,
 and Local Hearing Aid Requirements;                   55 FR 45615
 Vermont
------------------------------------------------------------------------
Food Labeling; Declaration of          90N-0361M      January 6, 1993,
 Ingredients, Common or Usual Name                     58 FR 2950
 Declaration for Protein Hydrolysates
 and Vegetable Broth in Canned Tuna;
 ``and/or'' Labeling for Soft Drinks
------------------------------------------------------------------------
Use of Aseptic Processing and          91N-0074       October 11, 1991,
 Terminal Sterilization in the                         56 FR 51354
 Preparation of Sterile
 Pharmaceuticals for Human and
 Veterinary Use
------------------------------------------------------------------------
Cosmetic Products Containing Certain   91N-0245       September 9, 1993,
 Hormone Ingredients; Notice of                        58 FR 47611
 Proposed Rulemaking
------------------------------------------------------------------------
Substances in Food-Contact Articles    74-8424        April 12, 1974, 39
 in the Household, Food Service                        FR 13285
 Establishments, and Food Dispensing
 Equipment; Food Additive Status
------------------------------------------------------------------------
Drug Listing Compliance Verification   92N-0291       September 2, 1993,
 Reports                                               58 FR 46587
------------------------------------------------------------------------
Food Labeling: Metric Labeling         92N-0406       May 21, 1993, 58
 Requirements                                          FR 29716
------------------------------------------------------------------------
Food Labeling: Net Quantity of         92P-0441       March 4, 1997, 62
 Contents; Compliance                                  FR 9826
------------------------------------------------------------------------
Cardiovascular Devices; Effective      93M-0150       July 6, 1993, 58
 Date of Requirement for PMA of                        FR 36290
 Nonroller-Type
Cardiopulmonary Bypass Blood Pump
------------------------------------------------------------------------
Laser Products; Proposed Amendment to  93N-0044       March 24, 1999, 64
 Performance Standards                                 FR 14180
------------------------------------------------------------------------
Quality Standards for Foods With No    93N-0200       October 6, 1993,
 Identity Standards; Bottled Water                     58 FR 52042
------------------------------------------------------------------------
Metric Labeling; Quantity of Contents  92N-0406 and   December 21, 1993,
 Labeling Requirement for Foods,        93N-0226       58 FR 67444
 Human and Animal Drugs, Animal
 Foods, Cosmetics, and Medical
 Devices
------------------------------------------------------------------------
Lead in Food and Color Additives and   93N-0348       February 4, 1994,
 GRAS Ingredients; Request for Data                    59 FR 5363
------------------------------------------------------------------------
Substances Prohibited From Use in      93N-0467       August 29, 1994,
 Animal Food or Feed; Specified Offal                  59 FR 44584
 From Adult Sheep and Goats
 Prohibited in Ruminant Feed; Scrapie
------------------------------------------------------------------------

[[Page 68838]]

 
Dental Devices; Effective Date of      95N-0034       July 11, 1995, 60
 Requirement for Premarket Approval                    FR 35713
 of Over-the-Counter (OTC) Denture
 Cushions or Pads and OTC Denture
 Repair Kits
------------------------------------------------------------------------
Food Labeling; Nutrient Content        95N-0103       February 2, 1996,
 Claims and Health Claims; Special                     61 FR 3885
 Requirements
------------------------------------------------------------------------
Maltodextrin; Food Chemicals Codex     95N-0189       September 21,
 Specifications                                        1995, 60 FR 48939
------------------------------------------------------------------------
Beverages: Bottled Water               95N-0203       November 13, 1995,
                                                       60 FR 57132
------------------------------------------------------------------------
Dental Devices; Effective Date of      95N-0298       November 29, 1995,
 Requirement for Premarket Approval                    60 FR 61232
 of Partially Fabricated Denture Kits
------------------------------------------------------------------------
Lowfat and Skim Milk Products, Lowfat  95P-0250       November 9, 1995,
 and Nonfat Yogurt Products, Lowfat                    60 FR 56541
 Cottage Cheese: Proposed Revocation
 of Standards of Identity; Food
 Labeling, Nutrient Content Claims
 for Fat, Fatty Acids and Cholesterol
 Content of Food
------------------------------------------------------------------------
Food Standards; Reinvention of         96N-0149       June 12, 1996, 61
 Regulations Needing Revisions,                        FR 29701
 Request for Comments on Certain
 Existing Regulations
------------------------------------------------------------------------
Reinvention of Certain Food Additive   96N-0177       June 12, 1996, 61
 Regulations                                           FR 29711
------------------------------------------------------------------------
Food Labeling; Declaration of Free     96N-0244       September 12,
 Glutamate In Food                                     1996, 61 FR 48102
------------------------------------------------------------------------
Regulation of Medical Foods            96N-0364       November 29, 1996,
                                                       61 FR 60661
------------------------------------------------------------------------
Food Labeling: Nutrient Content        96N-0421 and   December 20, 1996,
 Claims Pertaining to the Available     94P-0453/CP1   61 FR 67243
 Fat Content of Food
------------------------------------------------------------------------
Food Labeling; Serving Sizes;          96P-0023 and   January 8, 1998,
 Reference Amounts for Candies          96P-0179       63 FR 1078
------------------------------------------------------------------------
\1\Denotes documents that were included in the December 1991 withdrawal
  notice, but were not withdrawn at that time.


    Dated: August 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-26234 Filed 11-24-04; 8:45 am]
BILLING CODE 4160-01-S