Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 68831

be small for purposes of RFA. 

Interpretive Ruling and Policy 

Statement (IRPS) 87–2 as amended by 

IRPS 03–2. The proposal clarifies and 

expands the lending rules to incorporate 

recent OGC opinions. The NCUA has 

determined and certifies that this 

proposed rule, if adopted, will not have 

a significant economic impact on a 

substantial number of small credit 

unions. Accordingly, the NCUA has 

determined that a Regulatory Flexibility 

Analysis is not required. 

Paperwork Reduction Act 

NCUA has determined that the 

proposed rule would not increase 

paperwork requirements under the 

Paperwork Reduction Act of 1995 and 

regulations of the Office of Management 

and Budget (OMB). NCUA currently has 

OMB clearance for § 701.21’s collection 

requirements (OMB No. 3133–0139). 

Executive Order 13132

Executive Order 13132 encourages 

independent regulatory agencies to 

consider the impact of their actions on 

State and local interests. In adherence to 

fundamental federalism principles, 

NCUA, an independent regulatory 

agency as defined in 44 U.S.C. 3502(5), 

voluntarily complies with the executive 

order. The proposed rule applies only to 

federal credit unions. NCUA has 

determined that the proposed 

amendments will not have a substantial 

direct effect on the States, on the 

connection between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. NCUA has 

determined that this proposed rule does 

not constitute a policy that has 

federalism implications for purposes of 

the executive order. 

The Treasury and General Government 

Appropriations Act, 1999—-Assessment 

of Federal Regulations and Policies on 

Families 

NCUA has determined that this 

proposed rule would not affect family 

well-being within the meaning of 

section 654 of the Treasury and General 

Government Appropriations Act, 1999, 

Pub. L. 105–277, 112 Stat. 2681 (1998). 

Agency Regulatory Goal 

NCUA’s goal is clear, understandable 

regulations that impose a minimal 

regulatory burden. We request your 

comments on whether the proposed rule 

is understandable and minimally 

intrusive if implemented as proposed.

List of Subjects in 12 CFR Part 701

Credit unions, Loans.

By the National Credit Union 

Administration Board on November 18, 2004. 

Mary Rupp, 

Secretary of the Board.

Accordingly, the National Credit 

Union Administration proposes to 

amend 12 CFR part 701 as follows:

PART 701—ORGANIZATION AND 

OPERATIONS OF FEDERAL CREDIT 

UNIONS 

1. The authority citation for part 701 

continues to read as follows:

Authority: 12 U.S.C. 1752(5), 1755, 1756, 

1757, 1759, 1761a, 1761b, 1766, 1767, 1782, 

1784, 1787, 1789.

2. Amend § 701.21 by revising 

paragraphs (e), (f) and (g)(1) to read as 

follows:

§ 701.21 Loans to members and lines of 

credit to members.

* * * * *

(e) Insured, guaranteed and advance 

commitment loans. A loan secured, in 

full or in part, by the insurance or 

guarantee of, or with an advance 

commitment to purchase the loan, in 

full or in part, by the Federal 

Government, a State Government or any 

agency of either, may be made for the 

maturity and under the terms and 

conditions, including rate of interest, 

specified in the law, regulations or 

program under which the insurance, 

guarantee or commitment is provided. 

(f) 20-year loans. (1) Notwithstanding 

the general 12-year maturity limit on 

loans to members, a federal credit union 

may make loans with maturities of up 

to 20 years in the case of: 

(i) A loan to finance the purchase of 

a mobile home if the mobile home will 

be used as the member-borrower’s 

residence and the loan is secured by a 

first lien on the mobile home, and the 

mobile home meets the requirements for 

the home mortgage interest deduction 

under the Internal Revenue Code; 

(ii) A second mortgage loan (or a 

nonpurchase money first mortgage loan 

in the case of a residence on which 

there is no existing first mortgage) if the 

loan is secured by a residential dwelling 

which is the residence of the memberborrower; and 

(iii) A loan to finance the repair, 

alteration, or improvement of a 

residential dwelling which is the 

residence of the member-borrower. 

(2) For purposes of this paragraph (f), 

mobile home may include a recreational 

vehicle, house trailer or boat. 

(g) Long-term mortgage loans—(1) 

Authority. A federal credit union may 

make residential real estate loans to 

members, including loans secured by 

manufactured homes permanently 

affixed to the land, with maturities of up 

to 40 years, or such longer period as 

may be permitted by the NCUA Board 

on a case-by-case basis, subject to the 

conditions of this paragraph (g)).

* * * * *

[FR Doc. 04–25996 Filed 11–24–04; 8:45 am] 

BILLING CODE 7535–01–P

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.

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 

68832 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

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.

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 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 

68834 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

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 § 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 § 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 § 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 § 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 § 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 

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 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 § 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.

Title Docket No. FR Publication Date and Cite 

Radioactive Drugs, Including Biological Products 75N–0069 July 25. 1975, 40 FR 31314

Conditions for Use of Methadone; Notice of Proposed Rulemaking 75N–0125 April 29, 1976, 41 FR 17922

Pasteurized Milk Ordinance and Interstate Milk Shippers 75N–0243 May 5, 1975, 40 FR 19513

Oral Contraceptive Drug Products; Physician and Patient Labeling 75N–0304 December 7, 1976, 41 FR 53633

Penicillin Streptomycin Powder; Penicillin-Dihydrostreptomycin Powder; Proposed Revocation of Certification Provision75N–0374 July 9, 1976, 41 FR 28313

Conditions for Use of Methadone; Physiologic Dependence, Staffing, and 

Urine Testing Requirements

76N–0098 April 29, 1976, 41 FR 17926

Sorbic Acid and Its Salts; Proposed Affirmation and Deletion of GRAS Status 77G–03791 March 10, 1978, 43 FR 9823

Butylated Hydroxytoluene; Use Restrictions 77N–00031 May 31, 1977, 42 FR 27603

Color Additives; Proposed Use of Abbreviations for Labeling Foods, Drugs, 

Cosmetics, and Medical Devices

77N–0009 and 78P–

0164

June 6, 1985, 50 FR 23815

Brown and Yellow Mustard and Their Derivatives; Proposed Affirmation of 

GRAS Status as Direct Human Food Ingredients

77N—00331 August 26, 1977, 42 FR 43092

Acrylonitrile Copolymers Intended for Use in Contact With Food; Proposed 

Rulemaking

77N—0078 March 11, 1977, 42 FR 13562

Gelatin; Affirmation of GRAS Status as a Direct and Indirect Human Food Ingredient77N–02321 November 11, 1977, 42 FR 58763 

and May 12, 1993, 58 FR 27959 

(tentative final rule)

New Animal Drugs for Use in Animal Feeds; Animal Feeds Containing Penicillin and Tetracycline77N–0318 January 20, 1978, 43 FR 3032

Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure77N–04241 June 23. 1978, 43 FR 27474

Label Designation of Ingredients in Cheese and Cheese Products 77P–0146 July 19, 1984, 49 FR 29242

Food Chemicals Codex Monographs; Opportunity for Public Comment on Revisions78N–0072 April 18, 1978, 43 FR 16413

68836 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

TABLE 1.—Continued

Title Docket No. FR Publication Date and Cite 

Cellulose Derivatives; Affirmation of GRAS Status 78N–01441 February 23, 1979, 44 FR 10751

Tocopherols and Derivatives; Proposed Affirmation of GRAS Status for Certain 

Tocopherols and Removal of Certain Others From GRAS Status as Direct 

Human Food Ingredients

78N–02131 October 27, 1978, 43 FR 50193

Chlortetracycline-Sulfamethazine Tablets; Proposed Rulemaking 78N–0247 September 22, 1978, 43 FR 43036

Phosphates; Proposed Affirmation of and Deletion From GRAS Status as Direct and Human Food Ingredients78N–0272 December 18, 1979, 44 FR 74845

Biotin; Proposed Affirmation of GRAS Status 78N–03081 January 14, 1983, 48 FR 1739

Lard and Lard Oil; Proposed Affirmation of GRAS Status as Indirect Human 

Food Ingredients

78N–03361 May 18, 1979, 44 FR 29102

Glycerin; Affirmation of GRAS Status as a Direct Human Food Ingredient 78N–03481 February 8, 1983, 48 FR 5758

Medical Devices; Classification of Sponges for Internal Use 78N–1074 November 28, 1978, 43 FR 55697

Medical Devices; Classification of Powered Myoelectric Biofeedback Equipment78N–1183 August 28, 1979, 44 FR 50464

Porcine Burn Dressing 78N–2670 January 19 1982, 47 FR 2828

Food Ingredient Labeling; Emulsifiers and Stabilizers; Exemptions 78P–0052 April 17, 1985, 50 FR 15177

Sodium Dithionite and Zinc Dithionite; Proposed Affirmation of GRAS Status 79N–00951 January 25, 1980, 45 FR 6117 and 

September 17, 1982, 47 FR 

41137 (tentative final rule)

Current Good Manufacturing Practice in Manufacture Processing, Packing, or 

Holding; Proposed Exemption From Active Ingredient Identity and Strength 

Testing for Homeopathic Drug Products

79P–0265 April 1, 1983, 48 FR 14003

Hydrochloric Acid; Proposed Affirmation of GRAS Status as a Direct Human 

Food Ingredient

80N–01481 April 26, 1984, 49 FR 17966

Cheeses and Related Cheese Products; General Standard of Identity for 

‘‘Certain Other Cheeses’’

80N–0373 April 23, 1984, 49 FR 17018

Caffeine; Deletion of GRAS Status, Proposed Declaration That No Prior Sanction Exists, and Use on an Interim Basis Pending Additional Study80N–04181 October 21, 1980, 45 FR 69817

Policy for Recognizing Carcinogenic Chemicals in Food and Color Additives; 

Advance Notice of Proposed Rulemaking

81N–0281 April 2, 1982, 47 FR 14464

Magnesium Gluconate, Potassium Gluconate, Sodium Gluconate, Zinc Gluconate, and Gluconic Acid: Proposed GRAS Status as Direct and Indirect 

Human Food Ingredients

81N–0382 October 29, 1982, 47 FR 49028

Protein Hydrolysates and Enzymatically Hydrolyzed Animal (Milk Casein) Protein; Proposed GRAS Status82N–00061 December 8, 1983, 48 FR 54990

Zinc Salts: Proposed Affirmation of GRAS Status 82N–01671 October 26, 1982, 47 FR 47441

Regenerated Collagen; Proposed GRAS Status as a Direct Human Food Ingredient82N–02191 April 26,1983, 48 FR 18833

Ascorbic Acid and Its Sodium and Calcium Salts, Erythorbic Acid and Its Sodium Salt, and Ascorbyl Palmitate; Proposed Affirmation of GRAS Status 

and Removal of Calcium Ascorbate From the List of GRAS Ingredients

82N–02461 January 14, 1983, 48 FR 1735

Caffeine in Nonalcoholic Carbonated Beverages 82N–0318 May 20, 1987, 52 FR 18923

Common or Usual Names for Nonstandardized Foods; Diluted Fruit or Vegetable Juice Beverages82N–0389 June 1, 1984, 49 FR 22831

Neurological Devices, Proposed Rule to Reclassify the Electroconvulsive Therapy Device Intended for Use in Treating Severe Depression82P–0316 September 5, 1990, 55 FR 36578

New Drug and Antibiotic Application Review; Proposed User Charge 84N–0101 August 6, 1985, 50 FR 31726

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 68837

TABLE 1.—Continued

Title Docket No. FR Publication Date and Cite 

Proposed Uses of Vinyl Chloride Polymers 84N–0334 February 3, 1986, 51 FR 4177

Unmodified Food Starches and Acid Modifled Starches—Proposed Affirmation 

of GRAS Status as Direct and Indirect Human Food Ingredients

84N–03411 April 1, 1985, 50 FR 12821

Use of Acrylonitrile Copolymers 85N–0145 March 8, 1990, 55 FR 8476

Hematology and Pathology Devices; Premarket Approval of the Automated 

Blood Cell Separator Intended for Routine Collection of Blood and Blood 

Components

85N–0241 February 19, 1988, 53 FR 5108

New Drugs for Human Use: Proposed Clarification of Requirements for Application Supplements86N–0077 June 4, 1986, 51 FR 20310

Quality Standards for Foods With No Identity Standards; Bottled Water 86N–0445 September 16, 1988, 53 FR 36063

Pineapple Juice; Proposal to Amend U.S. Standards of Identity and Quality 86P–0338 May 21, 1987, 52 FR 19169

New Animal Drug Regulations 88N–0058 December 17, 1991, 56 FR 65544

Current Good Manufacturing Practice for Blood and Blood Components; Proficiency Testing Requirements88N–0413 June 6, 1989, 54 FR 24296

Canned Pineapple; Proposal To Amend Standards of Identity and Quality 88P–0224 March 24, 1989, 54 FR 12237

Shellac and Shellac Wax; Proposed Affirmation of GRAS Status With Specific 

Limitations as Direct Human Food Ingredients

89N–0106 July 26, 1989, 54 FR 31055

Erythromycin Capsules; Proposed Amendment of Dissolution Standard of 

Erythromycin Capsules

89N–03781 October 26, 1989, 54 FR 43592

Yogurt Products; Frozen Yogurt, Frozen Lowfat Yogurt, and Frozen Nonfat Yogurt; Petitions To Establish Standards of Identity and To Amend the Existing 

Standards

89P–0208 and 89P–

0444

May 31, 1991, 56 FR 24760

Exemption From Preemption of State and Local Hearing Aid Requirements; 

Vermont

89P–0314 October 30, 1990, 55 FR 45615

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

90N–0361M January 6, 1993, 58 FR 2950

Use of Aseptic Processing and Terminal Sterilization in the Preparation of 

Sterile Pharmaceuticals for Human and Veterinary Use

91N–0074 October 11, 1991, 56 FR 51354

Cosmetic Products Containing Certain Hormone Ingredients; Notice of Proposed Rulemaking91N–0245 September 9, 1993, 58 FR 47611

Substances in Food-Contact Articles in the Household, Food Service Establishments, and Food Dispensing Equipment; Food Additive Status74–8424 April 12, 1974, 39 FR 13285

Drug Listing Compliance Verification Reports 92N–0291 September 2, 1993, 58 FR 46587

Food Labeling: Metric Labeling Requirements 92N–0406 May 21, 1993, 58 FR 29716

Food Labeling: Net Quantity of Contents; Compliance 92P–0441 March 4, 1997, 62 FR 9826

Cardiovascular Devices; Effective Date of Requirement for PMA of NonrollerType 

Cardiopulmonary Bypass Blood Pump

93M–0150 July 6, 1993, 58 FR 36290

Laser Products; Proposed Amendment to Performance Standards 93N–0044 March 24, 1999, 64 FR 14180

Quality Standards for Foods With No Identity Standards; Bottled Water 93N–0200 October 6, 1993, 58 FR 52042

Metric Labeling; Quantity of Contents Labeling Requirement for Foods, Human 

and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices

92N–0406 and 93N–

0226

December 21, 1993, 58 FR 67444

Lead in Food and Color Additives and GRAS Ingredients; Request for Data 93N–0348 February 4, 1994, 59 FR 5363

Substances Prohibited From Use in Animal Food or Feed; Specified Offal 

From Adult Sheep and Goats Prohibited in Ruminant Feed; Scrapie

93N–0467 August 29, 1994, 59 FR 44584

68838 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

TABLE 1.—Continued

Title Docket No. FR Publication Date and Cite 

Dental Devices; Effective Date of Requirement for Premarket Approval of 

Over-the-Counter (OTC) Denture Cushions or Pads and OTC Denture Repair Kits

95N–0034 July 11, 1995, 60 FR 35713

Food Labeling; Nutrient Content Claims and Health Claims; Special Requirements95N–0103 February 2, 1996, 61 FR 3885

Maltodextrin; Food Chemicals Codex Specifications 95N–0189 September 21, 1995, 60 FR 48939

Beverages: Bottled Water 95N–0203 November 13, 1995, 60 FR 57132

Dental Devices; Effective Date of Requirement for Premarket Approval of Partially Fabricated Denture Kits95N–0298 November 29, 1995, 60 FR 61232

Lowfat and Skim Milk Products, Lowfat and Nonfat Yogurt Products, Lowfat 

Cottage Cheese: Proposed Revocation of Standards of Identity; Food Labeling, Nutrient Content Claims for Fat, Fatty Acids and Cholesterol Content of 

Food

95P–0250 November 9, 1995, 60 FR 56541

Food Standards; Reinvention of Regulations Needing Revisions, Request for 

Comments on Certain Existing Regulations

96N–0149 June 12, 1996, 61 FR 29701

Reinvention of Certain Food Additive Regulations 96N–0177 June 12, 1996, 61 FR 29711

Food Labeling; Declaration of Free Glutamate In Food 96N–0244 September 12, 1996, 61 FR 48102

Regulation of Medical Foods 96N–0364 November 29, 1996, 61 FR 60661

Food Labeling: Nutrient Content Claims Pertaining to the Available Fat Content 

of Food

96N–0421 and 94P–

0453/CP1

December 20, 1996, 61 FR 67243

Food Labeling; Serving Sizes; Reference Amounts for Candies 96P–0023 and 96P–

0179

January 8, 1998, 63 FR 1078

1Denotes 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

DEPARTMENT OF THE TREASURY

Internal Revenue Service 

26 CFR Part 1

[REG–149519–03] 

RIN 1545–BC63

Section 707 Regarding Disguised 

Sales, Generally

AGENCY: Internal Revenue Service (IRS), 

Treasury.

ACTION: Notice of proposed rulemaking 

and notice of public hearing. 

SUMMARY: This document contains 

proposed regulations relating to the 

treatment of transactions between a 

partnership and its partners as disguised 

sales of partnership interests between 

the partners under section 707(a)(2)(B) 

of the Internal Revenue Code (Code). 

The proposed regulations affect 

partnerships and their partners, and are 

necessary to provide guidance needed to 

comply with the applicable tax law. 

This document also provides notice of 

a public hearing on these proposed 

regulations.

DATES: Written or electronic comments 

must be received by February 24, 2005. 

Requests to speak and outlines of topics 

to be discussed at the public hearing 

scheduled for March 8, 2005, at 10 a.m. 

must be received by February 24, 2005.

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–149519–03), room 

5203, Internal Revenue Service, PO Box 

7604, Ben Franklin Station, Washington, 

DC 20044. Submissions may be handdelivered Monday through Friday 

between the hours of 8 a.m. and 4 p.m. 

to CC:PA:LPD:PR (REG–149519–03), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC, or sent 

electronically, via the IRS internet site 

http://www.irs.gov/regs or via the 

Federal eRulemaking Portal site at

http://www.regulations.gov (indicate 

IRS and REG–149519–03). The public 

hearing will be held in the IRS 

Auditorium, Seventh Floor, Internal 

Revenue Building, 1111 Constitution 

Avenue, NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Concerning the proposed regulations, 

Deane M. Burke or Christopher L. 

Trump, (202) 622–3070; concerning 

submissions of comments, the hearing, 

or to be placed on the building access 

list to attend the hearing, Treena V. 

Garrett, (202) 622–7180 (not toll-free 

numbers).

SUPPLEMENTARY INFORMATION: 

Paperwork Reduction Act 

The collection of information 

contained in this notice of proposed 

rulemaking has been submitted to the 

Office of Management and Budget for 

review in accordance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3507(d)). Comments on the 

collection of information should be sent 

to the Office of Management and 

Budget, Attn: Desk Officer for the 

Department of the Treasury, Office of 

Information and Regulatory Affairs, 

Washington, DC 20503, with copies to 

the Internal Revenue Service, Attn: IRS 

Reports Clearance Officer, 

SE:W:CAR:MP:T:T:SP, Washington, DC 

20224. Comments on the collection of 

information should be received by