Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50033 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0466] 

Over the Counter Cough and Cold 

Medications for Pediatric Use; Notice 

of Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing to obtain input regarding 

over-the-counter (OTC) cough and cold 

drugs marketed for pediatric use. Many 

of these nonprescription cough and cold 

drug products are marketed under the 

OTC Drug Review, which established a 

monograph describing the conditions 

under which certain OTC ingredients 

are considered to be generally 

recognized as safe and effective. 

Recently, safety and efficacy concerns 

have been raised regarding the pediatric 

dosing and use of certain active 

ingredients in OTC cough and cold drug 

products. FDA is developing a proposed 

rule to revise the pediatric labeling 

contained in the Final Monograph for 

Cough, Cold, Allergy, Bronchodilator, 

and Antiasthmatic Drug Products for 

Over-the-Counter Human Use. At this 

public hearing, FDA is interested in 

obtaining public comment about certain 

scientific, regulatory, and product use 

issues as it proceeds with the 

rulemaking and reviews new drug 

applications (NDAs) for these 

ingredients. 

Dates and Times: The public hearing 

will be held on October 2, 2008, from 

8 a.m. to 5 p.m. 

Location: The public hearing will be 

held at the Sheraton Washington North 

Hotel, 4095 Powder Mill Rd., Beltsville, 

MD 20705. 

ADDRESSES: Submit written registration 

and written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic registration to http:// 

www.regulations.gov. 

Submit electronic comments to http:// 

www.regulations.gov. All comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the hearing. 

For Registration to Attend and/or 

Participate in the Hearing: 

Seating at the hearing is limited. People 

interested in attending should submit 

written or electronic registration to the 

Division of Docket Management (see 

ADDRESSES) by close of business on 

September 15, 2008. Registration is free 

and will be on a first-come, first-served 

basis. Written or electronic comments 

will be accepted until December 2, 

2008. 

If you wish to make an oral 

presentation at the hearing, you must 

state your intention on your registration 

submission (see ADDRESSES). To speak, 

submit your name, title, business 

affiliation, address, telephone and fax 

numbers, and e-mail address. FDA has 

included questions for comment in 

section II of this document. You should 

also identify by number each question 

you wish to address in your 

presentation. FDA will do its best to 

accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. 

If you need special accommodations 

because of a disability, please inform 

Faith Dugan, (see For Information on the 

Hearing Contact). 

For Information on the Hearing 

Contact: Faith Dugan, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

14–101, Rockville, MD 20857, 301–796–

3446, FAX: 301–847–4752, e-mail: 

Faith.Dugan@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 1, 2007, FDA received a 

citizen petition submitted by a number 

of pediatric health care practitioners 

that raised concerns about the safety 

and efficacy of OTC cough and cold 

products in children less than 6 years 

old. The petition requested that FDA, 

among other actions, amend the OTC 

drug monograph for Cold, Cough, 

Allergy, Bronchodilator, and 

Antiasthmatic Drug Products 

(CCABADP) in 21 CFR part 341 to revise 

the labeling for OTC antitussive, 

expectorant, nasal decongestant, 

antihistamine, and combination cough 

and cold products. The petition 

requested that revised labeling state that 

these products should not be used in 

children under 6 years of age for the 

treatment of cough and cold because the 

products have not been found to be safe 

or effective. In addition, the petition 

requested that the agency notify 

manufacturers of products whose 

labeling either uses such terms as 

‘‘infant’’ or ‘‘baby,’’ or displays images 

of children under the age of 6, that such 

marketing is not supported by scientific 

evidence and that manufacturers will be 

subject to enforcement action at any 

time. The petition and additional 

information can be found at the 

following Web site: http://www.fda.gov/ 

ohrms/dockets/dockets/07p0074/ 

07p0074.htm. 

Many of today’s OTC cough and cold 

medicines are marketed under 

monographs established through the 

OTC Drug Review and published in the 

Code of Federal Regulations. FDA 

initiated the OTC Drug Review in 1972, 

after amendments to the Federal Food, 

Drug, and Cosmetic Act in 1962 

required that drugs be shown to be 

effective as well as safe. Using expert 

advisory panels to review data, the OTC 

Drug Review examined drug ingredients 

marketed OTC in the United States to 

verify which of these ingredients can be 

generally recognized among qualified 

experts as safe and effective for their 

intended uses (GRAS/E). After review 

by the panel, FDA published advance 

notices of proposed rulemaking for 

active ingredients in various therapeutic 

categories to establish monographs 

describing the conditions under which 

the products could be considered 

GRAS/E and marketed under the 

monograph without an approved new 

drug application. Based on the 

recommendations in the panel reports 

and additional public comments and 

data, FDA published a proposed rule, 

also known as a tentative final 

monograph (TFM), which set forth the 

FDA’s views on the conditions of use for 

the monograph. Finally, based on 

additional comments and information 

submitted in response to the TFM, FDA 

published final monographs. The final 

monographs, codified in the Code of 

Federal Regulations, specify the active 

ingredients that are GRAS/E for each 

indication, and for each such active 

ingredient, the permitted dosages, 

claims, and warnings. Products that 

comply with all specified monograph 

conditions may be marketed without 

prior FDA approval. 

Through the OTC Drug Review, FDA 

has established numerous monographs 

for classes of OTC drug ingredients. 

Each completed OTC drug monograph 

considers a particular therapeutic class 

of drugs (e.g., antacids, topical 

antifungal drugs, nighttime sleep aids) 

and describes the active ingredients that 

have been determined to be GRAS/E 

through the OTC Drug Review process, 


ebenthall on PRODPC60 with NOTICES
50034 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

1The FDA issued the tentative final monograph 

for single ingredient OTC cold, cough, allergy, 

bronchodilator, and antiasthmatic drug products in 

segments, over a 3-year period. The first segment, 

on anticholinergic drug product and expectorant 

drug products, was published in the Federal 

Register of July 9, 1982 (47 FR 30002). The second 

segment, on bronchodilator drug products, was 

published in the Federal Register of October 26, 

1982 (47 FR 47520). The third segment, on 

antitussive drug products, was published in the 

Federal Register of October 19, 1983 (48 FR 48576). 

The fourth and fifth segments, on nasal 

decongestant drug products and antihistamine drug 

products, were published in the Federal Register of 

January 15, 1985 (50 FR 2200 and 50 FR 2220). The 

agency’s tentative final monograph for OTC coughcold combination drug products was published in 

the Federal Register of August 12, 1988 (53 FR 

30522). Final monographs for these OTC drug 

products also were published in segments between 

1985 and 1994: Anticholinergic (50 FR 46582, 

November 8, 1985); bronchodilator (51 FR 35326, 

October 2, 1986); antitussive (52 FR 30042, August 

12, 1987); expectorant (54 FR 8494, February 28, 

1989); antihistamine (57 FR 58356, December 9, 

1992); nasal decongestant (59 FR 43386, August 23, 

1994); and combination products (67 FR 78158, 

December 23, 2002). 

2Transcript of joint meeting of the 

Nonprescription Drug Advisory Committee and the 

Pediatric Advisory Committee, October 18, 2007, p. 

10. 

with specifications for the amount of 

drug per dose, labeling, and other 

general requirements. As long as a 

manufacturer uses ingredients (or 

combinations of ingredients) that are 

included in the monograph, and follows 

the monograph specifications in 

manufacturing and marketing, these 

‘‘OTC Monograph’’ products may be 

sold over the counter without FDA preclearance. Drugs that are not covered 

under the OTC Drug Review may be 

marketed OTC under the terms of an 

approved NDA. 

In the Federal Register of September 

9, 1976 (41 FR 38312), FDA published 

an advance notice of proposed 

rulemaking (ANPRM) to establish a 

monograph under § 330.10(a)(6) (21 CFR 

330.10(a)(6)), for OTC cold, cough, 

allergy, bronchodilator, and 

antiasthmatic drug products. At the 

same time, FDA published the 

recommendations of the Advisory 

Review Panel on OTC Cold, Cough, 

Allergy, Bronchodilator, and 

Antiasthmatic Drug Products (the 

Panel), which was the advisory review 

panel that evaluated these products. 

The final CCABADP monograph 

includes GRAS/E active ingredients in 

five separate categories: Antihistamines 

(13 active ingredients), decongestants 

(13 active ingredients), antitussives (10 

active ingredients), bronchodilator (7 

active ingredients), and expectorants (1 

active ingredient).1

Dosing for each active ingredient was 

largely based on the advisory panel 

recommendations, made in consultation 

with the Special Panel on Pediatric 

Dosage. The following statements 

appear in the ANPRM: 

The dosage that will produce optimum 

therapeutic effects in a particular patient, 

adult or child, is dependent upon factors 

such as the drug itself, individual patient 

variables such as special sensitivity or 

tolerance to the specific agent, age, weight 

and metabolic, pathological, or psychological 

conditions. Children’s dosage calculated by 

any method that does not take all of these 

variables into account, therefore, can only be 

considered general guides. 

Definitive pediatric drug dosage should be 

derived from data obtained in clinical trials 

with children using protocols similar to those 

used in adult patients. The Panel recognizes 

the extreme difficulties attendant upon such 

trials but also recognizes the immediate need 

to make recommendations for pediatric 

dosage pending availability of such definitive 

data. 

Traditionally, pediatric dosage calculations 

for infants and children have been based on 

body surface area, weight, or age of the child 

as a proportion of the ‘‘usual adult dose.’’

Dosage calculated on the basis of the age of 

the child, although convenient, may be the 

least reliable method because of the large 

variation in the weight of patients at a 

specific age. However, for OTC products that 

have a relatively wide margin of safety, the 

Panel has concluded that dosage 

recommendations based on age are the most 

reasonable since they would be most easily 

understood by the consumer * * *. 

Unless indicated contrarily, the Panel 

recommends the following guidelines for 

determining safe and effective pediatric 

dosages for the individual [CCABADP] 

ingredients discussed in this document: For 

infants under 2 years of age, the pediatric 

dosage should be established by a physician. 

For children 2 to under 6 years of age, the 

pediatric dosage is 1/4 the adult dosage; for 

children 6 to under 12 years of age, the 

dosage is 1/2 the adult dosage * * *. 

The differences between children under 2 

years of age, and other age groups with 

respect to the anatomy and physiology 

disorders of their respiratory system, their 

responses to diseases affecting the respiratory 

system, and their responses to drugs make 

general labeling restrictions for this age group 

essential. For example, infants because of the 

smaller diameter of their respiratory airways 

are particularly prone to the complications of 

respiratory distress during an acute 

respiratory tract infection such as may occur 

in the ‘‘common cold.’’ Therefore, parents of 

children under 2 years of age should be 

advised to consult a physician for diagnosis 

and individualized therapeutic 

recommendations, even for symptoms and 

conditions that are considered appropriate 

for self-medication in older children and 

adults. Because of these considerations, the 

Panel recommends that the general labeling 

of [CCABADP] products for use in children 

under 2 years of age requires the advice and 

supervision of a physician * * *. 

41 FR 38312; 38333 (September 9, 

1976). 

We estimate that there are 

approximately 10,000 products being 

marketed for cold, cough, or combined 

indications under the OTC Drug 

Review. (See 67 FR 78158 at 78166.) 

Depending on the dosage form and 

strength of these products, many of 

them are labeled for pediatric use, 

including some that are labeled for use 

in both adults and children. There are 

approximately 38 active ingredients in 

the final CCABADP monograph. Some 

combination cough and cold products 

contain as many as four of these active 

ingredients in a single dosage form, 

meaning that patients may be exposed 

to four different active ingredients when 

using a single product. From 2002 to 

2006, there were approximately 36 

billion units of combination cough and 

cold products sold each year in the 

United States. For liquid formulations 

used for the youngest children, there 

were approximately 190 million units 

sold each year in the combined cough 

and cold categories during this period.2

During the past decade, there have 

been several important new 

developments in the evaluation of safety 

and efficacy of drugs for pediatric use. 

First, the Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Public Law 105–115) (Nov. 21, 1997) 

was enacted, and included a provision 

to create voluntary incentives to 

develop medications for use in the 

pediatric population. This program was 

reauthorized and expanded first in the 

Best Pharmaceuticals for Children Act 

of 2002 (Public Law 107–109) (January 

4, 2002), and then again in Title V of the 

FDA Amendments Act of 2007 

(FDAAA) (Public Law 110–85) 

(September 27, 2007). The Pediatric 

Research Equity Act (PREA) of 2003 

required that drugs be studied in 

pediatric patients in certain 

circumstances. The PREA requirements 

were reauthorized and expanded by 

Title IV of FDAAA in 2007. Collectively, 

these laws recognize that differences in 

metabolism between adults and 

children, as well as differences between 

pediatric age groups, may require 

individualized dosing. They also 

recognize that there are often differences 

in effects of drugs and in adverse events 

observed in pediatric patients when 

compared to adult patients. Although 

these laws do not apply to products 

marketed under an OTC monograph, 

data from studies performed under these 

provisions suggest that children are not 

small adults, but rather may have a 

response to medication, both beneficial 

and adverse, that is different from 

adults. 

Given the evolution in our thinking 

about the use of drugs in children, the 

passage of more than 30 years since the 


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Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50035 

3Schaefer MK, Shehab N, Cohen AL, Budnitz DS. 

Adverse Events From Cough and Cold Medications 

in Children. Pediatrics 2008;121;783–787; originally 

published online Jan 28, 2008. 

4Boston University’s Slone Epidemiology Center 

presention at the 2008 Pediatric Academic 

Societies’ & Asian Society for Pediatric Research 

Joint Meeting in Honolulu, Hawaii. Vernacchio L, 

Kelly JP, Kaufman DW, Mitchell AA. Cough and 

Cold Medication Use by US Children, 1999–2006: 

Results From the Slone Survey, Pediatrics 2008; 

122:e323-e329. 

recommendations from the advisory 

review panels were made, and the 

concerns about pediatric cough and cold 

products that have been presented to 

FDA, including those raised by the 

March 1, 2007, citizen petition, the 

agency has taken a new look at the 

assumptions that were used to create the 

pediatric conditions for cough and cold 

medicines contained in the CCABADP 

monograph. As part of this review, FDA 

convened a joint meeting of the 

Nonprescription Drugs Advisory 

Committee and the Pediatric Advisory 

Committee on October 18 and 19, 2007, 

to discuss the safety and efficacy of 

these OTC cough and cold products 

marketed for pediatric use. The 

discussion at the Advisory Committee 

meeting addressed a variety of issues 

including the extrapolation of efficacy 

data from adults to children of any age 

for cough and cold products; the safety 

profile of these products in children; the 

basis for dosing recommendations in the 

CCABADP monograph and the use of 

pharmacokinetic data to determine 

appropriate dosing in children; the basis 

of dosing recommendations for various 

age intervals of less than 2 years, 2 to 

5 years of age, and 6 to 11 years of age; 

the use of the products in children less 

than 2 years of age; the potential for 

misuse, unintentional overdose, and 

excessive dosing; the ability of parents 

or caregivers to correctly dose and 

administer cough and cold products to 

their children; and the labeling changes 

recommended by the petitioner and the 

effects they would have on the use of 

these products in children and the 

recommendations of health care 

providers. The 22 person Advisory 

Committee was nearly unanimous in 

agreeing that new studies were 

necessary because extrapolation of 

efficacy data for the common cold 

indication from adults to children was 

not acceptable for children less than 2 

years old or for children 2 years to less 

than 12 years. The vote was 22 to 0 and 

21 to 1, respectively, for the two age 

groups. The committee understood that 

changing the OTC drug monographs 

required rulemaking that would take 

several years to complete. The Advisory 

Committee also voted 13 to 9 to 

recommend that pediatric cough and 

cold drugs should not be used for 

children under 6 years of age while 

rulemaking proceeded, and voted 15 to 

7 to recommend that the products 

should continue, for the time being, to 

be sold for use in children ages 6 to 

under 12 while new studies are 

conducted. 

On January 17, 2008, FDA issued a 

Public Health Advisory (PHA) available 

at: http://www.fda.gov/cder/drug/ 

advisory/cough_cold_2008.htm. The 

PHA recommended that these drugs not 

be used to treat infants and children 

under 2 years of age because serious and 

potentially life-threatening side effects 

can occur. The PHA also indicated that 

FDA had not yet completed its review 

of the safety of these medicines in 

children 2 through 11, and the agency 

committed to completing the review as 

quickly as possible. Pending completion 

of this review, the PHA recommended a 

number of precautions for parents and 

caregivers using OTC cough and cold 

medicines in children 2 years of age and 

older, including carefully following the 

directions in the Drug Facts label; using 

appropriate measuring spoons or 

instruments made for measuring 

medicines; choosing products with 

safety caps; avoiding concurrent use of 

different OTC cough and cold 

medications to avoid unintentional 

overdose; not using these products to 

sedate children; and consulting a 

physician, pharmacist, or other health 

care professional with any questions 

about using these products in children. 

In the PHA, we also announced strong 

support for the voluntary action taken 

by many pharmaceutical manufacturers 

to withdraw cough and cold medicines 

that were being sold for use in children 

under 2 years of age. 

Since we issued the Public Health 

Advisory, we have continued our 

review of available data concerning the 

use of cough and cold medications in 

children, including information from 

the Advisory Committee meeting about 

the efficacy of the products, information 

from FDA’s drug Adverse Event 

Reporting (AERS) database, and a 

published report in the medical 

literature from the Centers for Disease 

Control and Prevention (CDC) about 

children who ingested cough and cold 

medicines and had side effects that were 

serious enough to require an emergency 

room visit.3 While many of the observed 

adverse events were due to overdoses 

associated with accidental ingestions or 

dosing errors, allergic and non-allergic 

adverse events occurred with the 

labeled dose in children. FDA reviewed 

the CDC study and underlying data, 

particularly looking at the type of events 

that occurred with the labeled dose of 

OTC cough and cold medications, and 

noted that children under 4 years of age 

are more likely to experience nonallergic adverse events than older 

children. 

Cough and cold products are 

commonly used in children. A recent 

report suggested that 1 in 10 children 

uses one or more cough and cold 

products during a given week with 

exposure being highest among 2 to 5 

year olds, and high in children under 2.4

Based on the number of cases of serious 

adverse events reported to FDA and the 

number of serious adverse events in the 

CDC emergency room study, we believe 

that serious adverse events are relatively 

rare given the extensive use of the drug 

products. 

Despite the fact that serious adverse 

events are relatively rare in children 

using cough and cold drugs, we have 

determined that the collection of 

additional data using modern standards 

is warranted to support the current 

dosing or to establish new dosing 

regimens for children, given the 

concerns that have been raised about the 

safety and efficacy of these products, 

particularly in younger age groups. Lack 

of safety and efficacy data for specific 

pediatric age groups also inhibits the 

conduct of a meaningful risk benefit 

analysis under 21 CFR 330.10(a)(4)(iii). 

We recognize that many scientific 

issues must be addressed and resolved 

to support the development and review 

of data that, in the long term, will 

provide increased confidence in the safe 

and effective pediatric use of these OTC 

cough and cold products, either under 

the monograph or approved NDAs. FDA 

has decided to hold a Part 15 hearing to 

hear from the public, including parents, 

health care practitioners, manufacturers 

of cough and cold products, retailers, 

and other interested persons, about 

these issues. FDA will consider this 

public input in developing a proposed 

rule to amend the CCABADP 

monograph to reflect the new data and 

any appropriate changes to the 

conditions necessary to ensure that 

these medications can be considered 

GRAS/E. 

II. Scope of Hearing 

FDA is interested in obtaining public 

comment on the following issues 

relating to the use of pediatric cough 

and cold medicines: 

1. What types of studies, if any, 

should be conducted to assess 

effectiveness and/or safety, and 


ebenthall on PRODPC60 with NOTICES
50036 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

determine appropriate dosing of cough 

and cold ingredients in the pediatric 

population? How should these studies 

be designed and powered? 

2. Should cough and cold products for 

the pediatric population continue to be 

available OTC, or should they be made 

available only by prescription? 

3. If the pediatric indications and 

dosing for cough and cold products 

were no longer available OTC, would 

the public use the adult formulations of 

the OTC monograph products for 

children, and thus create a greater risk 

of misuse or overdose? 

4. Do the answers to the previous 

questions depend on the age of the 

pediatric patients? If so, how should age 

be considered in making regulatory 

decisions for these products? 

5. At the time the monograph was 

established, FDA routinely extrapolated 

safety and efficacy data from adults to 

children age 12 and over. Current PREA 

standards permit extrapolation of 

pediatric efficacy -- but not safety-- 

based upon sufficient adult data. Does it 

remain appropriate to recommend in the 

cough and cold monograph that 

children 12 and over should receive the 

same dose of medication as adults, 

without requiring any additional studies 

in children in this age group? What 

additional safety and/or efficacy studies 

should be required in this age group? 

6. What is the most appropriate 

method for determining pediatric doses 

that could be used as an alternative to 

the quarter- and half-dose assumptions 

used in the monograph? Should 

products be dosed by age, by weight, or 

both? 

7. There are monographs for topical 

and intranasal ingredients to treat the 

common cold. Should these 

monographs be considered in a similar 

fashion to the oral cough and cold 

products? Are the answers to the 

previous questions different for any 

subcategories of cough and cold 

medicines (e.g., topical or intranasal 

products)? 

8. The CCABADP monograph allows 

for the combination of ingredients to 

treat colds and/or coughs. Should 

combination products be permitted for 

all pediatric age groups? Should data be 

provided to support each unique 

combination? 

9. Can measurement errors in dosing 

be reduced using more standardized 

measuring devices or alternative dosage 

forms and, if so, what is the best way 

to effect this change? 

III. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner is announcing that 

the public hearing will be held in 

accordance with part 15 (21 CFR part 

15). The hearing will be conducted by 

a presiding officer, accompanied by 

FDA senior management from the Office 

of the Commissioner and the Center for 

Drug Evaluation and Research. 

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10 (21 CFR part 10), 

subpart C)). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). To the extent that the 

conditions for the hearing, as described 

in this document, conflict with any 

provisions set out in part 15, this 

document acts as a waiver of those 

provisions as specified in 21 CFR 

15.30(h). 

IV. Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

written or electronic comments to the 

Division of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments should be identified 

with the docket number found in 

brackets in the heading of this 

document. To ensure consideration, 

submit comments by (see DATES). 

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 through FDMS only. 

V. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript will also 

be available in either hard copy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of participation and comments for 

consideration. 

Dated: August 20, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19657 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60-Day 

Proposed Information Collection: 

Indian Health Service; HIV Knowledge/ 

Attitudes/Practice Customer Survey 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 which requires 

60 days for public comment on 

proposed information collection 

projects, the Indian Health Service (IHS) 

is publishing for comment a summary of 

a proposed information collection to be 

submitted to the Office of Management 

and Budget (OMB) for review. 

Proposed Collection: Title: 0917–

NEW, ‘‘Indian Health Service HIV 

Knowledge/Attitudes/Practice Customer 

Survey.’’ Type of Information Collection 

Request: This is a one time survey to 

deliver the mission of the IHS and 

Centers for Disease Control (CDC) 

national guidelines collection, 0917–

NEW, ‘‘Indian Health Service HIV 

Knowledge/Attitudes/Practice Customer 

Survey.’’ Form(s): The Indian Health 

Service Customer Survey. Need and Use 

of Information Collection: 

The IHS goal is to raise the health 

status of the American Indian and 

Alaska Native (AI/AN) people to the 

highest possible level by providing 

comprehensive health care and 

preventive health services. To support 

the IHS mission, the Division of 

Epidemiology and Disease Prevention 

(DEDP) and the Human 

Immunodeficiency Virus (HIV) Program 

collaborate to provide programmatic, 

technical, and financial assistance to 


ebenthall on PRODPC60 with NOTICES