Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56487 

(b) Significance of calcium or calcium 

and vitamin D. Adequate calcium 

intake, or adequate calcium and vitamin 

D intake, is not the only recognized risk 

factor in the development of 

osteoporosis, which is a multifactorial 

bone disease. Maintenance of adequate 

calcium and vitamin D intakes 

throughout life is necessary to achieve 

optimal peak bone mass and to reduce 

the risk of osteoporosis in later life. 

However, vitamin D is most effective in 

this regard when calcium intake is 

adequate. Increasing intake of calcium 

has been shown to have beneficial 

effects on bone health independent of 

dietary vitamin D. 

(c) Requirements. (1) All requirements 

set forth in § 101.14 shall be met. 

(2) Specific requirements—(i) Nature 

of the claim. A health claim associating 

calcium or, when appropriate, calcium 

and vitamin D with a reduced risk of 

osteoporosis may be made on the label 

or labeling of a food described in 

paragraphs (c)(2)(ii) and (d)(1) of this 

section, provided that: 

(A) The claim makes clear the 

importance of adequate calcium intake, 

or when appropriate, adequate calcium 

and vitamin D intake, throughout life, in 

a healthful diet, are essential to reduce 

osteoporosis risk. The claim does not 

imply that adequate calcium intake, or 

when appropriate, adequate calcium 

and vitamin D intake, is the only 

recognized risk factor for the 

development of osteoporosis; 

(B) The claim does not attribute any 

degree of reduction in risk of 

osteoporosis to maintaining an adequate 

dietary calcium intake, or when 

appropriate, an adequate dietary 

calcium and vitamin D intake, 

throughout life. 

(ii) Nature of the food. (A) The food 

shall meet or exceed the requirements 

for a ‘‘high’’ level of calcium as defined 

in § 101.54(b); 

(B) The calcium content of the 

product shall be assimilable; 

(C) Dietary supplements shall meet 

the United States Pharmacopeia (USP) 

standards for disintegration and 

dissolution applicable to their 

component calcium salts, except that 

dietary supplements for which no USP 

standards exist shall exhibit appropriate 

assimilability under the conditions of 

use stated on the product label; 

(D) A food or total daily 

recommended supplement intake shall 

not contain more phosphorus than 

calcium on a weight per weight basis. 

(d) Optional information. (1) The 

claim may include the term ‘‘vitamin D’’ 

if the food meets or exceeds the 

requirements for a ‘‘high’’ level of 

vitamin D as defined in § 101.54(b); 

(2) The claim may include 

information from paragraphs (a) and (b) 

of this section. 

(3) The claim may make reference to 

physical activity. 

(4) The claim may include 

information on the number of people in 

the United States, including the number 

of people in certain subpopulations in 

the United States, who have 

osteoporosis or low bone density. The 

sources of this information must be 

identified, and it must be current 

information from the National Center for 

Health Statistics, the National Institutes 

of Health, or the National Osteoporosis 

Foundation. 

(5) The claim may state that the role 

of adequate calcium intake, or when 

appropriate, the role of adequate 

calcium and vitamin D intake, 

throughout life is linked to reduced risk 

of osteoporosis through the mechanism 

of optimizing peak bone mass during 

adolescence and early adulthood. The 

phrase ‘‘build and maintain good bone 

health’’ may be used to convey the 

concept of optimizing peak bone mass. 

The claim may also state that adequate 

intake of calcium, or when appropriate, 

adequate intake of calcium and vitamin 

D, is linked to reduced risk of 

osteoporosis through the mechanism of 

slowing the rate of bone loss for persons 

with a family history of the disease, 

post-menopausal women, and elderly 

men and women. 

(e) Model health claims. The 

following model health claims may be 

used in food labeling to describe the 

relationship between calcium and 

osteoporosis: 

Adequate calcium throughout life, as 

part of a well-balanced diet, may reduce 

the risk of osteoporosis. 

Adequate calcium as part of a healthful 

diet, along with physical activity, may 

reduce the risk of osteoporosis in later 

life. 

(f) Model additional health claims for 

calcium and vitamin D. The following 

model health claims may be used in 

food labeling to describe the 

relationship between calcium, vitamin 

D, and osteoporosis: 

Adequate calcium and vitamin D 

throughout life, as part of a wellbalanced diet, may reduce the risk of 

osteoporosis. 

Adequate calcium and vitamin D as part 

of a healthful diet, along with physical 

activity, may reduce the risk of 

osteoporosis in later life. 

Dated: September 11, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22730 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 314 

[Docket No. FDA–2008–N–0341] 

Applications for Food and Drug 

Administration Approval to Market a 

New Drug; Postmarketing Reports; 

Reporting Information About 

Authorized Generic Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to require that the holder of 

a new drug application (NDA) submit 

certain information regarding 

authorized generic drugs in an annual 

report. We are taking this action as part 

of our implementation of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA). FDAAA requires that 

FDA publish a list of all authorized 

generic drugs included in an annual 

report since 1999, and that the agency 

update the list quarterly. We are using 

direct final rulemaking for this action 

because the agency expects that there 

will be no significant adverse comment 

on the rule. In the proposed rule section 

of this issue of the Federal Register, we 

are concurrently proposing and 

soliciting comments on this rule. If 

significant adverse comments are 

received, we will withdraw this final 

rule and address the comments in a 

subsequent final rule. FDA will not 

provide additional opportunity for 

comment. 

DATES: This direct final rule is effective 

February 11, 2009. Submit written or 

electronic comments on or before 

December 15, 2008. If we receive no 

timely significant adverse comments, 

we will publish a notice in the Federal 

Register before January 12, 2009, 

confirming the effective date of the 

direct final rule. If we receive any 

timely significant adverse comments, 

we will publish a notice of significant 

adverse comment in the Federal 

Register withdrawing this direct final 

rule before February 11, 2009. 


jlentini on PROD1PC65 with RULES
56488 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N– 

0341, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michelle D.D. Bernstein, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, rm. 6223, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On September 27, 2007, the President 

signed into law FDAAA (Public Law 

110–85, 121 Stat. 823). Section 920 of 

FDAAA adds new section 505(t) to the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 355(t)) and requires 

that FDA take the following actions: 

• Publish on its Internet site a 

complete list of all authorized generic 

drugs included in an annual report 

submitted to the agency after January 1, 

1999, consisting of the drug trade name, 

the brand company manufacturer, and 

the date the authorized generic drug 

entered the market; 

• Update the list quarterly; and 

• Notify relevant Federal agencies, 

including the Centers for Medicare and 

Medicaid Services and the Federal 

Trade Commission, that the list has 

been published and will be updated 

quarterly. 

For purposes of publishing the list, 

section 505(t)(3) of the act defines the 

term ‘‘authorized generic drug’’ as a 

‘‘listed drug (as that term is used in 

[section 505(j) of the act]) that has been 

approved [under section 505(c) of the 

act] and is marketed, sold, or distributed 

directly or indirectly to retail class of 

trade under a different labeling, 

packaging (other than repackaging as the 

listed drug in blister packs, unit doses, 

or similar packaging for use in 

institutions), product code, labeler code, 

trade name, or trade mark than the 

listed drug.’’ 

Currently, there is no requirement 

that an NDA holder specifically report 

that it is marketing an ‘‘authorized 

generic drug.’’ NDA holders are required 

to include information about 

distribution or certain changes to 

manufacturing or labeling in annual 

reports, which may indicate that an 

authorized generic is being marketed. 

However, annual reports may not 

include all the information necessary for 

FDA to publish the list required by 

FDAAA. For example, sponsors rarely 

include the date the authorized generic 

entered the market. 

To allow FDA to accurately report a 

complete list of all authorized generic 

drugs included in annual reports and to 

update the list in a timely fashion, we 

are adding a requirement that annual 

reports specifically and clearly include 

the information we are required to 

report. In addition, we are requiring that 

the NDA holder report the date the 

authorized generic drug ceased being 

distributed to ensure that the list is as 

accurate and up-to-date as possible. The 

first annual report submitted after 

implementation of this regulation must 

provide information regarding any 

authorized generic drug that was 

marketed during the time period 

covered by an annual report submitted 

after January 1, 1999. 

There are currently 15 divisions in 

FDA that receive annual reports for over 

2,200 active NDAs. When information is 

included in an annual report about an 

authorized generic drug, we are 

requiring that a copy of that portion of 

the annual report be sent to a central 

office in the agency that will compile 

the list and update it quarterly. 

II. Direct Final Rulemaking 

We have determined that the subject 

of this rulemaking is suitable for a direct 

final rule. FDA expects this amendment 

to be noncontroversial, and the agency 

does not anticipate receiving any 

significant adverse comments on this 

rule. We have determined that 

publishing a direct final rule is the most 

appropriate method to meet the 

requirement, under section 505(t) of the 

act, that the agency publish a list of all 

authorized generic drugs. 

If we receive no significant adverse 

comment, we will publish a document 

in the Federal Register confirming the 

effective date of the direct final rule. A 

significant adverse comment is one that 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. A 

comment recommending a rule change 

in addition to this rule will not be 

considered a significant adverse 

comment unless the comment states 

why this rule would be ineffective 

without the additional change. If timely 

significant adverse comments are 

received, we will publish a notice of 

significant adverse comment in the 

Federal Register withdrawing this 

direct final rule within 30 days after the 

comment period ends. 

Elsewhere in this issue of the Federal 

Register, we are publishing a 

companion proposed rule, identical in 

substance to this direct final rule, that 

provides a procedural framework from 

which to proceed with standard noticeand-comment rulemaking in the event 

the direct final rule is withdrawn 

because of significant adverse comment. 

The comment period for the direct final 

rule runs concurrently with that of the 

companion proposed rule. Any 

comments received under the 

companion proposed rule will be 

treated as comments regarding the direct 

final rule. Likewise, significant adverse 

comments submitted to the direct final 

rule will be considered as comments to 

the companion proposed rule, and we 

will consider those comments in 

developing a final rule. We will not 

provide additional opportunity for 

comment on the companion proposed 

rule. 

If a significant adverse comment 

applies to part of this rule and that part 

may be severed from the remainder of 

the rule, we may adopt as final those 

parts of the rule that are not the subject 

of a significant adverse comment. A full 

description of our policy on direct final 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56489 

rule procedures may be found in a 

guidance document published in the 

Federal Register of November 21, 1997 

(62 FR 62466). 

III. Description of the Direct Final Rule 

We are defining the term ‘‘authorized 

generic drug’’ as a listed drug (as 

defined in § 314.3 (21 CFR 314.3)) that 

has been approved under section 505(c) 

of the act and is marketed, sold, or 

distributed directly or indirectly to 

retail class of trade with either labeling, 

packaging (other than repackaging as the 

listed drug in blister packs, unit doses, 

or similar packaging for use in 

institutions), product code, labeler code, 

trade name, or trade mark that differs 

from that of the listed drug. 

We are amending our regulations in 

§ 314.81 (21 CFR 314.81) to require that 

an NDA holder specifically report that 

it has marketed an authorized generic 

drug during the applicable time period. 

Section 314.81(b)(2) requires that an 

NDA holder submit an annual report 

within 60 days of the anniversary date 

of approval of an NDA for every NDA 

it holds. We are amending § 314.81 by 

redesignating paragraph (b)(2)(ii) 

regarding distribution data, as paragraph 

(b)(2)(ii)(a), and adding a new paragraph 

(b)(2)(ii)(b) regarding marketing of 

authorized generic drugs. This new 

paragraph states that, if an authorized 

generic drug was marketed under an 

NDA, or ceased to be marketed, during 

the reporting year, the annual report 

must list the date each authorized 

generic drug entered the market, the 

date each authorized generic drug 

ceased being distributed, and the 

corresponding trade or brand name. 

Each dosage form and/or strength is a 

different authorized generic drug and 

should be listed separately. The first 

annual report submitted after 

implementation of this regulation must 

include the required marketing 

information for any authorized generic 

drug that was marketed during the time 

period covered by an annual report 

submitted after January 1, 1999. 

If information is included in the 

annual report with respect to any 

authorized generic drug, a copy of the 

portion of the annual report with that 

information must be sent to the Food 

and Drug Administration, Center for 

Drug Evaluation and Research, Office of 

Pharmaceutical Science, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4183, 

Silver Spring, MD 20993–0002, and 

marked ‘‘Authorized Generic 

Submission.’’ This final rule assumes 

that the copy of the relevant portion of 

the annual report may currently be 

submitted in any number of formats 

(e.g., a paper copy, a PDF document on 

a computer disc). Current capabilities 

do not permit direct electronic 

submission through a Web-based 

system. However, FDA is committed to 

adapting its business practices to 

evolving technology, including using 

the significant advancements in Webbased, electronic systems. We anticipate 

that, in future rulemakings, Web-based 

submission of annual reports will 

eventually be required. In anticipation 

of that future change, this final rule 

provides that once an electronic 

submission format is adopted for annual 

reports, the submission to the agency of 

the information required under this 

regulation will also be required in that 

electronic format. We anticipate that 

when such a change is implemented, 

future guidance will address any 

technical questions related to such 

submissions. 

IV. Legal Authority 

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA), provides 

authority for FDA to issue this direct 

final rule. Section 505(t) of the act (21 

U.S.C. 355(t); FDAAA section 920) 

requires that FDA publish a complete 

list of all authorized generic drugs 

included in an annual report submitted 

to the agency after January 1, 1999, and 

to update that list quarterly. In addition, 

section 701(a) of the act (21 U.S.C. 

371(a)) provides general authority for 

FDA to issue regulations for the efficient 

enforcement of the act. This direct final 

rule would amend FDA’s existing 

regulations regarding annual reports in 

order to ensure that the information 

necessary for the agency to fulfill its 

obligation under section 505(t) is clearly 

reported. 

V. Environmental Impact 

We have carefully considered, under 

21 CFR part 25, the potential 

environmental effects of this action. We 

have concluded that this action will not 

have a significant impact on the human 

environment and that an environmental 

impact statement is not required. 

VI. Analysis of Impacts 

FDA has examined the impacts of the 

direct final rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this direct final rule is not 

a significant regulatory action as defined 

by the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this direct final rule 

imposes only minimal regulatory 

obligations, the agency certifies that the 

direct rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $130 

million, using the most current (2007) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this direct final rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

The only costs of this direct final rule 

are associated with the Paperwork 

Reduction Act burden, described in 

section VII of this document. If we 

assume an average hourly wage plus 

benefits of $56 for the reporting 

personnel, the annual cost is about 

$29,000 ($56 per hour x 520 hours). 

VII. The Paperwork Reduction Act of 

1995 

This direct final rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The title, 

description, and respondent description 

of the information collection provisions 

are shown with an estimate of the 

annual reporting and recordkeeping 

burden in Table 1 of this document. 

Included in the estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information. 

Title: Applications for FDA Approval 

to Market a New Drug; Postmarketing 

Reports; Reporting Information About 

Authorized Generic Drugs. 

Description: This rulemaking requires 

the holder of an NDA to notify the 


jlentini on PROD1PC65 with RULES
56490 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 

1 During fiscal year 2006, the Center for Drug 

Evaluation and Research received 2,569 annual 

reports under § 314.81(b)(2) from 374 sponsors. 

2See the Federal Register of January 4, 2008 (73 

FR 865). 

agency if an authorized generic drug is 

marketed by clearly including this 

information in annual reports in an 

easily accessible place and by sending a 

copy of the relevant portion of the 

annual reports to a central office. We are 

taking this action as part of our 

implementation of FDAAA, which 

requires that FDA publish a list of all 

authorized generic drugs included in an 

annual report after January 1, 1999, and 

that the agency update the list quarterly. 

We plan to publish this list on the 

Internet and to notify relevant Federal 

agencies that the list has been published 

and will be updated. 

Description of Respondents: Current 

holders of an NDA under which an 

authorized generic drug was marketed 

during the time period covered by an 

annual report submitted after January 1, 

1999. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 314.81(b)(2)(ii)(b) Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Authorized generic drug information 

in the first annual report submitted after the implementation of 

§ 314.81(b)(2)(ii)(b) 

60 6 .7 400 1 hour 400 

Authorized generic drug information 

submitted in each subsequent 

annual report 

60 6 .7 400 15 minutes 100 

The submission of a copy of that 

portion of each annual report 

containing authorized generic 

drug information 

60 6 .7 400 3 minutes 20 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

During the past several years, FDA 

has reviewed a small sample of annual 

reports it has received under 

§ 314.81(b)(2) to discern whether an 

authorized generic drug is being 

marketed by the NDA holder. Based on 

information learned from this review 

and based on the number of annual 

reports the agency currently receives 

under § 314.81(b)(2),1 we estimate that, 

after the implementation of 

§ 314.81(b)(2)(ii)(b), we will receive 

approximately 400 annual reports 

containing the information required 

under § 314.81(b)(2)(ii)(b) for authorized 

generic drugs that were marketed during 

the time period covered by an annual 

report submitted after January 1, 1999. 

Based on the number of sponsors that 

currently submit all annual reports, we 

estimate that approximately 60 sponsors 

will submit these 400 annual reports 

with authorized generics. As indicated 

in Table 1 of this document, we are 

estimating that the same number of 

annual reports will be submitted each 

subsequent year from the same number 

of sponsors containing the information 

required under § 314.81(b)(2)(ii)(b), and 

that the same number of copies of that 

portion of each annual report containing 

the authorized generic drug information 

will be submitted from the same number 

of sponsors. Concerning the hours per 

response, based on our estimate of 40 

hours to prepare each annual report 

currently submitted under 

§ 314.81(b)(2),2 we estimate that 

sponsors will need approximately 1 

hour to prepare the information 

required under § 314.81(b)(2)(ii)(b) for 

each authorized generic drug that was 

marketed during the time period 

covered by an annual report submitted 

after January 1, 1999; approximately 15 

minutes to prepare the information 

required under § 314.81(b)(2)(ii)(b) for 

each subsequent annual report; and 

approximately 3 minutes to submit to 

FDA a copy of that portion of each 

annual report containing the authorized 

generic drug information. 

VIII. Federalism 

FDA has analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13132. FDA 

has determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

IX. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

List of Subjects in 21 CFR Part 314 

Administrative practice and 

procedure, Confidential business 

information, Drugs, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 314 is 

amended as follows: 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 1. The authority citation for 21 CFR 

part 314 continues to read as follows: 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56491 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

■ 2. Section 314.3 is amended in 

paragraph (b) by adding the following 

definition for authorized generic drug in 

alphabetical order: 

§ 314.3 Definitions. 

* * * * * 

(b) * * * 

Authorized generic drug means a 

listed drug, as defined in this section, 

that has been approved under section 

505(c) of the act and is marketed, sold, 

or distributed directly or indirectly to 

retail class of trade with labeling, 

packaging (other than repackaging as the 

listed drug in blister packs, unit doses, 

or similar packaging for use in 

institutions), product code, labeler code, 

trade name, or trade mark that differs 

from that of the listed drug. 

* * * * * 

■ 3. Section 314.81 is amended by 

redesignating paragraph (b)(2)(ii) as 

paragraph (b)(2)(ii)(a) and by adding 

new paragraph (b)(2)(ii)(b) as follows: 

§ 314.81 Other postmarketing reports. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) * * * 

(b) Authorized generic drugs. If 

applicable, the date each authorized 

generic drug (as defined in § 314.3) 

entered the market, the date each 

authorized generic drug ceased being 

distributed, and the corresponding trade 

or brand name. Each dosage form and/ 

or strength is a different authorized 

generic drug and should be listed 

separately. The first annual report 

submitted on or after February 11, 2009, 

must include the information listed in 

this paragraph for any authorized 

generic drug that was marketed during 

the time period covered by an annual 

report submitted after January 1, 1999. 

If information is included in the annual 

report with respect to any authorized 

generic drug, a copy of that portion of 

the annual report must be sent to the 

Food and Drug Administration, Center 

for Drug Evaluation and Research, 

Office of Pharmaceutical Science, 10903 

New Hampshire Ave., Bldg. 51, rm. 

4183, Silver Spring, MD 20993–0002 

and marked ‘‘Authorized Generic 

Submission’’ or, if FDA has required 

that annual reports be submitted in an 

electronic format, the information 

required by this section must also be 

submitted in the electronic format. 

* * * * * 

Dated: September 16, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22833 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

OCCUPATIONAL SAFETY AND 

HEALTH REVIEW COMMISSION 

29 CFR Parts 2200 and 2203 

Rules of Procedure; Regulations 

Implementing the Government in the 

Sunshine Act; Corrections and 

Technical Amendments 

AGENCY: Occupational Safety and Health 

Review Commission. 

ACTION: Final rule; corrections and 

technical amendments. 

SUMMARY: The Occupational Safety and 

Health Review Commission (OSHRC) is 

making corrections and technical 

amendments to its rules and regulations, 

which include revisions to its address 

and regularly scheduled meeting time, 

as well as corrections of erroneous 

cross-references and a typographical 

error. 

DATES: Effective on September 29, 2008. 

FOR FURTHER INFORMATION CONTACT: Ron 

Bailey, Attorney-Advisor, Office of the 

General Counsel, by telephone at (202) 

606–5410, by e-mail at 

rbailey@oshrc.gov, or by mail at: 1120— 

20th Street, NW., Ninth Floor, 

Washington, DC 20036–3457. 

SUPPLEMENTARY INFORMATION: 

I. Background 

OSHRC is making several corrections 

and technical amendments to its Rules 

of Procedure found at 29 CFR part 2200, 

and its Regulations Implementing the 

Government in Sunshine Act found at 

29 CFR part 2203. 

As to 29 CFR part 2200, OSHRC is 

correcting a typographical error in 

§ 2200.63(b) by removing ‘‘zequesten¢’’ 

and adding in its place ‘‘requested.’’ 

Also, in §§ 2200.57(a) and 2200.96, 

OSHRC is amending the reference to its 

nine-digit ZIP code, which has been 

changed from 20036–3419 to 20036– 

3457. Finally, OSHRC is correcting 

cross-references that should have been 

amended when OSHRC revised its Rules 

of Procedure on July 3, 1997 (62 FR 

35961). In that revision, OSHRC 

reduced the period specified in 

§ 2200.90(b)(2) for transmitting a judge’s 

decision to the Executive Secretary from 

20 days to 10 days. This 20-day period 

was previously cross-referenced in 

§§ 2200.91(c) and 2200.209(g), but was 

inadvertently left unchanged. Therefore, 

§ 2200.91(c), which refers to ‘‘the 20 

days provided by § 2200.90(b),’’ is 

corrected to read ‘‘the 10 days provided 

by § 2200.90(b)’’; and § 2200.209(g), 

which refers to the ‘‘21 day period 

provided for in rule § 2200.90(b)(2),’’ is 

corrected to read the ‘‘11-day period 

provided for in rule § 2200.90(b)(2).’’ 

As to 29 CFR part 2203, OSHRC is 

amending the time of its regularlyscheduled meetings. Sections 2203.2 

(definition of ‘‘Regularly-scheduled 

meetings’’) and 2203.4(c) presently state 

that such meetings are held at 10 a.m. 

every Thursday, except for legal 

holidays. In both sections, this meeting 

time is being amended to ‘‘10:30 a.m.’’ 

every Thursday, except for legal 

holidays. Also, in §§ 2203.4(c) and 

2203.7(b), OSHRC is amending the 

reference to its nine-digit ZIP code from 

20036–3419 to 20036–3457. 

II. Statutory and Executive Order 

Reviews 

Waiver of Proposed Rulemaking: For 

good cause, OSHRC finds that prior 

notice and opportunity for comment on 

these changes are unnecessary pursuant 

to 5 U.S.C. 553(b)(3)(B), because the 

amendments and corrections to the 

affected sections are merely technical in 

nature and propose no substantive 

changes on which public comment 

could be solicited. 

Waiver of 30-Day Delayed Effective 

Date Requirement: OSHRC finds that 

good cause exists for the final rule to be 

exempt from the 30-day delayed 

effective date requirement of 5 U.S.C. 

553(d) because a delay in clarifying 

these rules would be contrary to the 

public interest. 

Executive Orders 12866 and 13132, 

and the Unfunded Mandates Reform 

Act of 1995: OSHRC is an independent 

regulatory agency, and, as such, is not 

subject to the requirements of E.O. 

12866, E.O. 13132, or the Unfunded 

Mandates Reform Act, 2 U.S.C. 1501 et 

seq. 

Regulatory Flexibility Act: OSHRC has 

determined that this rulemaking is 

exempt from the requirements of the 

Regulatory Flexibility Act, 5 U.S.C. 

604(a), because, as noted, a general 

notice of proposed rulemaking is not 

required under 5 U.S.C. 553(b). 

Paperwork Reduction Act of 1995: 

OSHRC has determined that the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., is not applicable here 

because this final rule contains no 

information collection requirements that 

require the approval of OMB. 

Congressional Notification: OSHRC 

has determined that the Congressional 

Review Act, 5 U.S.C. 801, is not 


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