80 FR 63799 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 203 (October 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 203 (October 21, 2015)
| Page Range | 63799-63802 | |
| FR Document | 2015-26671 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Notices] [Pages 63799-63802] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26671] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2126] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 20, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the title ``Evaluation of the Food and Drug Administration's Campaign to Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults''. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Evaluation of FDA's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults--OMB Control Number 0910--New The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing public education campaigns to help prevent and reduce tobacco use among lesbian, gay, bisexual, and transgender (LGBT) young adults and thereby reduce the public health burden of tobacco. Overall the campaigns will feature events; advertisements on television and radio and in print; digital communications including social media; and other forms of media. In support of the provisions of the Tobacco Control Act that require FDA to protect the public health and to reduce tobacco use, FDA requests OMB approval to collect information needed to evaluate FDA's campaign to reduce tobacco use among LGBT young adults. Comprehensive evaluation of FDA's public education campaigns is needed to ensure campaign messages are effectively received, understood, and accepted by those for whom they are intended. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. FDA plans to conduct two studies to evaluate the effectiveness of its LGBT young adult tobacco prevention campaign: (1) An outcome evaluation study to evaluate the effectiveness of its LGBT young adult tobacco prevention campaign, and (2) a media tracking questionnaire to assess awareness of and receptivity to campaign messages. The timing of these studies will be designed to follow the multiple, discrete waves of media advertising planned for the campaigns. I. Outcome Evaluation Study Before the beginning of data collection for the outcome evaluation study, the 5-minute screening instrument will be tested in a small pilot study of LGBT young adults aged 18 to 24. The outcome evaluation study will then begin with a baseline survey of LGBT young adults aged 18 to 24 before the campaign launch. The baseline will be followed by three followup surveys of the target audience of young adults at approximately 6-month intervals after the campaign's launch. Information will be collected [[Page 63800]] about young adult awareness of and exposure to campaign events and advertisements and about tobacco-related knowledge, attitudes, beliefs, intentions and use, as well as use of other tobacco products (e- cigarettes, hookah, cigars, smokeless tobacco), marijuana and alcohol. Information will also be collected on demographic variables including sexual orientation, age, sex, race/ethnicity, education, and primary language. All information will be collected through in-person and Web-based questionnaires. Young adult respondents will be recruited in 24 U.S. cities (12 campaign and 12 comparison cities) from two sources: (1) Intercept surveys in LGBT social venues (e.g., bars and nightclubs) and (2) through social media advertisements (e.g. on Facebook and Twitter) targeted at LGBT 18 to 24-year-olds, living in the same 24 U.S. cities. Participation in the study is voluntary. II. Media Tracking Survey The media tracking survey consists of assessments of LGBT young adults aged 18 to 24 conducted in the periods in between the primary outcome evaluation survey waves to monitor the target audience's awareness of and receptivity to campaign activities. The media tracking survey will assess awareness of the campaign and receptivity to campaign messages. These data will provide critical evaluation feedback to the campaigns and will be conducted with sufficient frequency to match the cyclical patterns of events and media advertising and variation in exposure to allow for mid-campaign refinements. For the media tracking surveys, we will recruit LGBT young adults aged 18 to 24 from all campaign cities through social media. The information collected is necessary to inform FDA's efforts and measure the effectiveness and public health impact of the campaigns. Data from the media tracking surveys will be used to estimate awareness of and exposure to the campaigns among young adults in target markets where the campaigns are active. Data from the outcome evaluation study will be used to examine statistical associations between awareness of and exposure to the campaigns and subsequent changes in specific outcomes of interest, which will include knowledge, attitudes, beliefs, and intentions related to tobacco use. FDA's burden estimate is based on prior experience with in-person studies similar to the Agency's plan presented in this document, as well as previous research using social media advertising to recruit young adult participants. Since the 60-day notice was published, FDA has revised the estimated burden. The estimated burden has been revised to account for both participant eligibility and response rates among participants to be recruited via in-person intercept screening in LGBT bars and night clubs as only response rates were estimated in the 60- day notice. In addition, the burden table presented in this document now reports the annual burden estimate, which has been corrected from the 60-day notice, which reported total burden (rather than annual burden). To reduce overall burden hours, participants who screen and complete the baseline outcome evaluation questionnaire will be re- contacted to complete the first followup campaign evaluation questionnaire; those who complete the first followup campaign evaluation questionnaire will be re-contacted to complete the second followup campaign evaluation questionnaire; and so on. Re-contacted individuals will not need to complete the screener again. We expect a 65 percent eligibility rate and 50 percent response rate for individuals recruited in person and a combined eligibility and response rate of 30 percent for individuals recruited via social media. In each successive round of data collection, we expect 50 percent of re- contacted individuals to complete the followup questionnaire; therefore, additional screenings will be conducted for each followup in order to maintain the target sample size for each followup questionnaire. In-person recruitment will take place in a variety of LGBT venues (e.g., bars, nightclubs). The owners or managers of potential recruitment sites will be asked a series of questions to determine the appropriateness of its clientele for participation in the study. Approximately 1,920 venues (640 annualized) will be assessed at 5 minutes per assessment for a total of 159 hours (53 annualized). To obtain the target number of completed questionnaires (``completes'') for the outcome evaluation study, 24,744 (8,248 annualized, or annually over the 3-year approval period) young adults (18,177 (6,059 annualized) recruited in person and 6,567 (2,189 annualized) recruited via social media) will participate in a screening process (``screener''). The estimated burden per screener is 5 minutes (0.083 hour), for a total of 2,055 hours (685 annualized) (1,512 hours (504 annualized) for participants recruited in person and 543 hours (181 annualized) for persons recruited via social media). Before the beginning of data collection, the 5-minute screener will be tested in a small pilot study of 81 young adults (27 annualized) for a total of 6 hours (2 hours annualized). A total of 12,612 (4,204 annualized) LGBT young adults (9,456 (3,152 annualized) of those screened in person and 3,156 (1,052 annualized) of those screened through social media) will complete questionnaires in four rounds of data collection (baseline and three post-campaign rounds). The estimated burden per complete is 30 minutes (0.5 hour) for the baseline questionnaire and 40 minutes (0.667 hour) for each followup complete, for a total of 7,884 hours (2,628 annualized) (5,916 hours (1,972 annualized) for those recruited in person and 1,968 hours (656 annualized) for those recruited via social media). To obtain the target number of completes (1,503 completes (501 annualized)) for the media tracking survey, 5,004 (1,668 annualized) young adults will be recruited via social media ads to complete a screener for all three waves of the media tracking survey. The estimated burden per screener response is 5 minutes (0.083 hour), for a total of 415 (138 annualized) hours for all waves of media tracking screener. An estimated 501 (167 annualized) LGBT young adults will complete each of the three waves of the media tracking survey (assuming a 30 percent combined eligibility and response rate to screeners via social media). The estimated burden per completed media tracking questionnaire is 40 minutes (0.667 hour), for a total of 999 (333 annualized) hours for the three waves. The total burden for the media tracking survey (screeners and completes) is 1,413 hours (471 annualized). The target number of completed campaign questionnaires (i.e., screeners and questionnaires for both the outcome evaluation and media tracking survey) for all respondents is 45,864 (15,288 annualized). The total estimated burden is 11,517 (3,839 annualized). In the Federal Register of June 30, 2015 (80 FR 37270), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two comments; however only one was PRA related. (Comment) The commenter did not believe the amount of hours was justified for learning about the LGBT population. Additionally, the commenter did not see an explanation of the value of collecting this information. (Response) FDA disagrees with this comment. The Tobacco Control Act [[Page 63801]] authorized FDA to develop and implement several public health education campaigns about the dangers of using tobacco products. Through literature reviews and analysis of national survey data, FDA identified groups that are uniquely at-risk of tobacco initiation due to a variety of factors, and who would benefit from an innovative education campaign designed to prevent tobacco use. One such group is young adults who identify as LGBT who, according to recent data, smoke at approximately two times the rate of the general adult population. FDA is currently developing a national campaign targeting LGBT young adults ages 18-24 years. The purpose of the proposed study is to evaluate the campaign's reach and its effectiveness in changing their knowledge, beliefs, and attitudes regarding tobacco. FDA's public health education campaigns are a necessary and worthwhile investment to reduce the significant burden of tobacco use and ultimately make tobacco a part of America's past, not its future. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Number of Number of Total annual burden per Total annual Type of respondent Activity respondents responses per responses response (in hours respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Venue owners and managers................. Venue recruitment assessment 640 1 640 0.083 53 ------------------------------------------------------------------------------- Total Venue Recruitment............... ............................ 640 1 640 .............. 53 General Population: Pilot test of Screener--Pilot study....... 27 1 27 0.083 2 recruitment social media recruitment. ------------------------------------------------------------------------------- Total Screener Pilot.................. ............................ 27 1 27 0.083 2 Screener: General population--Recruited in Screener--Baseline, outcome person (65% screen as eligible). study. 2,423 1 2,423 0.083 201 Screener--First followup, .............. .............. .............. .............. .............. outcome study. 1,212 1 1,212 0.083 101 Screener--Second followup, .............. .............. .............. .............. .............. outcome study. 1,212 1 1,212 0.083 101 Screener--Third followup, .............. .............. .............. .............. .............. outcome study. 1,212 1 1,212 0.083 101 Screeners: In person...................... ............................ 6,059 .............. 6,059 .............. 504 Screener: General population--Recruited Screener--Baseline, outcome via social media. study. 875 1 875 0.083 73 Screener--First followup, .............. .............. .............. .............. .............. outcome study. 438 1 438 0.083 36 Screener--Second followup, .............. .............. .............. .............. .............. outcome study. 438 1 438 0.083 36 Screener--Third followup, .............. .............. .............. .............. .............. outcome study. 438 1 438 0.083 36 Screeners: Social media................... ............................ 2,189 .............. 2,189 .............. 181 ------------------------------------------------------------------------------- Total screeners....................... ............................ 8,248 .............. 8,248 .............. 685 Outcome Study LGBT young adults aged 18-24 Questionnaire--Baseline in select media markets--Recruited in outcome study. 788 1 788 0.5 394 person (50% response rate). Questionnaire--First .............. .............. .............. .............. .............. followup, outcome study. 788 1 788 0.667 526 Questionnaire--Second .............. .............. .............. .............. .............. followup, outcome study. 788 1 788 0.667 526 Questionnaire--Third .............. .............. .............. .............. .............. followup, outcome study. 788 1 788 0.667 526 Completes: Screened in person............. ............................ 3,152 .............. 3,152 .............. 1,972 Outcome Evaluation: LGBT young adults aged Questionnaire--Baseline 18-24 in select media markets--Recruited outcome study. 263 1 263 0.5 131 via social media (30% combined Questionnaire--First .............. .............. .............. .............. .............. eligibility and response rate). followup, outcome study. 263 1 263 0.667 175 Questionnaire--Second .............. .............. .............. .............. .............. followup, outcome study. 263 1 263 0.667 175 Questionnaire--Third .............. .............. .............. .............. .............. followup, outcome study. 263 1 263 0.667 175 Completes: Recruited online............... ............................ 1,052 .............. 1,052 .............. 656 ------------------------------------------------------------------------------- Total completes (recruited in person ............................ 4,204 .............. 4,204 .............. 2,628 and recruited online). [[Page 63802]] LGBT young adults aged 18-24 in the select Screener--First media media markets--Recruited via social media tracking. 556 1 556 0.083 46 (30% combined eligibility and response Screener--Second media .............. .............. .............. .............. .............. rate). tracking. 556 1 556 0.083 46 Screener--Third media .............. .............. .............. .............. .............. tracking. 556 1 556 0.083 46 Media tracking screeners.................. ............................ 1,668 .............. 1,668 .............. 138 LGBT young adults aged 18-24 in the select Questionnaire--First media media markets--Recruited via social media tracking. 167 .............. 167 0.667 111 (30% combined eligibility and response Questionnaire--Second media .............. .............. .............. .............. .............. rate). tracking. 167 1 167 0.667 111 Questionnaire--Third media .............. .............. .............. .............. .............. tracking. 167 1 167 0.667 111 Media tracking questionnaires............. ............................ 501 .............. 501 .............. 333 ------------------------------------------------------------------------------- Total media tracking (screeners and ............................ 2,169 .............. 2,169 .............. 471 questionnaires). ------------------------------------------------------------------------------- Totals Across All Study Components ............................ 15,288 .............. 15,288 .............. 3,839 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26671 Filed 10-20-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices 63799
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden
21 U.S.C. section records per Total hours
recordkeepers records per recordkeeping
recordkeeper
Dietary supplement adverse event records (21 1,700 74 125,800 0.5 (30 minutes) ........ 62,900
U.S.C. 379aa–1(e)(1)).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
All dietary supplement ACTION: Notice. related to tobacco use. Accordingly,
manufacturers, packers, or distributors FDA is currently developing and
are subject to serious adverse event SUMMARY: The Food and Drug implementing public education
recordkeeping. We estimate that there Administration (FDA) is announcing campaigns to help prevent and reduce
are 1,700 such respondents, based on that a proposed collection of tobacco use among lesbian, gay,
the figure 1,460 as provided in our final information has been submitted to the bisexual, and transgender (LGBT) young
rule of June 25, 2007 (72 FR 34751) on Office of Management and Budget adults and thereby reduce the public
the ‘‘Current Good Manufacturing (OMB) for review and clearance under health burden of tobacco. Overall the
Practice in Manufacturing, Packaging, the Paperwork Reduction Act of 1995. campaigns will feature events;
Labeling, or Holding Operations for DATES: Fax written comments on the advertisements on television and radio
Dietary Supplements,’’ and factoring a collection of information by November and in print; digital communications
two percent annual growth rate. 20, 2015. including social media; and other forms
Estimating that each recordkeeper will ADDRESSES: To ensure that comments on of media.
keep approximately 74 records per year the information collection are received, In support of the provisions of the
results in an annual burden of 125,800 OMB recommends that written Tobacco Control Act that require FDA to
records. Estimating that assembling and comments be faxed to the Office of protect the public health and to reduce
filing these records, including any Information and Regulatory Affairs, tobacco use, FDA requests OMB
necessary photocopying, will take OMB, Attn: FDA Desk Officer, FAX: approval to collect information needed
approximately 30 minutes, or 0.5 hours, 202–395–7285, or emailed to oira_ to evaluate FDA’s campaign to reduce
per record, results in an annual burden submission@omb.eop.gov. All tobacco use among LGBT young adults.
of 62,900 hours (125,800 records × 0.50 comments should be identified with the Comprehensive evaluation of FDA’s
hours = 62,900 total hours. title ‘‘Evaluation of the Food and Drug public education campaigns is needed
Once the documents pertaining to an Administration’s Campaign to Reduce to ensure campaign messages are
adverse event report have been Tobacco Use Among Lesbian, Gay, effectively received, understood, and
assembled and filed in accordance with Bisexual, and Transgender Young accepted by those for whom they are
the safety reporting portal, we expect Adults’’. Also include the FDA docket intended. Evaluation is an essential
the records retention burden to be number found in brackets in the organizational practice in public health
minimal, as we believe most heading of this document. and a systematic way to account for and
establishments would normally keep FOR FURTHER INFORMATION CONTACT: FDA improve public health actions.
this kind of record for at least several PRA Staff, Office of Operations, Food FDA plans to conduct two studies to
years after receiving the report, as a and Drug Administration, 8455 evaluate the effectiveness of its LGBT
matter of usual and customary business Colesville Rd., COLE–14526, Silver young adult tobacco prevention
practice. Spring, MD 20993–0002, PRAStaff@ campaign: (1) An outcome evaluation
fda.hhs.gov. study to evaluate the effectiveness of its
Dated: October 15, 2015.
SUPPLEMENTARY INFORMATION: In LGBT young adult tobacco prevention
Leslie Kux,
compliance with 44 U.S.C. 3507, FDA campaign, and (2) a media tracking
Associate Commissioner for Policy. questionnaire to assess awareness of and
has submitted the following proposed
[FR Doc. 2015–26673 Filed 10–20–15; 8:45 am] receptivity to campaign messages. The
collection of information to OMB for
BILLING CODE 4164–01–P review and clearance. timing of these studies will be designed
to follow the multiple, discrete waves of
Evaluation of FDA’s Campaign To media advertising planned for the
DEPARTMENT OF HEALTH AND Reduce Tobacco Use Among Lesbian, campaigns.
HUMAN SERVICES Gay, Bisexual, and Transgender Young
Adults—OMB Control Number 0910— I. Outcome Evaluation Study
Food and Drug Administration New Before the beginning of data
The 2009 Family Smoking Prevention collection for the outcome evaluation
[Docket No. FDA–2015–N–2126] and Tobacco Control Act (Tobacco study, the 5-minute screening
Agency Information Collection Control Act) (Pub. L. 111–31) amended instrument will be tested in a small
Activities; Submission for Office of the Federal Food, Drug, and Cosmetic pilot study of LGBT young adults aged
Management and Budget Review; Act (the FD&C Act) to grant FDA 18 to 24. The outcome evaluation study
Comment Request; Evaluation of the authority to regulate the manufacture, will then begin with a baseline survey
tkelley on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration’s marketing, and distribution of tobacco of LGBT young adults aged 18 to 24
Campaign To Reduce Tobacco Use products to protect public health and to before the campaign launch. The
Among Lesbian, Gay, Bisexual, and reduce tobacco use by minors. Section baseline will be followed by three
Transgender Young Adults 1003(d)(2)(D) of the FD&C Act (21 followup surveys of the target audience
U.S.C. 393(d)(2)(D)) supports the of young adults at approximately 6-
AGENCY: Food and Drug Administration, development and implementation of month intervals after the campaign’s
HHS. FDA public education campaigns launch. Information will be collected
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![63802 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Average
Number of
Number of Total annual burden per Total annual
Type of respondent Activity responses per
respondents responses response hours
respondent (in hours)
LGBT young adults aged Screener—First media
18–24 in the select media tracking. 556 1 556 0.083 46
markets—Recruited via Screener—Second media
social media (30% com- tracking. 556 1 556 0.083 46
bined eligibility and re- Screener—Third media
sponse rate). tracking. 556 1 556 0.083 46
Media tracking screeners .... ............................................. 1,668 ........................ 1,668 ........................ 138
LGBT young adults aged Questionnaire—First media
18–24 in the select media tracking. 167 167 0.667 111
markets—Recruited via Questionnaire—Second
social media (30% com- media tracking. 167 1 167 0.667 111
bined eligibility and re- Questionnaire—Third media
sponse rate). tracking. 167 1 167 0.667 111
Media tracking question- ............................................. 501 ........................ 501 ........................ 333
naires.
Total media tracking ............................................. 2,169 ........................ 2,169 ........................ 471
(screeners and ques-
tionnaires).
Totals Across All ............................................. 15,288 ........................ 15,288 ........................ 3,839
Study Compo-
nents.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015. intends to consider to determine identifies you in the body of your
Leslie Kux, whether a preapproval inspection is comments, that information will be
Associate Commissioner for Policy. necessary before approval of the PMA posted on http://www.regulations.gov.
[FR Doc. 2015–26671 Filed 10–20–15; 8:45 am] supplement. This draft guidance is not • If you want to submit a comment
BILLING CODE 4164–01–P final nor is it in effect at this time. with confidential information that you
DATES: Although you can comment on do not wish to be made available to the
any guidance at any time (see 21 CFR public, submit the comment as a
DEPARTMENT OF HEALTH AND 10.115(g)(5)), to ensure that the Agency written/paper submission and in the
HUMAN SERVICES considers your comment of this draft manner detailed (see ‘‘Written/Paper
guidance before it begins work on the Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration final version of the guidance, submit Written/Paper Submissions
[Docket No. FDA–2015–N–3454] either electronic or written comments
Submit written/paper submissions as
on the draft guidance by January 19,
Manufacturing Site Change follows:
2016. • Mail/Hand delivery/Courier (for
Supplements: Content and ADDRESSES: You may submit comments written/paper submissions): Division of
Submission; Draft Guidance for as follows: Dockets Management (HFA–305), Food
Industry and Food and Drug
Electronic Submissions and Drug Administration, 5630 Fishers
Administration Staff; Availability
Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Submit electronic comments in the • For written/paper comments
HHS. following way: submitted to the Division of Dockets
ACTION: Notice. • Federal eRulemaking Portal: http:// Management, FDA will post your
www.regulations.gov. Follow the comment, as well as any attachments,
SUMMARY: The Food and Drug instructions for submitting comments. except for information submitted,
Administration (FDA) is announcing the Comments submitted electronically, marked and identified, as confidential,
availability of the draft guidance including attachments, to http:// if submitted as detailed in
entitled ‘‘Manufacturing Site Change www.regulations.gov will be posted to ‘‘Instructions.’’
Supplements: Content and the docket unchanged. Because your Instructions: All submissions received
Submission’’. This draft guidance comment will be made public, you are must include the Docket No. FDA–
describes the decision-making steps that solely responsible for ensuring that your 2015–N–3454 for ‘‘Manufacturing Site
FDA recommends to determine whether comment does not include any Change Supplements: Content and
a premarket approval application (PMA) confidential information that you or a Submission.’’ Received comments will
tkelley on DSK3SPTVN1PROD with NOTICES
supplement should be submitted when third party may not wish to be posted, be placed in the docket and, except for
a manufacturer intends to change the such as medical information, your or those submitted as ‘‘Confidential
manufacturing site (including a change anyone else’s Social Security number, or Submissions,’’ publicly viewable at
to the processing, packaging, or confidential business information, such http://www.regulations.gov or at the
sterilization site) of its legally marketed as a manufacturing process. Please note Division of Dockets Management
PMA-approved device. This guidance that if you include your name, contact between 9 a.m. and 4 p.m., Monday
also discusses the general factors FDA information, or other information that through Friday.
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Document Created: 2018-02-27 08:53:58
Document Modified: 2018-02-27 08:53:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by November 20, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 63799 |
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